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Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels

Sponsor
Medtronic Spinal and Biologics (Industry)
Overall Status
Completed
CT.gov ID
NCT00637156
Collaborator
(none)
397
Enrollment
29
Locations
2
Arms
140.1
Duration (Months)
13.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease at two adjacent levels of the cervical spine, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will also be examined as the secondary objective.

Condition or Disease Intervention/Treatment Phase
  • Device: PRESTIGE LP device at two adjacent levels
  • Device: Bi-level fusion with ATLANTIS Cervical Plate System
 N/A

Detailed Description

This clinical investigation is being conducted to evaluate the PRESTIGE-LP device's performance at two adjacent cervical levels (C3-C7) in the treatment of patients with symptomatic degenerative disc disease. One-half of the patients in this randomized pivotal clinical trial will be treated at two adjacent cervical levels with the PRESTIGE-LP device. The remaining patients will receive a bi-level anterior cervical discectomy and fusion with cortical ring allografts and the ATLANTIS Cervical Plate System.

Study Design

Study Type:
Interventional
Actual Enrollment :
397 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized, Controlled, Multicenter Pivotal Clinical Trial of the Artificial Cervical Disc-LP at Two Levels for Symptomatic Cervical Disc Disease
Study Start Date :
Jun 1, 2006
Actual Primary Completion Date :
Jan 1, 2011
Actual Study Completion Date :
Feb 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: PRESTIGE LP Device

Device: PRESTIGE LP device at two adjacent levels
PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
Other Names:
  • disc
  • artificial disc
  • cervical disc

    		•
    Other: ATLANTIS Cervical Plate System

    Device: Bi-level fusion with ATLANTIS Cervical Plate System
    Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Other Names:
  • plate
  • cervical plate
  • fusion
  • cervical fusion

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of Overall Success [24 Months]

      Rate of overall success is reported as the percentage of participants who met all of the following criteria: Postoperative Neck Disability Index (NDI) score improvement of at least a 15-point increase from preoperative; Maintenance or improvement in neurological status; No serious adverse event classified as implant associated or implant/surgical procedure associated; and No additional surgical procedure classified as a "failure."

    Secondary Outcome Measures

    1. Success Rate of Neck Disability Index [24 months]

      Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met the following criterion: Pre-treatment Score - Post-treatment Score ≥ 15.

    2. Success Rate of Neurological Status [24 months]

      Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must either remain the same or improve from the time of the preoperative evaluation to the time period evaluated.

    3. Neck Pain Success Rate [24 months]

      Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0.

    4. Arm Pain Success Rate [24 months]

      Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0.

    5. Success Rate of SF-36 PCS [24 months]

      Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.

    6. Success Rate of SF-36 MCS [24 months]

      Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.

    7. Rate of Disc Height Success [24 months]

      Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height >= -2mm

    8. Gait Success Rate [24 months]

      Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score >= 0. The gait success rate is reported as the percentage of participants who had gait success.

    9. Operative Time [Time of operation, an average of 1.7-2.1hrs]

      Operative time was recorded from skin incision to wound closure.

    10. Blood Loss [During the time of operation, an average of 1.7-2.1 hrs]

    11. Hospital Stay [From admission to discharge, an average of 1.0-1.5 day]

    12. Rate of Secondary Surgery at Index Level [24 months]

      Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of subjects who had secondary surgeries at index level.

    13. Change of Neck Disability Index Score From Baseline [Baseline and 24 months post-operation]

      The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline.

    14. Change of Neck Pain Score From Baseline [Baseline and 24 months post-operation]

      Numerical rating scales were used to evaluate neck pain intensity and frequency. Subjects rated their neck pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their neck pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total neck pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline.

    15. Change of Arm Pain Score From Baseline [Baseline and 24 months post-operation]

      Numerical rating scales were also used to evaluate arm pain intensity and frequency. Subjects rated their arm pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their arm pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total arm pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline.

    16. Change of General Health Status -- SF-36 PCS From Baseline [Baseline and 24 months post-operation]

      The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.

    17. Change of General Health Status -- SF-36 MCS From Baseline [Baseline and 24 months post-operation]

      The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Has cervical DDD at 2 adjacent cervical levels (C3-C7) requiring surgical treatment & involving intractable radiculopathy, myelopathy, or both

    • Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history, and the requirement for surgical treatment is evidenced by radiographic studies

    • Unresponsive to non-operative treatment for approximately 6 weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management

    • Has no previous surgical intervention at the involved levels or any subsequent planned/staged surgical procedure at the involved or adjacent level(s)

    • Must be ≥ 18 years; skeletally mature at time of surgery

    • Preoperative NDI score ≥ 30

    • Preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain Questionnaire

    • If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period

    • Is willing to comply with the study plan and sign Patient Informed Consent Form

    Exclusion Criteria:

    • Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical treatment at the involved levels

    • Has documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing: Sagittal plane translation > 3.5 mm, or Sagittal plane angulation > 20 degrees.

    • Has more than two cervical levels requiring surgical treatment

    • Has a fused level adjacent to the levels to be treated

    • Has severe pathology of the facet joints of the involved vertebral bodies

    • Has had previous surgical intervention at either one or both of the involved levels or at adjacent levels

    • Has been previously diagnosed with osteopenia or osteomalacia

    • Has any of the following that may be associated with a diagnosis of osteoporosis (If "Yes" to any of the below a DEXA Scan will be required to determine eligibility.)

    • Postmenopausal non-Black female over age of 60 who weighs < 140 pounds

    • Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist fracture

    • Male > 70 years

    • Male > 60 years who has sustained a non-traumatic hip or spine fracture

    • If the level of BMD is a T score of -3.5 or lower or a T score of -2.5 or lower with vertebral crush fracture, then the patient is excluded from the study

    • Has presence of spinal metastases

    • Has overt or active bacterial infection, either local or systemic

    • Has insulin dependent diabetes

    • Is a tobacco user who does not agree to suspend smoking prior to surgery

    • Has chronic or acute renal failure or prior history of renal disease

    • Has a documented allergy or intolerance to stainless steel, titanium, or a titanium alloy

    • Is mentally incompetent (If questionable, obtain psychiatric consult)

    • Is a prisoner

    • Is pregnant

    • Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse

    • Is involved with current or pending litigation regarding a spinal condition

    • Has received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs

    • Has a history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta)

    • Has a condition that requires postoperative medications that interfere with the stability of the implant, such as steroids. (This does not include low-dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs.)

    • Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following implantation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Orthopaedic Center; Crestwood Medical Center Huntsville Alabama United States 35801
    2 Todd Lanman, MD, FACS, A Professional Corp.; Beverly Hills California United States 90210
    3 Bone & Spine Surgery Colton California United States 92324
    4 La Jolla Neurological Associates, AMC; Scripps Memorial Hospital La Jolla; Scripps Memorial Hospital Encinitas La Jolla California United States 92037
    5 St. Mary's Spine Center; St. Mary's Hospital San Francisco California United States 94117
    6 Delaware Neurosurgical Group; Christiana Care Health Systems Newark Delaware United States 19713
    7 Spinal Associates, Gulf Coast Hospital Panama City Florida United States 32405
    8 Peachtree Neurosurgery, Northside Hospital Atlanta Georgia United States 30342
    9 The Hughston Clinic, P.C., Hughston Hospital and Rehabilitation Center Columbus Georgia United States 31908
    10 Neuro Spine & Pain Center; Lutheran Hospital Fort Wayne Indiana United States 46804
    11 University of Iowa Hospitals & Clinics Iowa City Iowa United States 52242
    12 Great Lakes Neurosurgical; Spectrum Health East Campus Grand Rapids Michigan United States 49505
    13 Adams Neurosurgery; Mid Michigan Medical Center Saginaw Michigan United States 48604
    14 Henry Ford Hospital West Bloomfield Michigan United States 48322
    15 The Orthopedic Center of St. Louis; Barnes Jewish West County Hospital Chesterfield Missouri United States 63017
    16 Montana Neuro Science Institute; St. Patrick's Medical Center Missoula Montana United States 59802
    17 University at Buffalo Neurosurgery, Inc. Kaleida Health-Buffalo General Medical center/Gates Vascular Institute Buffalo New York United States 14203
    18 Buffalo Neurosurgery Group West Seneca New York United States 14224
    19 Crystal Clinic, Inc.; Akron General Medical Center Akron Ohio United States 44333
    20 Central Ohio Neurological Surgeons; Mt. Carmel East Hospital Westerville Ohio United States 43081
    21 The Center Orthopaedic & Neurosurgical Care & Research Bend Oregon United States 97701
    22 OAA Orthopaedic Specialists Allentown Pennsylvania United States 18104
    23 Allegheny Neurosurgery; Washington Hospital Pittsburgh Pennsylvania United States 15212
    24 Lexington Brain and Spine Institute West Columbia South Carolina United States 29169
    25 Center for Sports Medicine and Orthopaedics; Memorial Hospital Chattanooga Tennessee United States 37404
    26 East Tennessee Brain & Spine Center, Johnson City Medical Center Johnson City Tennessee United States 37604
    27 Central Texas Spine Institute; Health South Surgical Center Austin Texas United States 78731
    28 Virginia Brain and Spine; Winchester Medical Center Winchester Virginia United States 22601
    29 West Virginia University; Ruby Memorial Hospital, WVU Hospitals, Inc. Morgantown West Virginia United States 26506

    Sponsors and Collaborators

    • Medtronic Spinal and Biologics

    Investigators

    • Principal Investigator: John K Burkus, M.D., The Hughston Clinic, P.C.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medtronic Spinal and Biologics
    ClinicalTrials.gov Identifier:
    NCT00637156
    Other Study ID Numbers:
    • PRESTIGE LP Two Level Study
    First Posted:
    Mar 17, 2008
    Last Update Posted:
    May 1, 2018
    Last Verified:
    Oct 1, 2017
    Keywords provided by Medtronic Spinal and Biologics
    Symptomatic DDD at Two Adjacent Levels of cervical spine
    Additional relevant MeSH terms:
    Intervertebral Disc Degeneration
    Radiculopathy
    Spinal Cord Diseases

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Period Title: Overall Study
    STARTED 209 188
    COMPLETED 199 164
    NOT COMPLETED 10 24

    Baseline Characteristics

    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System Total
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System. Total of all reporting groups
    Overall Participants 209 188 397
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    47.1
    (8.3)
    47.3
    (7.7)
    47.2
    (8.0)
    Sex: Female, Male (Count of Participants)
    Female
    117
    56%
    98
    52.1%
    215
    54.2%
    Male
    92
    44%
    90
    47.9%
    182
    45.8%
    Race/Ethnicity, Customized (participants) [Number]
    Caucasian
    195
    93.3%
    172
    91.5%
    367
    92.4%
    Black
    8
    3.8%
    8
    4.3%
    16
    4%
    Asian
    1
    0.5%
    3
    1.6%
    4
    1%
    Hispanic
    4
    1.9%
    4
    2.1%
    8
    2%
    Other
    1
    0.5%
    1
    0.5%
    2
    0.5%
    Height (inches) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [inches]
    67.2
    (3.9)
    67.6
    (4.0)
    67.4
    (3.9)
    Weight (lbs) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [lbs]
    182.1
    (42.6)
    186.3
    (37.2)
    184.0
    (40.1)
    BMI (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    28.2
    (5.6)
    28.6
    (4.9)
    28.4
    (5.3)
    Marital Status (participants) [Number]
    Single
    25
    12%
    29
    15.4%
    54
    13.6%
    Married
    146
    69.9%
    133
    70.7%
    279
    70.3%
    Divorced
    32
    15.3%
    23
    12.2%
    55
    13.9%
    Separated
    4
    1.9%
    2
    1.1%
    6
    1.5%
    Widowed
    2
    1%
    1
    0.5%
    3
    0.8%
    Education Level (participants) [Number]
    <High school
    21
    10%
    20
    10.6%
    41
    10.3%
    High school
    63
    30.1%
    64
    34%
    127
    32%
    >High school
    125
    59.8%
    104
    55.3%
    229
    57.7%
    Worker's Compensation (participants) [Number]
    Yes
    26
    12.4%
    19
    10.1%
    45
    11.3%
    No
    183
    87.6%
    169
    89.9%
    352
    88.7%
    Unresolved Spinal litigation (participants) [Number]
    Yes
    0
    0%
    1
    0.5%
    1
    0.3%
    No
    209
    100%
    187
    99.5%
    396
    99.7%
    Alcohol Used (participants) [Number]
    Yes
    116
    55.5%
    88
    46.8%
    204
    51.4%
    No
    93
    44.5%
    100
    53.2%
    193
    48.6%
    Preoperative Work Status (participants) [Number]
    Yes
    146
    69.9%
    113
    60.1%
    259
    65.2%
    No
    63
    30.1%
    75
    39.9%
    138
    34.8%

