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RAVINE: Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine

Sponsor
K2M, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT02068729
Collaborator
(none)
131
Enrollment
68.9
Duration (Months)

Study Details

Study Description

Brief Summary

An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results for the NuVasive XLIF® system (XLIF) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results for the NuVasive XLIF® system (XLIF) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at L2-S1 requiring surgical intervention at one or two contiguous levels. Safety will be assessed by the following: 1.) Evaluation of all adverse events including device related, procedure related and additional serious adverse events; 2.) Additional surgical intervention at the operative site including the need for removals, revisions, re-operations or supplemental fixation required to modify the device; and 3.) The incidence and severity of any psoas muscle injury, genital femoral nerve injury and lumbar plexus injury will be determined for all patients. Supplemental fixation of any kind may be included as long as the procedure is completed via a minimally invasive approach.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    131 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine: K2M RAVINE® Far Lateral System Versus NuVasive XLIF®
    Study Start Date :
    Jun 1, 2014
    Actual Primary Completion Date :
    Sep 11, 2019
    Actual Study Completion Date :
    Feb 28, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Visual Analog Scale (VAS) Change From Baseline [24 months]

      Evaluation of the change of the Back VAS, Hip VAS and the Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms were captured and evaluated. VAS scale ranged from 0 - 10cm with the 10cm accounting for the highest level of pain.

    2. Number of Patients With Adverse Events AEs) [Operative to 24 month]

      The evaluation of all adverse events including device related, procedure related and additional serious adverse events.

    Secondary Outcome Measures

    1. Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) [time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months]

      Neurological evaluation of the patient, with specific evaluation of psoas muscle weakness, radiating radicular pain, knee extension weakness, dorsiflexion weakness, plantarflexion weakness and anterior thigh numbness was performed using Patient symptom Questionnaire (0-100mm analog scale with 100mm being the highest pain/weakness/numbness)

    2. Change in Oswestry Disability Index From Baseline (Pre-Operative) [time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months]

      The Oswestry Disability Index (ODI) is a validated instrument including items that relate to subjective symptomatology and activities of daily living (pain intensity, personal care, lifting, walking, sitting, standing, sex life, traveling). This patient-reported outcome measure is a 10 item questionnaire that evaluates disability and functional impairment associated with back problems. Each item is scored from O up to 5, with higher scores corresponding to greater disability. A total ODI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage. Therefore, the ODI score ranges from 0% to 100%.

    3. Change in Health-Related Quality of Life From Baseline (Pre-op) [time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months]

      Health-related quality of life was evaluated in all study subjects using the SF-12v2 Health Survey. This shortened and simplified version of the SF-36 makes the questionnaire less ambiguous for patients. It has a self-administered form that makes it easy to read and complete, and that reduces missing responses. The physical and mental component summary scales, referred to as PCS-12 and MCS-12 were evaluated against published normative values and a 15% improvement in these scores was used as an assessment of success. In calculating the true value of a treatment, the scores from the SF-12v2 were converted into a utility index (SF-6D), which considered not only how many years a medical intervention could have added to a patient's life, but also the quality of that life. Use of the SF-6D did not expand the questions administered to the patients. The scale ranged from 0-100% with 100% being the best quality of life.

    4. Radiographic Assessments [12 mo to 24 mo]

      Quantitative and qualitative radiographic assessment of the pre and post-operative AP, and Lateral, Flexion/Extension images were performed. Radiographic and qualitative assessments performed include: Device Condition: looks at both the cage inside the vertebrae and the hardware outside the vertebrae. It looks at whether or not the device is intact or not (subsidence or migration) Fusion/Non-fusion: whether bone has grown within the space between the spinal vertebrae. If fusion occurs, it results in Bony Bridging

    5. Patient Satisfaction [12 month and 24 month]

      At the 12 month and 24 month follow-up visits, subjects were asked whether they were satisfied with the outcome of their surgery (Yes/No) and whether they would repeat the operation (Yes/No).

    6. Odom's Criteria [24 months]

      At the 24 month follow-up visit, the Investigator rated the clinical disposition of each study subject according to Odom's Criteria as follows: Excellent: all pre-operative symptoms relieved, able to carry out daily occupations without impairment. Good: minimum persistence of pre-operative symptoms, able to carry out daily occupations without significant interference. Fair/Satisfactory: relief of some pre-operative symptoms but physical activity is significantly limited. Poor: symptoms or signs unchanged or worse.

    7. Surgery Time [During operation.]

      The length of the surgical procedure from the initial incision to final closure were captured from the Anesthesia Record.

    8. Anesthesia Time [During operation.]

      The length of time the patient is under anesthesia were captured from the Anesthesia Record.

    9. Estimated Blood Loss [During Operation]

      The amount of blood loss over the entire length of the surgery, documented on the Anesthesia Record, was captured.