    Outcome Measures

    1. Primary Outcome
    Title Rate of Overall Success
    Description Rate of overall success is reported as the percentage of participants who met all of the following criteria: Postoperative Neck Disability Index (NDI) score improvement of at least a 15-point increase from preoperative; Maintenance or improvement in neurological status; No serious adverse event classified as implant associated or implant/surgical procedure associated; and No additional surgical procedure classified as a "failure."
    Time Frame 24 Months

    Outcome Measure Data

    Analysis Population Description
    The primary analysis dataset for this study included all subjects who received study devices and completed the initial surgical procedures. The analysis was based on the observed data and missing data due to lost-to-follow-ups were imputed. For the primary endpoint, the analysis consists of 199 investigational subjects and 160 control subjects.
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Measure Participants 199 160
    Number [percentage of participants]
    81.4
    38.9%
    69.4
    36.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments The non-inferiority margin is 0.1.
    Statistical Test of Hypothesis p-Value 1.000
    Comments The posterior probability of non-inferiority was calculated and presented instead of the p-value.
    Method Bayesian model
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 0.113
    Confidence Interval (2-Sided) 95%
    0.022 to 0.201
    Parameter Dispersion Type:
    Value:
    Estimation Comments The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments Superiority comparison of overall success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated. If the posterior probability is at least 0.95, a claim of superiority can be made.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.993
    Comments The posterior probability of superiority was calculated and presented instead of the p-value.
    Method Bayesian model
    Comments
    2. Secondary Outcome
    Title Success Rate of Neck Disability Index
    Description Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met the following criterion: Pre-treatment Score - Post-treatment Score ≥ 15.
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable NDI success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Measure Participants 199 159
    Number [percentage of participants]
    87.9
    42.1%
    79.2
    42.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the NDI success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority margin is 0.1.
    Statistical Test of Hypothesis p-Value 1.000
    Comments The posterior probability of non-inferiority was calculated and presented instead of the p-value.
    Method Bayesian model
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 0.088
    Confidence Interval (2-Sided) 95%
    0.012 to 0.167
    Parameter Dispersion Type:
    Value:
    Estimation Comments The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments Superiority comparison of NDI success rates in two treatment groups was performed if non-inferiority was demonstrated.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.990
    Comments The posterior probability of superiority was calculated and presented instead of the p-value.
    Method Bayesian model
    Comments
    3. Secondary Outcome
    Title Success Rate of Neurological Status
    Description Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must either remain the same or improve from the time of the preoperative evaluation to the time period evaluated.
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neurological success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Measure Participants 199 159
    Number [percentage of participants]
    91.5
    43.8%
    86.2
    45.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the neurological success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority margin is 0.1.
    Statistical Test of Hypothesis p-Value 1.000
    Comments The posterior probability of non-inferiority was calculated and presented instead of the p-value.
    Method Bayesian model
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 0.05
    Confidence Interval (2-Sided) 95%
    -0.014 to 0.119
    Parameter Dispersion Type:
    Value:
    Estimation Comments The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments Superiority comparison of neurological success rates in two treatment groups was performed if non-inferiority was demonstrated.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.931
    Comments The posterior probability of superiority was calculated and presented instead of the p-value.
    Method Bayesian model
    Comments
    4. Secondary Outcome
    Title Neck Pain Success Rate
    Description Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0.
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neck pain success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Measure Participants 199 159
    Number [percentage of participants]
    98.0
    46.9%
    95.6
    50.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the neck pain success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority margin is 0.1.
    Statistical Test of Hypothesis p-Value 1.000
    Comments The posterior probability of non-inferiority was calculated and presented instead of the p-value.
    Method Bayesian model
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 0.021
    Confidence Interval (2-Sided) 95%
    -0.019 to 0.062
    Parameter Dispersion Type:
    Value:
    Estimation Comments The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments Superiority comparison of neck pain success rates in two treatment groups was performed if non-inferiority was demonstrated.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.852
    Comments The posterior probability of superiority was calculated and presented instead of the p-value.
    Method Bayesian model
    Comments
    5. Secondary Outcome
    Title Arm Pain Success Rate
    Description Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0.
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable arm pain success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Measure Participants 199 159
    Number [percentage of participants]
    88.9
    42.5%
    89.9
    47.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the arm pain success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority margin is 0.1.
    Statistical Test of Hypothesis p-Value 0.997
    Comments The posterior probability of non-inferiority was calculated and presented instead of the p-value.
    Method Bayesian model
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value -0.008
    Confidence Interval (2-Sided) 95%
    -0.073 to 0.056
    Parameter Dispersion Type:
    Value:
    Estimation Comments The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments Superiority comparison of arm pain success rates in two treatment groups was performed if non-inferiority was demonstrated.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.395
    Comments The posterior probability of superiority was calculated and presented instead of the p-value.
    Method Bayesian model
    Comments
    6. Secondary Outcome
    Title Success Rate of SF-36 PCS
    Description Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 PCS success status at 24 months, which leads to 197 subjects in the investigational group and 156 subjects in the control group.
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Measure Participants 197 156
    Number [percentage of participants]
    90.4
    43.3%
    87.8
    46.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the SF-36 PCS success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority margin is 0.1.
    Statistical Test of Hypothesis p-Value 1.000
    Comments The posterior probability of non-inferiority was calculated and presented instead of the p-value.
    Method Bayesian model
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 0.024
    Confidence Interval (2-Sided) 95%
    -0.042 to 0.088
    Parameter Dispersion Type:
    Value:
    Estimation Comments The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments Superiority comparison of SF-36 PCS success rates in two treatment groups was performed if non-inferiority was demonstrated.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.767
    Comments The posterior probability of superiority was calculated and presented instead of the p-value.
    Method Bayesian model
    Comments
    7. Secondary Outcome
    Title Success Rate of SF-36 MCS
    Description Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 MCS success status at 24 months, which leads to 197 subjects in the investigational group and 156 subjects in the control group.
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Measure Participants 197 156
    Number [percentage of participants]
    69.0
    33%
    72.4
    38.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the SF-36 MCS success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority margin is 0.1.
    Statistical Test of Hypothesis p-Value 0.945
    Comments The posterior probability of non-inferiority was calculated and presented instead of the p-value.
    Method Bayesian model
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value -0.024
    Confidence Interval (2-Sided) 95%
    -0.120 to 0.067
    Parameter Dispersion Type:
    Value:
    Estimation Comments The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.
    8. Secondary Outcome
    Title Rate of Disc Height Success
    Description Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height >= -2mm
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable disc height success (FSU success) status at 24 months, which leads to 170 subjects in the investigational group and 138 subjects in the control group.
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Measure Participants 170 138
    Number [percentage of participants]
    93.5
    44.7%
    95.7
    50.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the FSU success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority margin is 0.1.
    Statistical Test of Hypothesis p-Value 0.997
    Comments The posterior probability of non-inferiority was calculated and presented instead of the p-value.
    Method Bayesian model
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value -0.017
    Confidence Interval (2-Sided) 95%
    -0.072 to 0.040
    Parameter Dispersion Type:
    Value:
    Estimation Comments The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments Superiority comparison of FSU success rates in two treatment groups was performed if non-inferiority was demonstrated.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.271
    Comments The posterior probability of superiority was calculated and presented instead of the p-value.
    Method Bayesian model
    Comments
    9. Secondary Outcome
    Title Gait Success Rate
    Description Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score >= 0. The gait success rate is reported as the percentage of participants who had gait success.
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable gait success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Measure Participants 199 159
    Number [percentage of participants]
    100.0
    47.8%
    98.7
    52.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the gait success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority margin is 0.1.
    Statistical Test of Hypothesis p-Value 1.000
    Comments The posterior probability of non-inferiority was calculated and presented instead of the p-value.
    Method Bayesian model
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 0.013
    Confidence Interval (2-Sided) 95%
    -0.013 to 0.040
    Parameter Dispersion Type:
    Value:
    Estimation Comments The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments Superiority comparison of gait success rates in two treatment groups was performed if non-inferiority was demonstrated.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.859
    Comments The posterior probability of superiority was calculated and presented instead of the p-value.
    Method Bayesian model
    Comments
    10. Secondary Outcome
    Title Operative Time
    Description Operative time was recorded from skin incision to wound closure.
    Time Frame Time of operation, an average of 1.7-2.1hrs

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Measure Participants 209 188
    Mean (Standard Deviation) [hrs]
    2.1
    (0.8)
    1.7
    (0.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments Superiority comparison of the operative time in two treatment groups was assessed. The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 < 0|data) be at least 97.5%, the superiority would be claimed.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0
    Comments The posterior probably of superiority was calculated and presented instead of the p-value.
    Method Bayesian model
    Comments
    Method of Estimation Estimation Parameter Posterior Mean Difference
    Estimated Value 0.400
    Confidence Interval (2-Sided) 95%
    0.252 to 0.548
    Parameter Dispersion Type:
    Value:
    Estimation Comments The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.
    11. Secondary Outcome
    Title Blood Loss
    Description
    Time Frame During the time of operation, an average of 1.7-2.1 hrs

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Measure Participants 208 188
    Mean (Standard Deviation) [ml]
    67.2
    (64.1)
    55.7
    (46.3)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments Superiority comparison of the blood loss in two treatment groups was assessed.The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 < 0|data) be at least 97.5%, the superiority would be claimed.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments
    Method Bayesian model
    Comments
    Method of Estimation Estimation Parameter Posterior Mean Difference
    Estimated Value 11.500
    Confidence Interval (2-Sided) 95%
    0.560 to 22.440
    Parameter Dispersion Type:
    Value:
    Estimation Comments The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.
    12. Secondary Outcome
    Title Hospital Stay
    Description
    Time Frame From admission to discharge, an average of 1.0-1.5 day

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Measure Participants 209 188
    Mean (Standard Deviation) [days]
    1.2
    (0.5)
    1.3
    (1.0)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PRESTIGE LP Device, ATLANTIS Cervical Plate System
    Comments Superiority comparison of the hospital stay in two treatment groups was assessed.The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 < 0|data) be at least 97.5%, the superiority would be claimed.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.892
    Comments The posterior probably of superiority was calculated and presented instead of the p-value.
    Method Bayesian model
    Comments
    Method of Estimation Estimation Parameter Posterior Mean Difference
    Estimated Value -0.100
    Confidence Interval (2-Sided) 95%
    -0.258 to 0.058
    Parameter Dispersion Type:
    Value:
    Estimation Comments The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.
    13. Secondary Outcome
    Title Rate of Secondary Surgery at Index Level
    Description Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of subjects who had secondary surgeries at index level.
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Measure Participants 209 188
    Number [percentage of participants]
    2.4
    1.1%
    8.0
    4.3%
    14. Secondary Outcome
    Title Change of Neck Disability Index Score From Baseline
    Description The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline.
    Time Frame Baseline and 24 months post-operation

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Measure Participants 209 188
    NDI at baseline (n=209, 188)
    52.1
    (13.4)
    53.2
    (14.8)
    NDI at 24 months (n=199, 159)
    15.0
    (16.6)
    20.0
    (20.5)
    NDI change (n=199, 159)
    -37.0
    (17.8)
    -32.5
    (19.1)
    15. Secondary Outcome
    Title Change of Neck Pain Score From Baseline
    Description Numerical rating scales were used to evaluate neck pain intensity and frequency. Subjects rated their neck pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their neck pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total neck pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline.
    Time Frame Baseline and 24 months post-operation