    10. Number of Participants With Abnormal Neuromonitoring System Results [During operation]

      Abnormal result(s) of neuromonitoring systems (Train of Four, Electromyography (EMG), Triggered EMG, Somato Sensory Evoked Potential (SSEP) and Motor Evoked Potential (MEP)) utilized during the surgery were captured.

    11. Length of Hospital Stay [From admission to discharge]

      The length of hospital stay from the date of hospital admission to the date of discharge was calculated.

    12. Change in Work/School Status Compared to Baseline [Pre-operative to 24 months]

      The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented.

    13. Change in Use of Narcotics Post-Surgery Compared to Baseline [Pre-operative to 24 months]

      The types and dosages of any narcotics taken by the patient post-surgery were documented.

    Eligibility Criteria

    Criteria

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

    • Diagnosis of DDD with up to Grade 1 spondylolisthesis, confirmed clinically and radiographically, requiring surgical intervention at one or two contiguous levels between L2-S1

    • Inadequate response to conservative medical care over a period of at least 6 months

    • Willing and able to comply with the requirements of the protocol including follow-up requirements

    • Willing and able to sign a study specific informed consent

    • Skeletally mature and ≥ 18 years of age at the time of enrollment

    Exclusion Criteria:

    • Previous anterior/posterior/lateral spine surgery at the index level

    • Previous posterior/lateral spine surgery (e.g., posterior element decompression) that destabilizes the lumbar spine

    • Active systemic infection or infection at the operative site

    • Co-morbid medical conditions of the spine or upper/lower extremities that may affect the lumbar spine neurological and/or pain assessment

    • Metabolic bone disease such as osteoporosis that contradicts spinal surgery

    • History of an osteoporotic fracture

    • History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism

    • Taking medications that may interfere with bony/soft tissue healing including chronic steroid use

    • Known allergy to titanium, cobalt chrome or PEEK

    • Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia

    • Current medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion

    • Pregnant, or intend to become pregnant, during the course of the study

    • Severe obesity (Body Mass Index > 40)

    • Physical or mental condition (e.g., psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain or quality of life

    • Involved in current or pending spinal litigation where permanent disability benefits are being sought

    • Incarcerated at the time of study enrollment

    • Current participation in an investigational study that may impact study outcomes

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • K2M, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    K2M, Inc.
    ClinicalTrials.gov Identifier:
    NCT02068729
    Other Study ID Numbers:
    • CA-002
    First Posted:
    Feb 21, 2014
    Last Update Posted:
    Apr 5, 2021
    Last Verified:
    Apr 1, 2021
    Keywords provided by K2M, Inc.
    degenerative disc disease
    DDD
    Grade 1 spondylolisthesis
    spondylolisthesis
    L2-S1
    Additional relevant MeSH terms:
    Intervertebral Disc Degeneration
    Spondylolisthesis

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title K2M RAVINE Lateral Access System
    Arm/Group Description This treatment group included patients treated with the RAVINE system that had: A diagnosis of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at L2-S1, confirmed clinically and radiographically, required surgical intervention. One or two contiguous levels that required surgical intervention. Inadequately responded to conservative medical care over a period of at least 6 months. An age at time of enrollment greater or equal to 18 years old.
    Period Title: Overall Study
    STARTED 131
    COMPLETED 56
    NOT COMPLETED 75

    Baseline Characteristics

    Arm/Group Title Demographics and Baseline Characteristics
    Arm/Group Description This is a demographic and baseline characteristics of the patient population. This includes parameters such as Age, Gender, Height, Weight Body Mass Index (BMI) and Tobacco Usage.
    Overall Participants 125
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    77
    61.6%
    >=65 years
    48
    38.4%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    61.8
    (9.7)
    Sex: Female, Male (Count of Participants)
    Female
    78
    62.4%
    Male
    47
    37.6%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    0
    0%
    White
    0
    0%
    More than one race
    0
    0%
    Unknown or Not Reported
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    125
    100%
    Body Mass Index (BMI) (lbs/(in^2)*703) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [lbs/(in^2)*703]
    28.48
    (4.4)
    Height (inches) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [inches]
    65.96
    (3.9)
    Weight (pounds) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [pounds]
    177.2
    (36.7)
    Tobacco Use (Count of Participants)
    Never
    63
    50.4%
    Quit
    43
    34.4%
    Currently Use
    19
    15.2%
    Missing
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Visual Analog Scale (VAS) Change From Baseline
    Description Evaluation of the change of the Back VAS, Hip VAS and the Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms were captured and evaluated. VAS scale ranged from 0 - 10cm with the 10cm accounting for the highest level of pain.
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    All patients were accounted for
    Arm/Group Title Back Left Hip Right Hip Left Leg Right Leg
    Arm/Group Description Evaluation of the improvement of the Back VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated. Evaluation of the improvement of the Left Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated. Evaluation of the improvement of the Right Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated. Evaluation of the improvement of the Left Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated. Evaluation of the improvement of the Right Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.
    Measure Participants 56 56 56 56 56
    Mean (Standard Deviation) [score on a scale]
    -4.3
    (3.7)
    -2.3
    (3.8)
    -4.0
    (3.7)
    -2.1
    (3.4)
    -3.5
    (4)
    2. Primary Outcome
    Title Number of Patients With Adverse Events AEs)
    Description The evaluation of all adverse events including device related, procedure related and additional serious adverse events.
    Time Frame Operative to 24 month