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Measure Participants 209 188
    Neck pain at baseline (n=209, 188)
    16.2
    (2.9)
    16.3
    (2.6)
    Neck pain at 24 months (n=199, 159)
    4.3
    (4.9)
    5.9
    (5.5)
    Neck pain change (n=199, 159)
    -11.8
    (5.2)
    -10.3
    (5.1)
    16. Secondary Outcome
    Title Change of Arm Pain Score From Baseline
    Description Numerical rating scales were also used to evaluate arm pain intensity and frequency. Subjects rated their arm pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their arm pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total arm pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline.
    Time Frame Baseline and 24 months post-operation

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Measure Participants 209 188
    Arm pain at baseline (n=209, 188)
    13.8
    (5.6)
    14.4
    (4.3)
    Arm pain at 24 months (n=199, 159)
    3.0
    (4.8)
    4.0
    (5.6)
    Arm pain change (n=199, 159)
    -10.9
    (6.7)
    -10.2
    (6.5)
    17. Secondary Outcome
    Title Change of General Health Status -- SF-36 PCS From Baseline
    Description The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.
    Time Frame Baseline and 24 months post-operation

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Measure Participants 209 188
    SF-36 PCS at baseline (n=209, 188)
    31.8
    (7.8)
    30.8
    (7.4)
    SF-36 PCS at 24 months (n=197, 156)
    47.3
    (10.7)
    45.4
    (11.5)
    SF-36 PCS change (n=197, 156)
    15.3
    (11.5)
    13.8
    (11.1)
    18. Secondary Outcome
    Title Change of General Health Status -- SF-36 MCS From Baseline
    Description The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.
    Time Frame Baseline and 24 months post-operation

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    Measure Participants 209 188
    SF-36 MCS at baseline (n=209, 188)
    43.9
    (11.8)
    43.8
    (12.2)
    SF-36 MCS at 24 months (n=197, 156)
    52.1
    (10.8)
    50.9
    (10.5)
    SF-36 MCS change (n=197, 156)
    8.1
    (14.5)
    6.9
    (12.6)