    Outcome Measure Data

    Analysis Population Description
    This is an analysis of the number of participants that reported any form of adverse event. Participants were evaluated for all adverse events including device related, procedure related, and additional serious adverse events. 9 of the 30 SAE participants did not experience a non-SAE events. The other 21 participants had events in both categories
    Arm/Group Title Up to Post-Operative Post-Operative to 3 Months 3 to 6 Months 6 to 12 Months 12 to 24+ Months Overall
    Arm/Group Description Number of Patients with Adverse Events up to Post-Operative Number of Patients with Adverse Events Post-Operative to 3 Months Number of Patients with Adverse Events 3 to 6 Months Number of Patients with Adverse Events 6 to 12 Months Number of Patients with Adverse Events 12 to 24+ Months Overall number of Patients with Adverse Events
    Measure Participants 125 125 125 125 125 125
    Any AE
    45
    36%
    16
    NaN
    22
    NaN
    33
    NaN
    23
    NaN
    82
    NaN
    Any AE : Procedure Related
    23
    18.4%
    3
    NaN
    4
    NaN
    6
    NaN
    4
    NaN
    34
    NaN
    Any AE : Device Related
    4
    3.2%
    2
    NaN
    3
    NaN
    2
    NaN
    2
    NaN
    10
    NaN
    Any AE : Mild
    28
    22.4%
    7
    NaN
    7
    NaN
    19
    NaN
    9
    NaN
    51
    NaN
    Any AE : Moderate
    21
    16.8%
    7
    NaN
    15
    NaN
    12
    NaN
    14
    NaN
    52
    NaN
    Any AE : Severe
    5
    4%
    4
    NaN
    3
    NaN
    5
    NaN
    6
    NaN
    20
    NaN
    Any Serious Adverse Event (SAE)
    10
    8%
    4
    NaN
    3
    NaN
    7
    NaN
    10
    NaN
    30
    NaN
    Any SAE : Procedure Related
    4
    3.2%
    0
    NaN
    0
    NaN
    1
    NaN
    1
    NaN
    6
    NaN
    Any SAE : Device Related
    1
    0.8%
    1
    NaN
    0
    NaN
    0
    NaN
    1
    NaN
    2
    NaN
    Any SAE : Mild
    3
    2.4%
    0
    NaN
    0
    NaN
    1
    NaN
    2
    NaN
    6
    NaN
    Any SAE : Moderate
    4
    3.2%
    1
    NaN
    1
    NaN
    1
    NaN
    3
    NaN
    10
    NaN
    Any SAE : Severe
    5
    4%
    3
    NaN
    2
    NaN
    5
    NaN
    6
    NaN
    18
    NaN
    3. Secondary Outcome
    Title Change in Pain/Dysesthesia Score From Baseline (Pre-Operative)
    Description Neurological evaluation of the patient, with specific evaluation of psoas muscle weakness, radiating radicular pain, knee extension weakness, dorsiflexion weakness, plantarflexion weakness and anterior thigh numbness was performed using Patient symptom Questionnaire (0-100mm analog scale with 100mm being the highest pain/weakness/numbness)
    Time Frame time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months