    Adverse Events

    Time Frame up to 24 months
    Adverse Event Reporting Description
    Arm/Group Title PRESTIGE LP Device ATLANTIS Cervical Plate System
    Arm/Group Description PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach. Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
    All Cause Mortality
    PRESTIGE LP Device ATLANTIS Cervical Plate System
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    PRESTIGE LP Device ATLANTIS Cervical Plate System
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 72/209 (34.4%) 90/188 (47.9%)
    Blood and lymphatic system disorders
    Anaemia 0/209 (0%) 0 1/188 (0.5%) 1
    Lymphadenopathy 0/209 (0%) 0 1/188 (0.5%) 1
    Cardiac disorders
    Acute myocardial infarction 0/209 (0%) 0 1/188 (0.5%) 1
    Aortic valve incompetence 1/209 (0.5%) 1 0/188 (0%) 0
    Cardiac arrest 0/209 (0%) 0 1/188 (0.5%) 1
    Coronary artery disease 0/209 (0%) 0 1/188 (0.5%) 1
    Mitral valve incompetence 1/209 (0.5%) 1 0/188 (0%) 0
    Myocardial ischaemia 0/209 (0%) 0 1/188 (0.5%) 1
    Palpitations 1/209 (0.5%) 1 1/188 (0.5%) 1
    Sinus bradycardia 1/209 (0.5%) 1 0/188 (0%) 0
    Tachycardia 0/209 (0%) 0 1/188 (0.5%) 1
    Tricuspid valve incompetence 1/209 (0.5%) 1 0/188 (0%) 0
    Ventricular tachycardia 1/209 (0.5%) 1 0/188 (0%) 0
    Congenital, familial and genetic disorders
    Arnold-Chiari malformation 1/209 (0.5%) 1 0/188 (0%) 0
    Chronic granulomatous disease 0/209 (0%) 0 1/188 (0.5%) 1
    Myocardial bridging 1/209 (0.5%) 1 0/188 (0%) 0
    Spine malformation 1/209 (0.5%) 1 0/188 (0%) 0
    Ear and labyrinth disorders
    Vertigo 1/209 (0.5%) 1 0/188 (0%) 0
    Endocrine disorders
    Thyrotoxic crisis 1/209 (0.5%) 1 0/188 (0%) 0
    Eye disorders
    Blindness 0/209 (0%) 0 1/188 (0.5%) 1
    Cataract subcapsular 1/209 (0.5%) 1 0/188 (0%) 0
    Conjunctivitis 1/209 (0.5%) 1 0/188 (0%) 0
    Gastrointestinal disorders
    Abdominal adhesions 1/209 (0.5%) 1 0/188 (0%) 0
    Abdominal pain 4/209 (1.9%) 5 0/188 (0%) 0
    Abdominal pain lower 0/209 (0%) 0 1/188 (0.5%) 1
    Abdominal pain upper 1/209 (0.5%) 1 0/188 (0%) 0
    Anal fistula 0/209 (0%) 0 1/188 (0.5%) 1
    Constipation 1/209 (0.5%) 1 1/188 (0.5%) 1
    Diarrhoea 2/209 (1%) 2 3/188 (1.6%) 3
    Dyspepsia 0/209 (0%) 0 1/188 (0.5%) 1
    Dysphagia 2/209 (1%) 2 1/188 (0.5%) 1
    Gastritis 1/209 (0.5%) 1 0/188 (0%) 0
    Gastrooesophageal reflux disease 1/209 (0.5%) 1 2/188 (1.1%) 2
    Impaired gastric emptying 1/209 (0.5%) 1 0/188 (0%) 0
    Inguinal hernia 1/209 (0.5%) 1 1/188 (0.5%) 1
    Mesenteric occlusion 0/209 (0%) 0 1/188 (0.5%) 1
    Nausea 3/209 (1.4%) 4 7/188 (3.7%) 7
    Oesophageal disorder 1/209 (0.5%) 1 0/188 (0%) 0
    Pancreatitis 0/209 (0%) 0 1/188 (0.5%) 1
    Small intestinal obstruction 1/209 (0.5%) 1 0/188 (0%) 0
    Tooth loss 1/209 (0.5%) 1 0/188 (0%) 0
    Toothache 0/209 (0%) 0 1/188 (0.5%) 1
    Vomiting 3/209 (1.4%) 3 4/188 (2.1%) 4
    General disorders
    Abasia 0/209 (0%) 0 1/188 (0.5%) 1
    Adverse drug reaction 1/209 (0.5%) 1 2/188 (1.1%) 2
    Chest discomfort 1/209 (0.5%) 2 0/188 (0%) 0
    Chest pain 6/209 (2.9%) 6 4/188 (2.1%) 4
    Chills 0/209 (0%) 0 1/188 (0.5%) 1
    Cyst 2/209 (1%) 2 0/188 (0%) 0
    Death 0/209 (0%) 0 1/188 (0.5%) 1
    Device breakage 0/209 (0%) 0 1/188 (0.5%) 1
    Device connection issue 0/209 (0%) 0 2/188 (1.1%) 2
    Device dislocation 3/209 (1.4%) 3 4/188 (2.1%) 4
    Facial pain 0/209 (0%) 0 1/188 (0.5%) 1
    Fatigue 1/209 (0.5%) 1 0/188 (0%) 0
    Feeling abnormal 1/209 (0.5%) 1 0/188 (0%) 0
    Gait disturbance 2/209 (1%) 2 0/188 (0%) 0
    Hernia 0/209 (0%) 0 1/188 (0.5%) 1
    Pain 1/209 (0.5%) 1 4/188 (2.1%) 4
    Pyrexia 0/209 (0%) 0 2/188 (1.1%) 2
    Sensation of pressure 1/209 (0.5%) 1 0/188 (0%) 0
    Spinal pain 0/209 (0%) 0 1/188 (0.5%) 1
    Hepatobiliary disorders
    Biliary dyskinesia 1/209 (0.5%) 1 0/188 (0%) 0
    Cholecystitis 1/209 (0.5%) 1 0/188 (0%) 0
    Cholecystitis acute 1/209 (0.5%) 1 1/188 (0.5%) 1
    Cholelithiasis 2/209 (1%) 2 1/188 (0.5%) 1
    Infections and infestations
    Bronchitis 0/209 (0%) 0 2/188 (1.1%) 2
    Cellulitis 1/209 (0.5%) 1 0/188 (0%) 0
    Diverticulitis 0/209 (0%) 0 1/188 (0.5%) 1
    Enterobacter infection 1/209 (0.5%) 1 0/188 (0%) 0
    Gastroenteritis 1/209 (0.5%) 1 1/188 (0.5%) 1
    Gastroenteritis viral 0/209 (0%) 0 1/188 (0.5%) 1
    Helicobacter infection 1/209 (0.5%) 1 0/188 (0%) 0
    Lyme disease 0/209 (0%) 0 1/188 (0.5%) 1
    Perirectal abscess 0/209 (0%) 0 1/188 (0.5%) 1
    Pneumonia 1/209 (0.5%) 1 2/188 (1.1%) 2
    Pyelonephritis 0/209 (0%) 0 1/188 (0.5%) 1
    Pyelonephritis acute 0/209 (0%) 0 1/188 (0.5%) 1
    Respiratory tract infection 0/209 (0%) 0 1/188 (0.5%) 1
    Sinusitis 2/209 (1%) 3 0/188 (0%) 0
    Skin graft infection 0/209 (0%) 0 1/188 (0.5%) 1
    Urinary tract infection 2/209 (1%) 3 4/188 (2.1%) 4
    Injury, poisoning and procedural complications
    Accident 0/209 (0%) 0 1/188 (0.5%) 1
    Burns third degree 0/209 (0%) 0 1/188 (0.5%) 1
    Cartilage injury 1/209 (0.5%) 1 0/188 (0%) 0
    Concussion 0/209 (0%) 0 1/188 (0.5%) 1
    Contusion 2/209 (1%) 2 3/188 (1.6%) 4
    Corneal abrasion 1/209 (0.5%) 1 0/188 (0%) 0
    Cranial nerve injury 1/209 (0.5%) 1 0/188 (0%) 0
    Dural tear 0/209 (0%) 0 1/188 (0.5%) 1
    Excoriation 1/209 (0.5%) 3 2/188 (1.1%) 2
    Fall 7/209 (3.3%) 8 10/188 (5.3%) 11
    Flatback syndrome 0/209 (0%) 0 1/188 (0.5%) 1
    Foot fracture 1/209 (0.5%) 1 0/188 (0%) 0
    Head injury 1/209 (0.5%) 1 2/188 (1.1%) 2
    Incision site haemorrhage 1/209 (0.5%) 1 0/188 (0%) 0
    Injury 2/209 (1%) 2 0/188 (0%) 0
    Joint dislocation 0/209 (0%) 0 1/188 (0.5%) 1
    Joint injury 1/209 (0.5%) 1 2/188 (1.1%) 2
    Kyphosis postoperative 1/209 (0.5%) 1 0/188 (0%) 0
    Laceration 1/209 (0.5%) 1 4/188 (2.1%) 5
    Ligament injury 1/209 (0.5%) 1 0/188 (0%) 0
    Limb crushing injury 1/209 (0.5%) 1 0/188 (0%) 0
    Limb injury 1/209 (0.5%) 1 1/188 (0.5%) 1
    Lip injury 0/209 (0%) 0 1/188 (0.5%) 1
    Lumbar vertebral fracture 2/209 (1%) 2 0/188 (0%) 0
    Meniscus lesion 1/209 (0.5%) 1 0/188 (0%) 0
    Nail avulsion 1/209 (0.5%) 1 0/188 (0%) 0
    Open wound 1/209 (0.5%) 2 0/188 (0%) 0
    Overdose 1/209 (0.5%) 1 0/188 (0%) 0
    Patella fracture 0/209 (0%) 0 1/188 (0.5%) 1
    Pneumothorax traumatic 0/209 (0%) 0 2/188 (1.1%) 2
    Post procedural complication 1/209 (0.5%) 1 0/188 (0%) 0
    Post procedural haemorrhage 1/209 (0.5%) 1 0/188 (0%) 0
    Procedural headache 1/209 (0.5%) 1 0/188 (0%) 0
    Procedural nausea 2/209 (1%) 2 0/188 (0%) 0
    Procedural pain 1/209 (0.5%) 1 0/188 (0%) 0
    Procedural vomiting 2/209 (1%) 2 0/188 (0%) 0
    Rib fracture 1/209 (0.5%) 1 3/188 (1.6%) 5
    Road traffic accident 4/209 (1.9%) 4 9/188 (4.8%) 9
    Spinal fracture 1/209 (0.5%) 1 1/188 (0.5%) 1
    Sports injury 0/209 (0%) 0 1/188 (0.5%) 1
    Tendon injury 0/209 (0%) 0 1/188 (0.5%) 1
    Thoracic vertebral fracture 0/209 (0%) 0 1/188 (0.5%) 1
    Toxicity to various agents 0/209 (0%) 0 2/188 (1.1%) 2
    Traumatic lung injury 0/209 (0%) 0 1/188 (0.5%) 1
    Wound dehiscence 1/209 (0.5%) 1 0/188 (0%) 0
    Investigations
    Arthroscopy 0/209 (0%) 0 1/188 (0.5%) 1
    Blood glucose fluctuation 0/209 (0%) 0 1/188 (0.5%) 1
    Blood glucose increased 0/209 (0%) 0 1/188 (0.5%) 1
    Blood pressure increased 1/209 (0.5%) 2 0/188 (0%) 0
    Bone scan abnormal 0/209 (0%) 0 1/188 (0.5%) 1
    Computerised tomogram abnormal 0/209 (0%) 0 1/188 (0.5%) 1
    Drug screen positive 1/209 (0.5%) 1 0/188 (0%) 0
    Electrocardiogram abnormal 1/209 (0.5%) 1 0/188 (0%) 0
    Foetal heart rate abnormal 0/209 (0%) 0 1/188 (0.5%) 1
    Foetal monitoring 0/209 (0%) 0 1/188 (0.5%) 1
    Grip strength decreased 0/209 (0%) 0 1/188 (0.5%) 1
    Haematocrit decreased 0/209 (0%) 0 1/188 (0.5%) 1
    Liver function test abnormal 0/209 (0%) 0 1/188 (0.5%) 1
    Lymphocyte count decreased 0/209 (0%) 0 1/188 (0.5%) 1
    Neurological examination abnormal 0/209 (0%) 0 1/188 (0.5%) 1
    Nuclear magnetic resonance imaging abnormal 1/209 (0.5%) 1 0/188 (0%) 0
    Spinal X-ray abnormal 2/209 (1%) 2 1/188 (0.5%) 1
    Weight decreased 0/209 (0%) 0 1/188 (0.5%) 1
    Weight increased 1/209 (0.5%) 1 0/188 (0%) 0
    X-ray of pelvis and hip abnormal 0/209 (0%) 0 1/188 (0.5%) 1
    Metabolism and nutrition disorders
    Dehydration 0/209 (0%) 0 1/188 (0.5%) 1
    Gout 1/209 (0.5%) 1 1/188 (0.5%) 1
    Obesity 0/209 (0%) 0 1/188 (0.5%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/209 (0.5%) 1 4/188 (2.1%) 4
    Arthropathy 1/209 (0.5%) 1 2/188 (1.1%) 2
    Back pain 5/209 (2.4%) 5 5/188 (2.7%) 5
    Bursitis 1/209 (0.5%) 1 1/188 (0.5%) 1
    Cervical spinal stenosis 2/209 (1%) 2 1/188 (0.5%) 1
    Exostosis 6/209 (2.9%) 7 11/188 (5.9%) 12