    Outcome Measure Data

    Analysis Population Description
    The overall number of patients participated in each interval differed from the number of patients that were evaluated for the body location measurements.
    Arm/Group Title Discharge Post-Operative 3 Months 6 Months 12 Months 24 Months
    Arm/Group Description Neurological evaluation of the patient, with specific evaluation of psoas muscle weakness, radiating radicular pain, knee extension weakness, dorsiflexion weakness, plantarflexion weakness and anterior thigh numbness Neurological evaluation of the patient, with specific evaluation of psoas muscle weakness, radiating radicular pain, knee extension weakness, dorsiflexion weakness, plantarflexion weakness and anterior thigh numbness Neurological evaluation of the patient, with specific evaluation of psoas muscle weakness, radiating radicular pain, knee extension weakness, dorsiflexion weakness, plantarflexion weakness and anterior thigh numbness Neurological evaluation of the patient, with specific evaluation of psoas muscle weakness, radiating radicular pain, knee extension weakness, dorsiflexion weakness, plantarflexion weakness and anterior thigh numbness Neurological evaluation of the patient, with specific evaluation of psoas muscle weakness, radiating radicular pain, knee extension weakness, dorsiflexion weakness, plantarflexion weakness and anterior thigh numbness Neurological evaluation of the patient, with specific evaluation of psoas muscle weakness, radiating radicular pain, knee extension weakness, dorsiflexion weakness, plantarflexion weakness and anterior thigh numbness
    Measure Participants 92 117 107 103 93 56
    Pain Above Left Knee
    -3.9
    (28.6)
    -14.3
    (38.2)
    -20
    (34.3)
    -18.7
    (33.8)
    -22.4
    (34.6)
    -17.8
    (34)
    Pain Above Right Knee
    -15.3
    (33.8)
    -21.3
    (35.8)
    -26.9
    (33.9)
    -29.2
    (33.9)
    -31
    (31.4)
    -31.2
    (31.8)
    Left Groin Pain
    -0.3
    (28.3)
    -10.4
    (33.5)
    -11.8
    (30.8)
    -14.5
    (28.7)
    -15.1
    (31.1)
    -10.8
    (25.2)
    Right Groin Pain
    -7.2
    (29.9)
    -15.1
    (33.4)
    -15.7
    (31.6)
    -19.9
    (33.1)
    -20.3
    (31)
    -23.2
    (30.5)
    Flexing Left Hip Weakness
    7.8
    (37.9)
    -10.6
    (39.7)
    -15.1
    (33.3)
    -17.8
    (33.2)
    -20.0
    (32.2)
    -12.5
    (29.2)
    Flexing Right Hip Weakness
    -0.3
    (34.1)
    -17.3
    (34.7)
    -17.6
    (34.0)
    -23.5
    (33.8)
    -24.7
    (31.7)
    -20.4
    (34.1)
    Extending Left Hip Weakness
    8.6
    (39.7)
    -7.4
    (40.1)
    -14.0
    (30.1)
    -16.9
    (30.7)
    -16.8
    (33.4)
    -11.0
    (30.6)
    Extending Right Hip Weakness
    -2.8
    (33.1)
    -15.6
    (36.2)
    -16.2
    (36.5)
    -24.4
    (32.3)
    -24.4
    (33.1)
    -22.4
    (34.9)
    Left Hip Stairs Weakness
    6.1
    (38)
    -15.9
    (42.5)
    -20.5
    (38.9)
    -24.7
    (36.8)
    -26.8
    (36.6)
    -20.0
    (33.7)
    Right Hip Stairs Weakness
    0.4
    (36.2)
    -20.7
    (39.6)
    -24.3
    (37.7)
    -29.7
    (36.4)
    -30.1
    (35.2)
    -27.8
    (35.5)
    Left Hip Cross Leg Weakness
    16.8
    (41.1)
    -8.2
    (42.7)
    -16.7
    (40.1)
    -21.0
    (34.7)
    -25.5
    (36.3)
    -19.2
    (31.8)
    Right Hip Cross Leg Weakness
    6.1
    (37.1)
    -13.4
    (39.0)
    -21.6
    (36.5)
    -25.2
    (35.8)
    -27.8
    (32.4)
    -25.6
    (32.8)
    4. Secondary Outcome
    Title Change in Oswestry Disability Index From Baseline (Pre-Operative)
    Description The Oswestry Disability Index (ODI) is a validated instrument including items that relate to subjective symptomatology and activities of daily living (pain intensity, personal care, lifting, walking, sitting, standing, sex life, traveling). This patient-reported outcome measure is a 10 item questionnaire that evaluates disability and functional impairment associated with back problems. Each item is scored from O up to 5, with higher scores corresponding to greater disability. A total ODI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage. Therefore, the ODI score ranges from 0% to 100%.
    Time Frame time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months

    Outcome Measure Data

    Analysis Population Description
    131 patients started the study at Pre-op, 6 patients did not complete the survey; 125 started operative, 34 patients did not complete the survey at Discharge; 121 started the Post-operative interval, 4 patients did not complete the survey; 111 patients started at 3 Month interval, 4 patients did not complete the survey; All patients who started at 6 months and 24 months completed their surveys at their respective intervals.
    Arm/Group Title Discharge Post-Operative 3 Months 6 Months 12 Months 24 Months
    Arm/Group Description Change in Oswestry Disability Index Change in Oswestry Disability Index Change in Oswestry Disability Index Change in Oswestry Disability Index Change in Oswestry Disability Index Change in Oswestry Disability Index
    Measure Participants 91 117 107 104 93 56
    Mean (Standard Deviation) [score on a scale]
    7.7
    (19.5)
    -10.1
    (21.1)
    -17.3
    (18.5)
    -22.7
    (19)
    -26.9
    (17.5)
    -24.3
    (17.6)
    5. Secondary Outcome
    Title Change in Health-Related Quality of Life From Baseline (Pre-op)
    Description Health-related quality of life was evaluated in all study subjects using the SF-12v2 Health Survey. This shortened and simplified version of the SF-36 makes the questionnaire less ambiguous for patients. It has a self-administered form that makes it easy to read and complete, and that reduces missing responses. The physical and mental component summary scales, referred to as PCS-12 and MCS-12 were evaluated against published normative values and a 15% improvement in these scores was used as an assessment of success. In calculating the true value of a treatment, the scores from the SF-12v2 were converted into a utility index (SF-6D), which considered not only how many years a medical intervention could have added to a patient's life, but also the quality of that life. Use of the SF-6D did not expand the questions administered to the patients. The scale ranged from 0-100% with 100% being the best quality of life.
    Time Frame time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months

    Outcome Measure Data

    Analysis Population Description
    The number analyzed in Mental Health and Physical Health rows for 6 Months and 12 Months differ due to the inability for a participant to complete the required forms for those two intervals.
    Arm/Group Title Discharge Post-Operative 3 Months 6 Months 12 Months 24 Months
    Arm/Group Description Change in Health-Related Quality of Life From Baseline Change in Health-Related Quality of Life From Baseline Change in Health-Related Quality of Life From Baseline Change in Health-Related Quality of Life From Baseline Change in Health-Related Quality of Life From Baseline Change in Health-Related Quality of Life From Baseline
    Measure Participants 91 117 106 104 92 56
    Mental Health
    0.01
    (10)
    4.0
    (12.4)
    4.8
    (11.6)
    7.6
    (12.7)
    7.6
    (10.7)
    7.1
    (11.9)
    Physical Health
    0.6
    (6.8)
    4.6
    (9.3)
    8.2
    (9.2)
    9.7
    (11.5)
    12.9
    (9)
    11.5
    (10.1)
    6. Secondary Outcome
    Title Radiographic Assessments
    Description Quantitative and qualitative radiographic assessment of the pre and post-operative AP, and Lateral, Flexion/Extension images were performed. Radiographic and qualitative assessments performed include: Device Condition: looks at both the cage inside the vertebrae and the hardware outside the vertebrae. It looks at whether or not the device is intact or not (subsidence or migration) Fusion/Non-fusion: whether bone has grown within the space between the spinal vertebrae. If fusion occurs, it results in Bony Bridging
    Time Frame 12 mo to 24 mo