    Facet joint syndrome 4/209 (1.9%) 4 10/188 (5.3%) 10
    Flank pain 1/209 (0.5%) 1 0/188 (0%) 0
    Foot deformity 1/209 (0.5%) 1 1/188 (0.5%) 1
    Groin pain 0/209 (0%) 0 1/188 (0.5%) 1
    Intervertebral disc degeneration 7/209 (3.3%) 7 10/188 (5.3%) 10
    Intervertebral disc disorder 0/209 (0%) 0 3/188 (1.6%) 3
    Intervertebral disc protrusion 11/209 (5.3%) 12 18/188 (9.6%) 20
    Intervertebral disc space narrowing 4/209 (1.9%) 4 4/188 (2.1%) 4
    Joint crepitation 0/209 (0%) 0 3/188 (1.6%) 3
    Joint range of motion decreased 0/209 (0%) 0 2/188 (1.1%) 2
    Ligament disorder 1/209 (0.5%) 1 0/188 (0%) 0
    Lumbar spinal stenosis 3/209 (1.4%) 3 7/188 (3.7%) 7
    Muscle spasms 3/209 (1.4%) 3 1/188 (0.5%) 1
    Muscular weakness 0/209 (0%) 0 2/188 (1.1%) 2
    Musculoskeletal discomfort 0/209 (0%) 0 3/188 (1.6%) 4
    Musculoskeletal disorder 0/209 (0%) 0 1/188 (0.5%) 1
    Musculoskeletal pain 5/209 (2.4%) 5 9/188 (4.8%) 11
    Musculoskeletal stiffness 0/209 (0%) 0 1/188 (0.5%) 1
    Myalgia 1/209 (0.5%) 1 1/188 (0.5%) 1
    Neck pain 4/209 (1.9%) 4 10/188 (5.3%) 10
    Osteoarthritis 4/209 (1.9%) 4 3/188 (1.6%) 3
    Pain in extremity 3/209 (1.4%) 3 11/188 (5.9%) 12
    Pain in jaw 0/209 (0%) 0 1/188 (0.5%) 1
    Periarthritis 1/209 (0.5%) 1 0/188 (0%) 0
    Polyarthritis 1/209 (0.5%) 1 0/188 (0%) 0
    Pseudarthrosis 0/209 (0%) 0 10/188 (5.3%) 10
    Rheumatoid arthritis 0/209 (0%) 0 1/188 (0.5%) 1
    Rotator cuff syndrome 4/209 (1.9%) 5 3/188 (1.6%) 4
    Scoliosis 0/209 (0%) 0 1/188 (0.5%) 1
    Spinal column stenosis 1/209 (0.5%) 1 0/188 (0%) 0
    Spinal osteoarthritis 6/209 (2.9%) 6 4/188 (2.1%) 6
    Spondylolisthesis 4/209 (1.9%) 4 4/188 (2.1%) 5
    Synovitis 0/209 (0%) 0 1/188 (0.5%) 1
    Tendonitis 1/209 (0.5%) 1 0/188 (0%) 0
    Vertebral foraminal stenosis 5/209 (2.4%) 6 8/188 (4.3%) 10
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to lung 0/209 (0%) 0 1/188 (0.5%) 1
    Pituitary tumour benign 1/209 (0.5%) 1 0/188 (0%) 0
    Thyroid neoplasm 1/209 (0.5%) 1 0/188 (0%) 0
    Tongue neoplasm malignant stage unspecified 0/209 (0%) 0 1/188 (0.5%) 1
    Uterine leiomyoma 0/209 (0%) 0 1/188 (0.5%) 1
    Nervous system disorders
    Burning sensation 0/209 (0%) 0 1/188 (0.5%) 1
    Carotid artery disease 1/209 (0.5%) 1 0/188 (0%) 0
    Carpal tunnel syndrome 3/209 (1.4%) 3 3/188 (1.6%) 3
    Cerebral atrophy 1/209 (0.5%) 1 0/188 (0%) 0
    Cerebral hypoperfusion 0/209 (0%) 0 1/188 (0.5%) 1
    Cerebrovascular accident 0/209 (0%) 0 1/188 (0.5%) 1
    Cervical cord compression 2/209 (1%) 2 1/188 (0.5%) 1
    Cervical myelopathy 1/209 (0.5%) 1 0/188 (0%) 0
    Cervicobrachial syndrome 3/209 (1.4%) 3 2/188 (1.1%) 2
    Complex regional pain syndrome 0/209 (0%) 0 1/188 (0.5%) 1
    Convulsion 1/209 (0.5%) 1 0/188 (0%) 0
    Cubital tunnel syndrome 0/209 (0%) 0 1/188 (0.5%) 1
    Dizziness 1/209 (0.5%) 1 2/188 (1.1%) 2
    Dysarthria 0/209 (0%) 0 1/188 (0.5%) 1
    Headache 5/209 (2.4%) 6 5/188 (2.7%) 5
    Hemiparesis 0/209 (0%) 0 1/188 (0.5%) 1
    Hypoaesthesia 3/209 (1.4%) 3 1/188 (0.5%) 1
    Intracranial aneurysm 0/209 (0%) 0 1/188 (0.5%) 1
    Intracranial hypotension 0/209 (0%) 0 2/188 (1.1%) 2
    Loss of consciousness 1/209 (0.5%) 1 2/188 (1.1%) 2
    Lumbar radiculopathy 1/209 (0.5%) 1 3/188 (1.6%) 3
    Migraine 1/209 (0.5%) 1 0/188 (0%) 0
    Nerve root compression 0/209 (0%) 0 2/188 (1.1%) 2
    Neuralgia 1/209 (0.5%) 1 0/188 (0%) 0
    Neuropathy peripheral 1/209 (0.5%) 1 1/188 (0.5%) 1
    Paraesthesia 0/209 (0%) 0 1/188 (0.5%) 1
    Peroneal nerve palsy 1/209 (0.5%) 1 0/188 (0%) 0
    Radicular pain 0/209 (0%) 0 2/188 (1.1%) 2
    Radiculitis brachial 0/209 (0%) 0 1/188 (0.5%) 1
    Radiculopathy 2/209 (1%) 2 0/188 (0%) 0
    Sensory loss 1/209 (0.5%) 1 1/188 (0.5%) 1
    Somnolence 0/209 (0%) 0 1/188 (0.5%) 1
    Spinal claudication 0/209 (0%) 0 1/188 (0.5%) 1
    Spinal cord compression 1/209 (0.5%) 1 1/188 (0.5%) 1
    Syncope 1/209 (0.5%) 2 2/188 (1.1%) 2
    Tongue paralysis 1/209 (0.5%) 1 0/188 (0%) 0
    Psychiatric disorders
    Aggression 0/209 (0%) 0 1/188 (0.5%) 1
    Anxiety 1/209 (0.5%) 1 1/188 (0.5%) 1
    Confusional state 1/209 (0.5%) 1 0/188 (0%) 0
    Depression 1/209 (0.5%) 1 3/188 (1.6%) 3
    Drug dependence 0/209 (0%) 0 2/188 (1.1%) 2
    Emotional distress 0/209 (0%) 0 1/188 (0.5%) 1
    Insomnia 1/209 (0.5%) 1 0/188 (0%) 0
    Panic attack 1/209 (0.5%) 1 0/188 (0%) 0
    Suicidal ideation 0/209 (0%) 0 1/188 (0.5%) 1
    Suicide attempt 0/209 (0%) 0 1/188 (0.5%) 1
    Renal and urinary disorders
    Haematuria 1/209 (0.5%) 1 0/188 (0%) 0
    Hydronephrosis 0/209 (0%) 0 1/188 (0.5%) 1
    Lower urinary tract symptoms 1/209 (0.5%) 1 0/188 (0%) 0
    Nephrolithiasis 1/209 (0.5%) 1 0/188 (0%) 0
    Renal artery stenosis 0/209 (0%) 0 1/188 (0.5%) 1
    Stress urinary incontinence 2/209 (1%) 2 0/188 (0%) 0
    Urinary retention 1/209 (0.5%) 1 1/188 (0.5%) 1
    Reproductive system and breast disorders
    Breast pain 0/209 (0%) 0 1/188 (0.5%) 1
    Haemorrhagic ovarian cyst 0/209 (0%) 0 1/188 (0.5%) 1
    Menorrhagia 0/209 (0%) 0 1/188 (0.5%) 1
    Ovarian cyst 0/209 (0%) 0 2/188 (1.1%) 2
    Pelvic pain 0/209 (0%) 0 1/188 (0.5%) 1
    Prostatitis 0/209 (0%) 0 1/188 (0.5%) 1
    Prostatomegaly 1/209 (0.5%) 1 0/188 (0%) 0
    Uterine enlargement 0/209 (0%) 0 1/188 (0.5%) 1
    Vaginal discharge 0/209 (0%) 0 1/188 (0.5%) 1
    Vaginal haemorrhage 0/209 (0%) 0 1/188 (0.5%) 1
    Respiratory, thoracic and mediastinal disorders
    Atelectasis 2/209 (1%) 2 0/188 (0%) 0
    Dyspnoea 3/209 (1.4%) 3 3/188 (1.6%) 3
    Lung infiltration 1/209 (0.5%) 1 0/188 (0%) 0
    Nasal septum deviation 1/209 (0.5%) 1 0/188 (0%) 0
    Nasal septum perforation 0/209 (0%) 0 1/188 (0.5%) 1
    Pleural effusion 0/209 (0%) 0 3/188 (1.6%) 3
    Pleural fibrosis 0/209 (0%) 0 1/188 (0.5%) 1
    Productive cough 0/209 (0%) 0 1/188 (0.5%) 1
    Pulmonary embolism 0/209 (0%) 0 1/188 (0.5%) 1
    Respiratory depression 0/209 (0%) 0 1/188 (0.5%) 1
    Sleep apnoea syndrome 0/209 (0%) 0 2/188 (1.1%) 2
    Skin and subcutaneous tissue disorders
    Hyperhidrosis 1/209 (0.5%) 1 0/188 (0%) 0
    Rash 0/209 (0%) 0 1/188 (0.5%) 1
    Telangiectasia 1/209 (0.5%) 1 0/188 (0%) 0
    Social circumstances
    Tobacco user 0/209 (0%) 0 1/188 (0.5%) 1
    Surgical and medical procedures
    Bunion operation 0/209 (0%) 0 1/188 (0.5%) 1
    Carpal tunnel decompression 0/209 (0%) 0 1/188 (0.5%) 1
    Gastric banding 1/209 (0.5%) 1 0/188 (0%) 0
    Hysterectomy 0/209 (0%) 0 1/188 (0.5%) 1
    Knee arthroplasty 1/209 (0.5%) 1 0/188 (0%) 0
    Peripheral nerve decompression 0/209 (0%) 0 1/188 (0.5%) 1
    Prolapse repair 1/209 (0.5%) 1 0/188 (0%) 0
    Rotator cuff repair 1/209 (0.5%) 1 2/188 (1.1%) 2
    Skin graft 0/209 (0%) 0 1/188 (0.5%) 1
    Spinal decompression 0/209 (0%) 0 2/188 (1.1%) 2
    Spinal fusion surgery 0/209 (0%) 0 3/188 (1.6%) 3
    Vascular stent insertion 1/209 (0.5%) 1 0/188 (0%) 0
    Vascular disorders
    Aortic aneurysm 0/209 (0%) 0 1/188 (0.5%) 1
    Aortic dissection 0/209 (0%) 0 1/188 (0.5%) 1
    Deep vein thrombosis 0/209 (0%) 0 2/188 (1.1%) 2
    Femoral artery occlusion 0/209 (0%) 0 1/188 (0.5%) 1
    Haematoma 1/209 (0.5%) 1 0/188 (0%) 0
    Hypertension 0/209 (0%) 0 1/188 (0.5%) 1
    Intermittent claudication 1/209 (0.5%) 1 1/188 (0.5%) 1
    Peripheral arterial occlusive disease 0/209 (0%) 0 1/188 (0.5%) 1
    Peripheral vascular disorder 0/209 (0%) 0 1/188 (0.5%) 1
    Other (Not Including Serious) Adverse Events
    PRESTIGE LP Device ATLANTIS Cervical Plate System
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 191/209 (91.4%) 171/188 (91%)
    Blood and lymphatic system disorders
    Anaemia 1/209 (0.5%) 1 4/188 (2.1%) 4
    Lymphadenopathy 0/209 (0%) 0 1/188 (0.5%) 1
    Microcytic anaemia 0/209 (0%) 0 1/188 (0.5%) 1
    Splenomegaly 0/209 (0%) 0 1/188 (0.5%) 2
    Cardiac disorders
    Arrhythmia 1/209 (0.5%) 1 0/188 (0%) 0
    Atrioventricular block second degree 1/209 (0.5%) 1 0/188 (0%) 0
    Bradycardia 1/209 (0.5%) 1 1/188 (0.5%) 1
    Bundle branch block left 1/209 (0.5%) 1 0/188 (0%) 0
    Palpitations 2/209 (1%) 2 2/188 (1.1%) 2
    Tachycardia 2/209 (1%) 2 0/188 (0%) 0
    Congenital, familial and genetic disorders
    Congenital choroid plexus cyst 0/209 (0%) 0 1/188 (0.5%) 1
    Spine malformation 0/209 (0%) 0 1/188 (0.5%) 1
    Ear and labyrinth disorders
    Deafness 0/209 (0%) 0 1/188 (0.5%) 1
    Ear pain 1/209 (0.5%) 1 3/188 (1.6%) 3
    Eustachian tube dysfunction 0/209 (0%) 0 1/188 (0.5%) 1
    Hypoacusis 1/209 (0.5%) 1 0/188 (0%) 0
    Meniere's disease 1/209 (0.5%) 1 0/188 (0%) 0
    Tinnitus 2/209 (1%) 2 2/188 (1.1%) 2
    Vertigo 1/209 (0.5%) 1 0/188 (0%) 0
    Vertigo positional 1/209 (0.5%) 1 0/188 (0%) 0
    Endocrine disorders
    Adrenal cyst 1/209 (0.5%) 1 0/188 (0%) 0