    Outcome Measure Data

    Analysis Population Description
    The numbers are different from the overall number analyzed due to the different number of people who participated in each visit's radiographic analysis
    Arm/Group Title Level 1 Superior Inferior
    Arm/Group Description One vertebrae level analyzed Analysis of the upper level of a two-level vertebrae Analysis of the lower level of a two-level vertebrae
    Measure Participants 95 23 23
    Absent
    2
    1.6%
    3
    NaN
    3
    NaN
    Partial Consolidation
    10
    8%
    2
    NaN
    2
    NaN
    Bridging / Fusion
    33
    26.4%
    11
    NaN
    11
    NaN
    Intact
    0
    0%
    0
    NaN
    0
    NaN
    Loosening
    0
    0%
    0
    NaN
    0
    NaN
    Fracture
    0
    0%
    0
    NaN
    0
    NaN
    Not Applicable
    0
    0%
    0
    NaN
    0
    NaN
    Unable to Assess
    15
    12%
    2
    NaN
    2
    NaN
    Subsidence
    0
    0%
    0
    NaN
    0
    NaN
    Migration
    0
    0%
    0
    NaN
    0
    NaN
    Subsidence & Migration
    0
    0%
    0
    NaN
    0
    NaN
    Other
    0
    0%
    0
    NaN
    0
    NaN
    Absent
    0
    0%
    1
    NaN
    1
    NaN
    Partial Consolidation
    0
    0%
    0
    NaN
    0
    NaN
    Bridging / Fusion
    29
    23.2%
    12
    NaN
    12
    NaN
    Intact
    0
    0%
    0
    NaN
    0
    NaN
    Loosening
    0
    0%
    0
    NaN
    0
    NaN
    Fracture
    0
    0%
    0
    NaN
    0
    NaN
    Not Applicable
    0
    0%
    0
    NaN
    0
    NaN
    Unable to Assess
    0
    0%
    0
    NaN
    0
    NaN
    Subsidence
    2
    1.6%
    0
    NaN
    0
    NaN
    Migration
    0
    0%
    0
    NaN
    0
    NaN
    Subsidence & Migration
    0
    0%
    0
    NaN
    0
    NaN
    Other
    0
    0%
    0
    NaN
    0
    NaN
    Absent
    0
    0%
    0
    NaN
    0
    NaN
    Partial Consolidation
    0
    0%
    0
    NaN
    0
    NaN
    Bridging / Fusion
    0
    0%
    0
    NaN
    0
    NaN
    Intact
    48
    38.4%
    17
    NaN
    17
    NaN
    Loosening
    0
    0%
    1
    NaN
    1
    NaN
    Fracture
    0
    0%
    0
    NaN
    0
    NaN
    Not Applicable
    11
    8.8%
    0
    NaN
    0
    NaN
    Unable to Assess
    1
    0.8%
    0
    NaN
    0
    NaN
    Subsidence
    0
    0%
    0
    NaN
    0
    NaN
    Migration
    0
    0%
    0
    NaN
    0
    NaN
    Subsidence & Migration
    0
    0%
    0
    NaN
    0
    NaN
    Other
    0
    0%
    0
    NaN
    0
    NaN
    Absent
    0
    0%
    0
    NaN
    0
    NaN
    Partial Consolidation
    0
    0%
    0
    NaN
    0
    NaN
    Bridging / Fusion
    0
    0%
    0
    NaN
    0
    NaN
    Intact
    28
    22.4%
    12
    NaN
    12
    NaN
    Loosening
    0
    0%
    1
    NaN
    1
    NaN
    Fracture
    0
    0%
    0
    NaN
    0
    NaN
    Not Applicable
    3
    2.4%
    0
    NaN
    0
    NaN
    Unable to Assess
    0
    0%
    0
    NaN
    0
    NaN
    Subsidence
    0
    0%
    0
    NaN
    0
    NaN
    Migration
    0
    0%
    0
    NaN
    0
    NaN
    Subsidence & Migration
    0
    0%
    0
    NaN
    0
    NaN
    Other
    0
    0%
    0
    NaN
    0
    NaN
    Absent
    0
    0%
    0
    NaN
    0
    NaN
    Partial Consolidation
    0
    0%
    0
    NaN
    0
    NaN
    Bridging / Fusion
    0
    0%
    0
    NaN
    0
    NaN
    Intact
    58
    46.4%
    16
    NaN
    15
    NaN
    Loosening
    0
    0%
    0
    NaN
    0
    NaN
    Fracture
    0
    0%
    0
    NaN
    0
    NaN
    Not Applicable
    0
    0%
    0
    NaN
    0
    NaN
    Unable to Assess
    0
    0%
    0
    NaN
    0
    NaN
    Subsidence
    2
    1.6%
    1
    NaN
    1
    NaN
    Migration
    0
    0%
    0
    NaN
    1
    NaN
    Subsidence & Migration
    0
    0%
    1
    NaN
    0
    NaN
    Other
    0
    0%
    0
    NaN
    1
    NaN
    Absent
    0
    0%
    0
    NaN
    0
    NaN
    Partial Consolidation
    0
    0%
    0
    NaN
    0
    NaN
    Bridging / Fusion
    0
    0%
    0
    NaN
    0
    NaN
    Intact
    31
    24.8%
    13
    NaN
    11
    NaN
    Loosening
    0
    0%
    0
    NaN
    0
    NaN
    Fracture
    0
    0%
    0
    NaN
    0
    NaN
    Not Applicable
    0
    0%
    0
    NaN
    0
    NaN
    Unable to Assess
    0
    0%
    0
    NaN
    0
    NaN
    Subsidence
    0
    0%
    0
    NaN
    1
    NaN
    Migration
    0
    0%
    0
    NaN
    0
    NaN
    Subsidence & Migration
    0
    0%
    0
    NaN
    0
    NaN
    Other
    0
    0%
    0
    NaN
    1
    NaN
    7. Secondary Outcome
    Title Patient Satisfaction
    Description At the 12 month and 24 month follow-up visits, subjects were asked whether they were satisfied with the outcome of their surgery (Yes/No) and whether they would repeat the operation (Yes/No).
    Time Frame 12 month and 24 month

    Outcome Measure Data

    Analysis Population Description
    Patient self-assessment of the procedure at 12M and 24M
    Arm/Group Title 12 Month Repeat Procedure
    Arm/Group Description Patient satisfaction at 12 Month Patient satisfaction at 24 Month
    Measure Participants 97 56
    Yes
    80
    64%
    51
    NaN
    No
    11
    8.8%
    5
    NaN
    Not Reported
    6
    4.8%
    0
    NaN
    Yes
    80
    64%
    51
    NaN
    No
    11
    8.8%
    5
    NaN
    Not Reported
    6
    4.8%
    0
    NaN
    8. Secondary Outcome
    Title Odom's Criteria
    Description At the 24 month follow-up visit, the Investigator rated the clinical disposition of each study subject according to Odom's Criteria as follows: Excellent: all pre-operative symptoms relieved, able to carry out daily occupations without impairment. Good: minimum persistence of pre-operative symptoms, able to carry out daily occupations without significant interference. Fair/Satisfactory: relief of some pre-operative symptoms but physical activity is significantly limited. Poor: symptoms or signs unchanged or worse.
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title 24 Month
    Arm/Group Description Odom's criteria
    Measure Participants 56
    Excellent
    33
    26.4%
    Good
    17
    13.6%
    Fair/Satisfactory
    5
    4%
    Not Reported
    1
    0.8%
    9. Secondary Outcome
    Title Surgery Time
    Description The length of the surgical procedure from the initial incision to final closure were captured from the Anesthesia Record.
    Time Frame During operation.

    Outcome Measure Data

    Analysis Population Description
    3 of 125 subjects did not have surgery time included. There were 12 staged procedures increasing the overall number of procedures to 134
    Arm/Group Title Surgery Time
    Arm/Group Description The length of the surgical procedure
    Measure Participants 122
    Measure surgeries 134
    Mean (Standard Deviation) [Minutes]
    142
    (62.7)
    10. Secondary Outcome
    Title Anesthesia Time
    Description The length of time the patient is under anesthesia were captured from the Anesthesia Record.
    Time Frame During operation.

    Outcome Measure Data

    Analysis Population Description
    3 of 125 subjects did not have surgery time included. There were 12 staged procedures increasing the overall number of procedures to 134
    Arm/Group Title Anesthesia Time
    Arm/Group Description The length of time the patient is under anesthesia
    Measure Participants 122
    Measure surgeries 134
    Mean (Standard Deviation) [Minutes]
    219.8
    (84.9)
    11. Secondary Outcome
    Title Estimated Blood Loss
    Description The amount of blood loss over the entire length of the surgery, documented on the Anesthesia Record, was captured.
    Time Frame During Operation

    Outcome Measure Data

    Analysis Population Description
    11 of 125 subjects did not have blood loss included. There were 12 staged procedures increasing the overall number of procedures to 126.
    Arm/Group Title Estimated Blood Loss
    Arm/Group Description The amount of blood loss over the entire length of the surgery
    Measure Participants 114
    Measure surgeries 126
    Mean (Standard Deviation) [Cubic Centimeters]
    76.5
    (78.9)
    12. Secondary Outcome
    Title Number of Participants With Abnormal Neuromonitoring System Results
    Description Abnormal result(s) of neuromonitoring systems (Train of Four, Electromyography (EMG), Triggered EMG, Somato Sensory Evoked Potential (SSEP) and Motor Evoked Potential (MEP)) utilized during the surgery were captured.
    Time Frame During operation

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Train of Four Electromyography (EMG) Triggered EMG Somato Sensory Evoked Potential (SSEP) Motor Evoked Potential (MEP)
    Arm/Group Description Abnormal result(s) of neuromonitoring systems utilized during the surgery Abnormal result(s) of neuromonitoring systems utilized during the surgery Abnormal result(s) of neuromonitoring systems utilized during the surgery Abnormal result(s) of neuromonitoring systems utilized during the surgery Abnormal result(s) of neuromonitoring systems utilized during the surgery
    Measure Participants 85 121 119 75 30
    Count of Participants [Participants]
    1
    0.8%
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    13. Secondary Outcome
    Title Length of Hospital Stay
    Description The length of hospital stay from the date of hospital admission to the date of discharge was calculated.
    Time Frame From admission to discharge

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Length of Hospital Stay
    Arm/Group Description The length of hospital stay from the date of hospital admission to the date of discharge
    Measure Participants 125
    Mean (Standard Deviation) [Days]
    4.5
    (3.3)
    14. Secondary Outcome
    Title Change in Work/School Status Compared to Baseline
    Description The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented.
    Time Frame Pre-operative to 24 months

    Outcome Measure Data

    Analysis Population Description
    All patients who participated in each interval were accounted for including the missing category
    Arm/Group Title Pre-Op Initial Post-Operative 3 Months 6 Months 12 Months 24 Months
    Arm/Group Description The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery
    Measure Participants 125 122 111 104 97 56
    Unemployed, unrelated to back/leg conditions
    16
    12.8%
    25
    NaN
    22
    NaN
    22
    NaN
    16
    NaN
    8
    NaN
    Not attending work/school by choice
    42
    33.6%
    35
    NaN
    36
    NaN
    31
    NaN
    35
    NaN
    21
    NaN
    Unable to go due to back/leg pain/conditions
    30
    24%
    41
    NaN
    24
    NaN
    18
    NaN
    16
    NaN
    10
    NaN
    Attending work/school with some restrictions
    25
    20%
    15
    NaN
    14
    NaN
    15
    NaN
    8
    NaN
    5
    NaN
    Attending work/school with no restrictions
    12
    9.6%
    5
    NaN
    14
    NaN
    17
    NaN
    20
    NaN
    12
    NaN
    Missing
    0
    0%
    1
    NaN
    1
    NaN
    1
    NaN
    2
    NaN
    0
    NaN
    15. Secondary Outcome
    Title Change in Use of Narcotics Post-Surgery Compared to Baseline
    Description The types and dosages of any narcotics taken by the patient post-surgery were documented.
    Time Frame Pre-operative to 24 months