    Eye disorders
    Blepharospasm 0/209 (0%) 0 1/188 (0.5%) 1
    Cataract 1/209 (0.5%) 1 0/188 (0%) 0
    Conjunctival discolouration 1/209 (0.5%) 1 0/188 (0%) 0
    Conjunctivitis 1/209 (0.5%) 1 0/188 (0%) 0
    Eye swelling 0/209 (0%) 0 1/188 (0.5%) 1
    Eyelid ptosis 0/209 (0%) 0 1/188 (0.5%) 1
    Macular degeneration 0/209 (0%) 0 1/188 (0.5%) 1
    Papilloedema 1/209 (0.5%) 1 0/188 (0%) 0
    Photophobia 1/209 (0.5%) 1 1/188 (0.5%) 1
    Scintillating scotoma 0/209 (0%) 0 1/188 (0.5%) 1
    Vision blurred 0/209 (0%) 0 1/188 (0.5%) 1
    Gastrointestinal disorders
    Abdominal discomfort 3/209 (1.4%) 3 0/188 (0%) 0
    Abdominal distension 1/209 (0.5%) 1 2/188 (1.1%) 2
    Abdominal pain 2/209 (1%) 2 2/188 (1.1%) 2
    Abdominal pain lower 1/209 (0.5%) 1 1/188 (0.5%) 1
    Abdominal pain upper 1/209 (0.5%) 1 1/188 (0.5%) 1
    Acquired oesophageal web 1/209 (0.5%) 1 0/188 (0%) 0
    Cheilitis 0/209 (0%) 0 1/188 (0.5%) 1
    Colitis 1/209 (0.5%) 1 0/188 (0%) 0
    Colitis ulcerative 1/209 (0.5%) 1 0/188 (0%) 0
    Colonic polyp 2/209 (1%) 2 3/188 (1.6%) 3
    Constipation 2/209 (1%) 2 2/188 (1.1%) 2
    Dental caries 0/209 (0%) 0 1/188 (0.5%) 1
    Diarrhoea 2/209 (1%) 2 1/188 (0.5%) 1
    Diverticulum 0/209 (0%) 0 1/188 (0.5%) 1
    Dyspepsia 4/209 (1.9%) 4 2/188 (1.1%) 2
    Dysphagia 7/209 (3.3%) 7 17/188 (9%) 17
    Eructation 1/209 (0.5%) 1 0/188 (0%) 0
    Functional gastrointestinal disorder 0/209 (0%) 0 1/188 (0.5%) 1
    Gastric haemorrhage 1/209 (0.5%) 1 0/188 (0%) 0
    Gastric polyps 1/209 (0.5%) 1 0/188 (0%) 0
    Gastric ulcer 1/209 (0.5%) 1 0/188 (0%) 0
    Gastritis 3/209 (1.4%) 3 2/188 (1.1%) 2
    Gastrointestinal pain 1/209 (0.5%) 1 1/188 (0.5%) 1
    Gastrointestinal sounds abnormal 1/209 (0.5%) 1 0/188 (0%) 0
    Gastrooesophageal reflux disease 4/209 (1.9%) 4 6/188 (3.2%) 6
    Haemorrhoids 1/209 (0.5%) 1 1/188 (0.5%) 1
    Hiatus hernia 2/209 (1%) 2 0/188 (0%) 0
    Inguinal hernia 0/209 (0%) 0 1/188 (0.5%) 1
    Intestinal polyp 0/209 (0%) 0 1/188 (0.5%) 1
    Irritable bowel syndrome 1/209 (0.5%) 1 0/188 (0%) 0
    Loose tooth 1/209 (0.5%) 1 0/188 (0%) 0
    Nausea 9/209 (4.3%) 10 8/188 (4.3%) 9
    Odynophagia 1/209 (0.5%) 1 2/188 (1.1%) 2
    Oesophagitis 1/209 (0.5%) 1 1/188 (0.5%) 1
    Proctalgia 1/209 (0.5%) 1 0/188 (0%) 0
    Salivary gland mass 0/209 (0%) 0 1/188 (0.5%) 1
    Tooth erosion 0/209 (0%) 0 1/188 (0.5%) 1
    Vomiting 6/209 (2.9%) 6 3/188 (1.6%) 3
    General disorders
    Adverse drug reaction 7/209 (3.3%) 7 5/188 (2.7%) 5
    Asthenia 0/209 (0%) 0 3/188 (1.6%) 3
    Chest discomfort 6/209 (2.9%) 6 0/188 (0%) 0
    Chest pain 5/209 (2.4%) 5 3/188 (1.6%) 3
    Chills 0/209 (0%) 0 2/188 (1.1%) 2
    Complication of device insertion 1/209 (0.5%) 1 0/188 (0%) 0
    Cyst 1/209 (0.5%) 1 4/188 (2.1%) 4
    Device breakage 1/209 (0.5%) 1 1/188 (0.5%) 1
    Device connection issue 0/209 (0%) 0 1/188 (0.5%) 1
    Device deployment issue 2/209 (1%) 2 0/188 (0%) 0
    Device dislocation 5/209 (2.4%) 6 3/188 (1.6%) 3
    Face oedema 0/209 (0%) 0 1/188 (0.5%) 1
    Fatigue 3/209 (1.4%) 3 0/188 (0%) 0
    Feeling cold 0/209 (0%) 0 1/188 (0.5%) 1
    Gait disturbance 0/209 (0%) 0 1/188 (0.5%) 1
    Hernia 2/209 (1%) 2 0/188 (0%) 0
    Impaired healing 1/209 (0.5%) 1 0/188 (0%) 0
    Local swelling 0/209 (0%) 0 1/188 (0.5%) 1
    Localised oedema 0/209 (0%) 0 1/188 (0.5%) 1
    Malaise 0/209 (0%) 0 1/188 (0.5%) 1
    Medical device complication 1/209 (0.5%) 1 0/188 (0%) 0
    Medical device discomfort 1/209 (0.5%) 1 0/188 (0%) 0
    Oedema 0/209 (0%) 0 1/188 (0.5%) 1
    Oedema peripheral 3/209 (1.4%) 3 3/188 (1.6%) 3
    Pain 12/209 (5.7%) 12 7/188 (3.7%) 7
    Polyp 0/209 (0%) 0 0/188 (0%) 0
    Pyrexia 0/209 (0%) 0 7/188 (3.7%) 7
    Secretion discharge 0/209 (0%) 0 1/188 (0.5%) 1
    Sensation of foreign body 1/209 (0.5%) 1 1/188 (0.5%) 1
    Spinal pain 1/209 (0.5%) 1 2/188 (1.1%) 2
    Swelling 1/209 (0.5%) 1 0/188 (0%) 0
    Tenderness 1/209 (0.5%) 1 1/188 (0.5%) 1
    Hepatobiliary disorders
    Biliary dyskinesia 0/209 (0%) 0 1/188 (0.5%) 1
    Cholecystitis chronic 0/209 (0%) 0 1/188 (0.5%) 1
    Cholelithiasis 1/209 (0.5%) 1 0/188 (0%) 0
    Gallbladder disorder 1/209 (0.5%) 1 1/188 (0.5%) 1
    Hepatic cyst 1/209 (0.5%) 1 1/188 (0.5%) 1
    Hepatic steatosis 0/209 (0%) 0 1/188 (0.5%) 1
    Immune system disorders
    Drug hypersensitivity 0/209 (0%) 0 2/188 (1.1%) 2
    Hypersensitivity 0/209 (0%) 0 2/188 (1.1%) 2
    Seasonal allergy 1/209 (0.5%) 1 2/188 (1.1%) 2
    Infections and infestations
    Abscess limb 1/209 (0.5%) 1 0/188 (0%) 0
    Acute sinusitis 1/209 (0.5%) 1 0/188 (0%) 0
    Bacterial infection 1/209 (0.5%) 1 0/188 (0%) 0
    Bronchiolitis 0/209 (0%) 0 1/188 (0.5%) 1
    Bronchitis 2/209 (1%) 2 3/188 (1.6%) 3
    Cellulitis 1/209 (0.5%) 1 0/188 (0%) 0
    Gastroenteritis viral 2/209 (1%) 2 0/188 (0%) 0
    Gastrointestinal infection 1/209 (0.5%) 1 0/188 (0%) 0
    Helicobacter infection 1/209 (0.5%) 1 1/188 (0.5%) 1
    Herpes zoster 0/209 (0%) 0 1/188 (0.5%) 1
    Influenza 1/209 (0.5%) 1 1/188 (0.5%) 1
    Kidney infection 1/209 (0.5%) 1 0/188 (0%) 0
    Klebsiella infection 1/209 (0.5%) 1 0/188 (0%) 0
    Lower respiratory tract infection 1/209 (0.5%) 1 0/188 (0%) 0
    Nasopharyngitis 1/209 (0.5%) 1 0/188 (0%) 0
    Onychomycosis 1/209 (0.5%) 1 1/188 (0.5%) 1
    Otitis externa 1/209 (0.5%) 1 0/188 (0%) 0
    Pharyngitis streptococcal 1/209 (0.5%) 1 1/188 (0.5%) 1
    Pneumonia 2/209 (1%) 2 2/188 (1.1%) 2
    Post procedural infection 0/209 (0%) 0 1/188 (0.5%) 1
    Sinusitis 5/209 (2.4%) 5 4/188 (2.1%) 4
    Stitch abscess 1/209 (0.5%) 1 0/188 (0%) 0
    Streptococcal infection 1/209 (0.5%) 1 0/188 (0%) 0
    Tooth abscess 0/209 (0%) 0 1/188 (0.5%) 1
    Upper respiratory tract infection 2/209 (1%) 3 4/188 (2.1%) 4
    Urinary tract infection 2/209 (1%) 2 4/188 (2.1%) 4
    Viral upper respiratory tract infection 2/209 (1%) 2 0/188 (0%) 0
    Injury, poisoning and procedural complications
    Accident 1/209 (0.5%) 1 3/188 (1.6%) 3
    Accident at home 0/209 (0%) 0 1/188 (0.5%) 1
    Cartilage injury 0/209 (0%) 0 1/188 (0.5%) 1
    Cervical vertebral fracture 0/209 (0%) 0 1/188 (0.5%) 1
    Concussion 1/209 (0.5%) 1 0/188 (0%) 0
    Contusion 1/209 (0.5%) 2 1/188 (0.5%) 2
    Craniocerebral injury 1/209 (0.5%) 1 0/188 (0%) 0
    Epicondylitis 4/209 (1.9%) 4 5/188 (2.7%) 5
    Epidural fibrosis 0/209 (0%) 0 1/188 (0.5%) 1
    Excoriation 1/209 (0.5%) 1 0/188 (0%) 0
    Fall 13/209 (6.2%) 15 16/188 (8.5%) 24
    Foot fracture 0/209 (0%) 0 1/188 (0.5%) 1
    Head injury 1/209 (0.5%) 1 5/188 (2.7%) 5
    Heat exhaustion 2/209 (1%) 2 0/188 (0%) 0
    Inadequate osteointegration 0/209 (0%) 0 1/188 (0.5%) 1
    Incision site complication 1/209 (0.5%) 1 2/188 (1.1%) 2
    Incision site erythema 1/209 (0.5%) 1 2/188 (1.1%) 2
    Incision site haematoma 1/209 (0.5%) 1 0/188 (0%) 0
    Incision site hypoaesthesia 0/209 (0%) 0 1/188 (0.5%) 1
    Incision site oedema 1/209 (0.5%) 1 1/188 (0.5%) 1
    Incision site pain 2/209 (1%) 2 3/188 (1.6%) 3
    Injury 1/209 (0.5%) 1 0/188 (0%) 0
    Joint dislocation 0/209 (0%) 0 2/188 (1.1%) 2
    Joint injury 7/209 (3.3%) 7 6/188 (3.2%) 6
    Laceration 1/209 (0.5%) 1 2/188 (1.1%) 2
    Ligament injury 1/209 (0.5%) 1 0/188 (0%) 0
    Ligament rupture 0/209 (0%) 0 1/188 (0.5%) 1
    Ligament sprain 1/209 (0.5%) 1 2/188 (1.1%) 2
    Limb crushing injury 0/209 (0%) 0 1/188 (0.5%) 1
    Limb injury 1/209 (0.5%) 1 2/188 (1.1%) 2
    Meniscus lesion 1/209 (0.5%) 1 3/188 (1.6%) 3
    Muscle strain 4/209 (1.9%) 4 4/188 (2.1%) 4
    Neck injury 3/209 (1.4%) 3 0/188 (0%) 0
    Nerve injury 1/209 (0.5%) 1 1/188 (0.5%) 1
    Nerve root injury cervical 1/209 (0.5%) 1 0/188 (0%) 0
    Nerve root injury lumbar 0/209 (0%) 0 1/188 (0.5%) 1
    Nerve root injury sacral 0/209 (0%) 0 1/188 (0.5%) 1
    Periorbital haemorrhage 1/209 (0.5%) 1 0/188 (0%) 0
    Post lumbar puncture syndrome 2/209 (1%) 2 0/188 (0%) 0
    Post procedural haematoma 2/209 (1%) 2 0/188 (0%) 0
    Procedural haemorrhage 1/209 (0.5%) 1 1/188 (0.5%) 1
    Procedural headache 1/209 (0.5%) 1 0/188 (0%) 0
    Procedural hypertension 1/209 (0.5%) 1 0/188 (0%) 0
    Procedural hypotension 0/209 (0%) 0 1/188 (0.5%) 1
    Procedural nausea 3/209 (1.4%) 3 1/188 (0.5%) 1
    Procedural pain 2/209 (1%) 2 2/188 (1.1%) 2
    Procedural site reaction 0/209 (0%) 0 1/188 (0.5%) 1
    Procedural vomiting 1/209 (0.5%) 1 0/188 (0%) 0
    Repetitive strain injury 0/209 (0%) 0 1/188 (0.5%) 1
    Rib fracture 1/209 (0.5%) 1 0/188 (0%) 0
    Road traffic accident 13/209 (6.2%) 13 8/188 (4.3%) 9
    Soft tissue injury 1/209 (0.5%) 1 0/188 (0%) 0
    Sports injury 1/209 (0.5%) 1 0/188 (0%) 0
    Tendon injury 2/209 (1%) 2 2/188 (1.1%) 2
    Tendon rupture 0/209 (0%) 0 1/188 (0.5%) 1
    Ulnar nerve injury 1/209 (0.5%) 1 0/188 (0%) 0
    Urinary retention postoperative 2/209 (1%) 2 3/188 (1.6%) 3
    Wound complication 1/209 (0.5%) 1 0/188 (0%) 0
    Wound dehiscence 2/209 (1%) 2 1/188 (0.5%) 1
    Wound secretion 1/209 (0.5%) 1 0/188 (0%) 0
    Investigations
    Alanine aminotransferase increased 0/209 (0%) 0 3/188 (1.6%) 3
    Angiogram cerebral abnormal 1/209 (0.5%) 1 0/188 (0%) 0
    Aspartate aminotransferase increased 0/209 (0%) 0 2/188 (1.1%) 2
    Bacterial test positive 1/209 (0.5%) 1 0/188 (0%) 0
    Biopsy mucosa normal 1/209 (0.5%) 1 0/188 (0%) 0
    Biopsy oesophagus normal 1/209 (0.5%) 1 0/188 (0%) 0
    Blood cholesterol increased 1/209 (0.5%) 1 3/188 (1.6%) 3
    Blood cortisol decreased 1/209 (0.5%) 1 0/188 (0%) 0
    Blood creatine phosphokinase increased 1/209 (0.5%) 1 0/188 (0%) 0
    Blood glucose increased 2/209 (1%) 2 2/188 (1.1%) 2
    Blood pressure increased 3/209 (1.4%) 3 1/188 (0.5%) 1
    Blood triglycerides increased 0/209 (0%) 0 1/188 (0.5%) 1
    Bone scan abnormal 1/209 (0.5%) 1 1/188 (0.5%) 1
    Computerised tomogram abnormal 1/209 (0.5%) 1 0/188 (0%) 0
    False positive investigation result 0/209 (0%) 0 1/188 (0.5%) 1
    Glomerular filtration rate decreased 1/209 (0.5%) 1 0/188 (0%) 0
    Glycosylated haemoglobin increased 0/209 (0%) 0 1/188 (0.5%) 1
    Grip strength decreased 0/209 (0%) 0 1/188 (0.5%) 1
    Haemoglobin decreased 0/209 (0%) 0 1/188 (0.5%) 1
    Heart rate increased 1/209 (0.5%) 1 0/188 (0%) 0
    High density lipoprotein decreased 0/209 (0%) 0 1/188 (0.5%) 1
    Lasegue's test positive 0/209 (0%) 0 1/188 (0.5%) 1
    Lipids increased 0/209 (0%) 0 1/188 (0.5%) 1
    Mean cell haemoglobin 0/209 (0%) 0 1/188 (0.5%) 1
    Neurological examination 1/209 (0.5%) 1 0/188 (0%) 0
    Neurological examination abnormal 1/209 (0.5%) 1 3/188 (1.6%) 3
    Nuclear magnetic resonance imaging abnormal 0/209 (0%) 0 1/188 (0.5%) 1
    Orthopedic examination abnormal 0/209 (0%) 0 1/188 (0.5%) 1
    Oxygen saturation decreased 0/209 (0%) 0 1/188 (0.5%) 1
    Scan abnormal 1/209 (0.5%) 1 0/188 (0%) 0
    Scan bone marrow abnormal 1/209 (0.5%) 1 0/188 (0%) 0
    Sensory level abnormal 0/209 (0%) 0 1/188 (0.5%) 1
    Spinal X-ray abnormal 0/209 (0%) 0 5/188 (2.7%) 5
    Staphylococcus test positive 1/209 (0.5%) 1 0/188 (0%) 0
    Stress echocardiogram abnormal 1/209 (0.5%) 1 0/188 (0%) 0
    Urine output decreased 1/209 (0.5%) 1 0/188 (0%) 0
    Weight decreased 1/209 (0.5%) 1 2/188 (1.1%) 2
    Weight increased 0/209 (0%) 0 1/188 (0.5%) 1
    White blood cell count increased 0/209 (0%) 0 1/188 (0.5%) 1
    X-ray abnormal 0/209 (0%) 0 1/188 (0.5%) 1
    X-ray limb abnormal 1/209 (0.5%) 1 0/188 (0%) 0
    Metabolism and nutrition disorders
    Decreased appetite 1/209 (0.5%) 1 0/188 (0%) 0
    Dehydration 1/209 (0.5%) 1 0/188 (0%) 0
    Diabetes mellitus 0/209 (0%) 0 3/188 (1.6%) 3
    Electrolyte imbalance 1/209 (0.5%) 1 0/188 (0%) 0
    Fluid overload 1/209 (0.5%) 1 0/188 (0%) 0
    Hypercholesterolaemia 1/209 (0.5%) 1 0/188 (0%) 0
    Hyperglycaemia 2/209 (1%) 2 0/188 (0%) 0
    Hyperlipidaemia 1/209 (0.5%) 1 1/188 (0.5%) 1
    Hypoglycaemia 2/209 (1%) 2 0/188 (0%) 0
    Type 2 diabetes mellitus 1/209 (0.5%) 1 2/188 (1.1%) 2
    Vitamin B12 deficiency 0/209 (0%) 0 1/188 (0.5%) 1
    Vitamin C deficiency 0/209 (0%) 0 1/188 (0.5%) 1
    Vitamin D deficiency 0/209 (0%) 0 1/188 (0.5%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 18/209 (8.6%) 21 18/188 (9.6%) 20
    Arthritis 2/209 (1%) 2 1/188 (0.5%) 1
    Arthropathy 2/209 (1%) 2 0/188 (0%) 0
    Back pain 34/209 (16.3%) 37 35/188 (18.6%) 39
    Bone erosion 1/209 (0.5%) 1 0/188 (0%) 0
    Bursa disorder 0/209 (0%) 0 1/188 (0.5%) 1
    Bursitis 4/209 (1.9%) 4 2/188 (1.1%) 2
    Cervical spinal stenosis 2/209 (1%) 2 1/188 (0.5%) 1
    Cervical spine flattening 2/209 (1%) 2 0/188 (0%) 0
    Chondropathy 1/209 (0.5%) 1 0/188 (0%) 0
    Coccydynia 2/209 (1%) 2 1/188 (0.5%) 1
    Costochondritis 1/209 (0.5%) 1 0/188 (0%) 0
    Exostosis 17/209 (8.1%) 19 11/188 (5.9%) 13
    Facet joint syndrome 10/209 (4.8%) 11 10/188 (5.3%) 10
    Fibromyalgia 0/209 (0%) 0 5/188 (2.7%) 5
    Flank pain 2/209 (1%) 2 0/188 (0%) 0
    Foot deformity 1/209 (0.5%) 1 1/188 (0.5%) 1
    Groin pain 1/209 (0.5%) 1 1/188 (0.5%) 1
    Intervertebral disc degeneration 14/209 (6.7%) 14 12/188 (6.4%) 12
    Intervertebral disc disorder 1/209 (0.5%) 1 2/188 (1.1%) 3
    Intervertebral disc protrusion 12/209 (5.7%) 14 19/188 (10.1%) 24
    Intervertebral disc space narrowing 2/209 (1%) 2 3/188 (1.6%) 3
    Jaw disorder 1/209 (0.5%) 1 0/188 (0%) 0
    Joint crepitation 19/209 (9.1%) 23 5/188 (2.7%) 5
    Joint lock 3/209 (1.4%) 3 0/188 (0%) 0
    Joint range of motion decreased 6/209 (2.9%) 6 9/188 (4.8%) 9
    Joint swelling 0/209 (0%) 0 1/188 (0.5%) 1
    Kyphosis 1/209 (0.5%) 1 0/188 (0%) 0
    Limb discomfort 5/209 (2.4%) 5 3/188 (1.6%) 3
    Lumbar spinal stenosis 3/209 (1.4%) 3 2/188 (1.1%) 3
    Muscle atrophy 2/209 (1%) 2 0/188 (0%) 0
    Muscle spasms 23/209 (11%) 25 12/188 (6.4%) 16
    Muscle tightness 9/209 (4.3%) 10 6/188 (3.2%) 7
    Muscle twitching 1/209 (0.5%) 1 0/188 (0%) 0
    Muscular weakness 14/209 (6.7%) 15 8/188 (4.3%) 10
    Musculoskeletal chest pain 1/209 (0.5%) 1 2/188 (1.1%) 2
    Musculoskeletal discomfort 8/209 (3.8%) 9 8/188 (4.3%) 11
    Musculoskeletal disorder 1/209 (0.5%) 1 0/188 (0%) 0
    Musculoskeletal pain 51/209 (24.4%) 59 39/188 (20.7%) 46
    Musculoskeletal stiffness 16/209 (7.7%) 18 14/188 (7.4%) 14
    Myalgia 13/209 (6.2%) 14 6/188 (3.2%) 6
    Myofascial pain syndrome 3/209 (1.4%) 3 0/188 (0%) 0
    Myopathy 0/209 (0%) 0 1/188 (0.5%) 1
    Neck pain 64/209 (30.6%) 82 60/188 (31.9%) 77
    Osteoarthritis 6/209 (2.9%) 8 12/188 (6.4%) 17
    Osteolysis 1/209 (0.5%) 1 0/188 (0%) 0
    Osteopenia 3/209 (1.4%) 3 0/188 (0%) 0
    Pain in extremity 41/209 (19.6%) 51 50/188 (26.6%) 58
    Pain in jaw 0/209 (0%) 0 1/188 (0.5%) 1
    Patellofemoral pain syndrome 0/209 (0%) 0 1/188 (0.5%) 1
    Pathological fracture 0/209 (0%) 0 0/188 (0%) 0
    Pelvic deformity 1/209 (0.5%) 1 0/188 (0%) 0
    Periarthritis 2/209 (1%) 2 1/188 (0.5%) 1
    Plantar fasciitis 0/209 (0%) 0 1/188 (0.5%) 1
    Pseudarthrosis 0/209 (0%) 0 8/188 (4.3%) 8
    Rheumatoid arthritis 0/209 (0%) 0 1/188 (0.5%) 1
    Rotator cuff syndrome 8/209 (3.8%) 8 6/188 (3.2%) 7
    Sacroiliitis 1/209 (0.5%) 1 0/188 (0%) 0
    Scoliosis 4/209 (1.9%) 4 0/188 (0%) 0
    Sensation of heaviness 1/209 (0.5%) 1 0/188 (0%) 0
    Spinal column stenosis 0/209 (0%) 0 1/188 (0.5%) 1
    Spinal deformity 0/209 (0%) 0 1/188 (0.5%) 1
    Spinal fusion acquired 6/209 (2.9%) 6 0/188 (0%) 0
    Spinal osteoarthritis 9/209 (4.3%) 9 15/188 (8%) 16
    Spondylolisthesis 4/209 (1.9%) 4 5/188 (2.7%) 7
    Spondylolysis 0/209 (0%) 0 1/188 (0.5%) 1
    Syndesmophyte 1/209 (0.5%) 1 0/188 (0%) 0
    Synovial cyst 2/209 (1%) 2 2/188 (1.1%) 2
    Synovitis 0/209 (0%) 0 0/188 (0%) 0
    Systemic lupus erythematosus 1/209 (0.5%) 1 0/188 (0%) 0
    Temporomandibular joint syndrome 1/209 (0.5%) 1 0/188 (0%) 0
    Tendon disorder 1/209 (0.5%) 1 1/188 (0.5%) 1
    Tendonitis 1/209 (0.5%) 1 6/188 (3.2%) 7
    Tenosynovitis 0/209 (0%) 0 1/188 (0.5%) 1
    Trigger finger 1/209 (0.5%) 1 1/188 (0.5%) 1
    Trismus 0/209 (0%) 0 1/188 (0.5%) 1
    Vertebral foraminal stenosis 10/209 (4.8%) 13 12/188 (6.4%) 12
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 0/209 (0%) 0 1/188 (0.5%) 1
    Benign nipple neoplasm 0/209 (0%) 0 1/188 (0.5%) 1
    Colon adenoma 0/209 (0%) 0 1/188 (0.5%) 1
    Neurofibroma 0/209 (0%) 0 1/188 (0.5%) 1
    Pituitary tumour benign 1/209 (0.5%) 1 0/188 (0%) 0
    Pituitary tumour recurrent 1/209 (0.5%) 1 0/188 (0%) 0
    Seborrhoeic keratosis 0/209 (0%) 0 2/188 (1.1%) 2
    Skin papilloma 0/209 (0%) 0 1/188 (0.5%) 1
    Spinal haemangioma 0/209 (0%) 0 2/188 (1.1%) 2
    Thyroid neoplasm 3/209 (1.4%) 3 1/188 (0.5%) 1
    Uterine leiomyoma 1/209 (0.5%) 2 2/188 (1.1%) 2
    Nervous system disorders
    Amnesia 0/209 (0%) 0 1/188 (0.5%) 1
    Aphonia 1/209 (0.5%) 1 0/188 (0%) 0
    Areflexia 1/209 (0.5%) 1 0/188 (0%) 0
    Ataxia 0/209 (0%) 0 1/188 (0.5%) 1
    Aura 0/209 (0%) 0 1/188 (0.5%) 1
    Balance disorder 0/209 (0%) 0 1/188 (0.5%) 1
    Benign intracranial hypertension 1/209 (0.5%) 1 0/188 (0%) 0
    Brachial plexopathy 1/209 (0.5%) 1 1/188 (0.5%) 1
    Burning sensation 6/209 (2.9%) 6 3/188 (1.6%) 3
    Carotid artery disease 0/209 (0%) 0 1/188 (0.5%) 1
    Carpal tunnel syndrome 11/209 (5.3%) 11 10/188 (5.3%) 11
    Cerebral infarction 0/209 (0%) 0 1/188 (0.5%) 2
    Cerebral small vessel ischaemic disease 1/209 (0.5%) 2 1/188 (0.5%) 1
    Cervical cord compression 1/209 (0.5%) 1 0/188 (0%) 0
    Cervicobrachial syndrome 3/209 (1.4%) 3 3/188 (1.6%) 5
    Cervicogenic headache 0/209 (0%) 0 1/188 (0.5%) 1
    Cognitive disorder 0/209 (0%) 0 1/188 (0.5%) 1
    Complex regional pain syndrome 0/209 (0%) 0 1/188 (0.5%) 1
    Convulsion 2/209 (1%) 2 0/188 (0%) 0
    Cubital tunnel syndrome 1/209 (0.5%) 1 2/188 (1.1%) 2
    Demyelination 1/209 (0.5%) 1 1/188 (0.5%) 1
    Diabetic neuropathy 1/209 (0.5%) 1 0/188 (0%) 0
    Dizziness 3/209 (1.4%) 3 2/188 (1.1%) 3
    Dizziness postural 0/209 (0%) 0 1/188 (0.5%) 1
    Dysaesthesia 2/209 (1%) 2 4/188 (2.1%) 5
    Dyskinesia 0/209 (0%) 0 1/188 (0.5%) 1
    Epilepsy 0/209 (0%) 0 1/188 (0.5%) 1
    Extensor plantar response 0/209 (0%) 0 1/188 (0.5%) 1
    Gait spastic 0/209 (0%) 0 1/188 (0.5%) 1
    Head discomfort 0/209 (0%) 0 1/188 (0.5%) 1
    Head titubation 0/209 (0%) 0 0/188 (0%) 0
    Headache 31/209 (14.8%) 33 35/188 (18.6%) 44
    Hemiparesis 2/209 (1%) 2 0/188 (0%) 0
    Hyperaesthesia 0/209 (0%) 0 1/188 (0.5%) 1
    Hyperreflexia 0/209 (0%) 0 5/188 (2.7%) 5
    Hypoaesthesia 42/209 (20.1%) 55 38/188 (20.2%) 47
    Hyporeflexia 1/209 (0.5%) 1 4/188 (2.1%) 5
    Loss of consciousness 2/209 (1%) 2 1/188 (0.5%) 1
    Lumbar radiculopathy 0/209 (0%) 0 3/188 (1.6%) 3
    Migraine 2/209 (1%) 2 6/188 (3.2%) 6
    Muscle contractions involuntary 1/209 (0.5%) 1 0/188 (0%) 0
    Myelopathy 0/209 (0%) 0 1/188 (0.5%) 1
    Nerve compression 1/209 (0.5%) 1 1/188 (0.5%) 1
    Nerve root compression 1/209 (0.5%) 1 0/188 (0%) 0
    Nerve root lesion 0/209 (0%) 0 1/188 (0.5%) 1
    Neuritis 0/209 (0%) 0 2/188 (1.1%) 2
    Neurological decompensation 0/209 (0%) 0 1/188 (0.5%) 1
    Neuropathy peripheral 1/209 (0.5%) 1 2/188 (1.1%) 2
    Occipital neuralgia 0/209 (0%) 0 1/188 (0.5%) 1
    Paraesthesia 33/209 (15.8%) 42 16/188 (8.5%) 17
    Periodic limb movement disorder 0/209 (0%) 0 1/188 (0.5%) 1
    Radial nerve compression 1/209 (0.5%) 1 0/188 (0%) 0
    Radicular pain 2/209 (1%) 2 0/188 (0%) 0
    Radicular syndrome 1/209 (0.5%) 1 0/188 (0%) 0
    Radiculitis 0/209 (0%) 0 1/188 (0.5%) 1
    Radiculitis lumbosacral 0/209 (0%) 0 1/188 (0.5%) 1
    Radiculopathy 1/209 (0.5%) 1 0/188 (0%) 0
    Restless legs syndrome 0/209 (0%) 0 2/188 (1.1%) 2
    Sciatica 1/209 (0.5%) 1 3/188 (1.6%) 3
    Sensory disturbance 3/209 (1.4%) 4 2/188 (1.1%) 2
    Sensory loss 6/209 (2.9%) 6 6/188 (3.2%) 6
    Somnolence 0/209 (0%) 0 1/188 (0.5%) 1
    Syncope 3/209 (1.4%) 5 0/188 (0%) 0
    Syringomyelia 1/209 (0.5%) 1 1/188 (0.5%) 1
    Tinel's sign 1/209 (0.5%) 1 0/188 (0%) 0
    Transient ischaemic attack 1/209 (0.5%) 1 0/188 (0%) 0
    Tremor 1/209 (0.5%) 1 0/188 (0%) 0
    Vocal cord paralysis 2/209 (1%) 2 0/188 (0%) 0
    Vocal cord paresis 0/209 (0%) 0 1/188 (0.5%) 1
    Psychiatric disorders
    Affective disorder 0/209 (0%) 0 1/188 (0.5%) 1
    Anxiety 3/209 (1.4%) 3 3/188 (1.6%) 3
    Anxiety disorder 0/209 (0%) 0 1/188 (0.5%) 1
    Depression 4/209 (1.9%) 4 4/188 (2.1%) 4
    Disorientation 1/209 (0.5%) 1 1/188 (0.5%) 1
    Drug dependence 3/209 (1.4%) 3 0/188 (0%) 0
    Emotional distress 0/209 (0%) 0 1/188 (0.5%) 1
    Hallucination 1/209 (0.5%) 1 0/188 (0%) 0
    Initial insomnia 0/209 (0%) 0 1/188 (0.5%) 1
    Insomnia 6/209 (2.9%) 7 1/188 (0.5%) 1
    Mental status changes 1/209 (0.5%) 1 1/188 (0.5%) 1
    Panic attack 1/209 (0.5%) 1 0/188 (0%) 0
    Post-traumatic stress disorder 1/209 (0.5%) 1 0/188 (0%) 0
    Psychosomatic disease 0/209 (0%) 0 1/188 (0.5%) 1
    Psychotic disorder 0/209 (0%) 0 1/188 (0.5%) 1
    Somatoform disorder 0/209 (0%) 0 1/188 (0.5%) 1
    Stress 1/209 (0.5%) 1 0/188 (0%) 0
    Tension 1/209 (0.5%) 1 0/188 (0%) 0
    Renal and urinary disorders
    Bladder dysfunction 0/209 (0%) 0 1/188 (0.5%) 1
    Calculus bladder 1/209 (0.5%) 1 0/188 (0%) 0
    Cystitis interstitial 1/209 (0.5%) 1 0/188 (0%) 0
    Dysuria 1/209 (0.5%) 1 1/188 (0.5%) 1
    Haematuria 1/209 (0.5%) 1 2/188 (1.1%) 2
    Micturition urgency 1/209 (0.5%) 1 0/188 (0%) 0
    Nephrolithiasis 0/209 (0%) 0 1/188 (0.5%) 1
    Pollakiuria 0/209 (0%) 0 1/188 (0.5%) 1
    Renal cyst 2/209 (1%) 2 0/188 (0%) 0
    Renal disorder 1/209 (0.5%) 1 0/188 (0%) 0
    Renal failure chronic 0/209 (0%) 0 1/188 (0.5%) 1
    Urethral stenosis 0/209 (0%) 0 1/188 (0.5%) 1
    Urinary retention 1/209 (0.5%) 1 1/188 (0.5%) 1
    Reproductive system and breast disorders
    Breast cyst 1/209 (0.5%) 1 0/188 (0%) 0
    Breast discharge 0/209 (0%) 0 1/188 (0.5%) 1
    Breast fibrosis 0/209 (0%) 0 1/188 (0.5%) 1
    Breast mass 0/209 (0%) 0 2/188 (1.1%) 2
    Breast pain 0/209 (0%) 0 2/188 (1.1%) 2
    Breast tenderness 0/209 (0%) 0 1/188 (0.5%) 1
    Cervical dysplasia 1/209 (0.5%) 1 0/188 (0%) 0
    Endometriosis 1/209 (0.5%) 1 0/188 (0%) 0
    Menopausal symptoms 0/209 (0%) 0 1/188 (0.5%) 1
    Menorrhagia 0/209 (0%) 0 2/188 (1.1%) 2
    Menstrual disorder 0/209 (0%) 0 1/188 (0.5%) 1
    Ovarian cyst 2/209 (1%) 2 3/188 (1.6%) 3
    Ovarian mass 0/209 (0%) 0 1/188 (0.5%) 1
    Prostatomegaly 0/209 (0%) 0 1/188 (0.5%) 1
    Testicular pain 1/209 (0.5%) 2 0/188 (0%) 0
    Varicocele 0/209 (0%) 0 1/188 (0.5%) 1
    Vulvovaginal burning sensation 1/209 (0.5%) 1 0/188 (0%) 0
    Vulvovaginal pruritus 1/209 (0.5%) 1 0/188 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema 1/209 (0.5%) 1 0/188 (0%) 0
    Acute respiratory failure 1/209 (0.5%) 1 0/188 (0%) 0
    Apnoeic attack 0/209 (0%) 0 1/188 (0.5%) 1
    Asthma 0/209 (0%) 0 2/188 (1.1%) 2
    Atelectasis 2/209 (1%) 2 3/188 (1.6%) 4
    Cough 9/209 (4.3%) 10 2/188 (1.1%) 2
    Dysphonia 3/209 (1.4%) 3 5/188 (2.7%) 5
    Dyspnoea 4/209 (1.9%) 4 3/188 (1.6%) 3
    Dyspnoea exertional 1/209 (0.5%) 1 1/188 (0.5%) 1
    Epistaxis 1/209 (0.5%) 1 0/188 (0%) 0
    Haemoptysis 1/209 (0.5%) 1 0/188 (0%) 0
    Hypoxia 1/209 (0.5%) 1 1/188 (0.5%) 1
    Laryngospasm 0/209 (0%) 0 1/188 (0.5%) 1
    Lung infiltration 1/209 (0.5%) 1 0/188 (0%) 0
    Nasal congestion 3/209 (1.4%) 3 0/188 (0%) 0
    Nasal discomfort 1/209 (0.5%) 1 0/188 (0%) 0
    Oropharyngeal pain 4/209 (1.9%) 4 5/188 (2.7%) 6
    Painful respiration 2/209 (1%) 2 0/188 (0%) 0
    Pharyngeal erythema 1/209 (0.5%) 1 0/188 (0%) 0
    Pharyngeal mass 0/209 (0%) 0 1/188 (0.5%) 1
    Productive cough 1/209 (0.5%) 1 0/188 (0%) 0
    Reflux laryngitis 0/209 (0%) 0 1/188 (0.5%) 1
    Respiratory tract congestion 2/209 (1%) 2 1/188 (0.5%) 1
    Rhinitis seasonal 0/209 (0%) 0 2/188 (1.1%) 2
    Rhinorrhoea 1/209 (0.5%) 1 0/188 (0%) 0
    Sinus congestion 1/209 (0.5%) 1 1/188 (0.5%) 1
    Sinus disorder 0/209 (0%) 0 3/188 (1.6%) 3
    Sleep apnoea syndrome 1/209 (0.5%) 1 5/188 (2.7%) 6
    Snoring 0/209 (0%) 0 1/188 (0.5%) 1
    Throat tightness 1/209 (0.5%) 1 2/188 (1.1%) 2
    Wheezing 2/209 (1%) 2 0/188 (0%) 0
    Skin and subcutaneous tissue disorders
    Acne 0/209 (0%) 0 1/188 (0.5%) 1
    Actinic keratosis 0/209 (0%) 0 1/188 (0.5%) 1
    Blister 0/209 (0%) 0 1/188 (0.5%) 1
    Dermal cyst 2/209 (1%) 2 0/188 (0%) 0
    Dermatitis contact 3/209 (1.4%) 3 0/188 (0%) 0
    Erythema 0/209 (0%) 0 3/188 (1.6%) 3
    Hyperhidrosis 0/209 (0%) 0 1/188 (0.5%) 1
    Ingrowing nail 0/209 (0%) 0 1/188 (0.5%) 3
    Ingrown hair 1/209 (0.5%) 1 1/188 (0.5%) 1
    Lentigo 0/209 (0%) 0 1/188 (0.5%) 1
    Pruritus 1/209 (0.5%) 1 1/188 (0.5%) 1
    Psoriasis 1/209 (0.5%) 1 0/188 (0%) 0
    Rash 5/209 (2.4%) 7 5/188 (2.7%) 6
    Scar 0/209 (0%) 0 1/188 (0.5%) 1
    Sebaceous gland disorder 0/209 (0%) 0 1/188 (0.5%) 1
    Skin lesion 0/209 (0%) 0 1/188 (0.5%) 1
    Skin reaction 1/209 (0.5%) 1 0/188 (0%) 0
    Swelling face 1/209 (0.5%) 1 0/188 (0%) 0
    Urticaria 0/209 (0%) 0 1/188 (0.5%) 1
    Surgical and medical procedures
    Canalith repositioning procedure 1/209 (0.5%) 1 0/188 (0%) 0
    Colon polypectomy 0/209 (0%) 0 0/188 (0%) 0
    Sinus operation 0/209 (0%) 0 1/188 (0.5%) 1
    Tooth extraction 0/209 (0%) 0 1/188 (0.5%) 1
    Urostomy 1/209 (0.5%) 1 0/188 (0%) 0
    Vascular disorders
    Haematoma 1/209 (0.5%) 1 0/188 (0%) 0
    Haemorrhage 0/209 (0%) 0 1/188 (0.5%) 1
    Hot flush 0/209 (0%) 0 1/188 (0.5%) 2
    Hypertension 7/209 (3.3%) 7 5/188 (2.7%) 5
    Lymphoedema 1/209 (0.5%) 1 0/188 (0%) 0
    Orthostatic hypotension 1/209 (0.5%) 1 0/188 (0%) 0
    Peripheral coldness 0/209 (0%) 0 1/188 (0.5%) 1
    Varicose vein 0/209 (0%) 0 2/188 (1.1%) 2
    Vasodilatation 0/209 (0%) 0 1/188 (0.5%) 1
    Venous insufficiency 1/209 (0.5%) 1 0/188 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Clinical Department
    Organization Medtronic Spine and biologics
    Phone 1800-876-3133 ext 6068
    Email msbkclinicalresearch@medtronic.com
    Responsible Party:
    Medtronic Spinal and Biologics
    ClinicalTrials.gov Identifier:
    NCT00637156
    Other Study ID Numbers:
    • PRESTIGE LP Two Level Study
    First Posted:
    Mar 17, 2008
    Last Update Posted:
    May 1, 2018
    Last Verified:
    Oct 1, 2017