    Outcome Measure Data

    Analysis Population Description
    All patients who participated in each interval were accounted for including the missing category
    Arm/Group Title Pre-Op Initial Post-Operative 3 Months 6 Months 12 Months 24 Months
    Arm/Group Description The types and dosages of any narcotics taken by the patient post-surgery The types and dosages of any narcotics taken by the patient post-surgery The types and dosages of any narcotics taken by the patient post-surgery The types and dosages of any narcotics taken by the patient post-surgery The types and dosages of any narcotics taken by the patient post-surgery The types and dosages of any narcotics taken by the patient post-surgery
    Measure Participants 125 122 111 104 97 56
    None
    15
    12%
    15
    NaN
    23
    NaN
    26
    NaN
    30
    NaN
    24
    NaN
    Non-narcotics or NSAIDs
    42
    33.6%
    20
    NaN
    25
    NaN
    28
    NaN
    29
    NaN
    14
    NaN
    Intermittent short-acting narcotics
    21
    16.8%
    38
    NaN
    34
    NaN
    27
    NaN
    16
    NaN
    7
    NaN
    Chronic daily short-acting narcotics
    30
    24%
    24
    NaN
    20
    NaN
    17
    NaN
    15
    NaN
    9
    NaN
    Chronic daily long-acting narcotics
    16
    12.8%
    19
    NaN
    7
    NaN
    6
    NaN
    3
    NaN
    1
    NaN
    IV or injected narcotics
    1
    0.8%
    6
    NaN
    1
    NaN
    0
    NaN
    1
    NaN
    1
    NaN
    Missing
    0
    0%
    0
    NaN
    1
    NaN
    0
    NaN
    3
    NaN
    0
    NaN
    None
    103
    82.4%
    97
    NaN
    90
    NaN
    79
    NaN
    64
    NaN
    41
    NaN
    Non-narcotics or NSAIDs
    14
    11.2%
    14
    NaN
    11
    NaN
    17
    NaN
    22
    NaN
    12
    NaN
    Intermittent short-acting narcotics
    2
    1.6%
    4
    NaN
    6
    NaN
    5
    NaN
    7
    NaN
    1
    NaN
    Chronic daily short-acting narcotics
    5
    4%
    5
    NaN
    2
    NaN
    2
    NaN
    1
    NaN
    2
    NaN
    Chronic daily long-acting narcotics
    1
    0.8%
    2
    NaN
    0
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    IV or injected narcotics
    0
    0%
    0
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    Missing
    0
    0%
    0
    NaN
    1
    NaN
    0
    NaN
    3
    NaN
    0
    NaN

    Adverse Events

    Time Frame Operative to 24+ Months
    Adverse Event Reporting Description Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
    Arm/Group Title Participants With Adverse Events
    Arm/Group Description Participants were evaluated for all adverse events including device related, procedure related, and additional serious adverse events. 9 of the 30 SAE participants did not experience a non-SAE events. The other 21 participants had events in both categories. The study did not establish a frequency threshold, therefore, all AEs are listed.
    All Cause Mortality
    Participants With Adverse Events
    Affected / at Risk (%) # Events
    Total 0/125 (0%)
    Serious Adverse Events
    Participants With Adverse Events
    Affected / at Risk (%) # Events
    Total 30/125 (24%)
    Cardiac disorders
    Cardiac failure 1/125 (0.8%) 1
    Gastrointestinal disorders
    Abdominal pain 1/125 (0.8%) 1
    Abdominal pain lower 1/125 (0.8%) 1
    Functional gastrointestinal disorder 1/125 (0.8%) 1
    Intestinal pseudo-obstruction 1/125 (0.8%) 1
    Small intestinal obstruction 1/125 (0.8%) 1
    Infections and infestations
    Appendicitis 1/125 (0.8%) 1
    Postoperative wound infection 1/125 (0.8%) 1
    Injury, poisoning and procedural complications
    Adjacent segment degeneration 1/125 (0.8%) 1
    Cerebrospinal fluid leakage 1/125 (0.8%) 1
    Fall 1/125 (0.8%) 1
    Metabolism and nutrition disorders
    Fluid overload 1/125 (0.8%) 1
    Hyponatraemia 1/125 (0.8%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 2/125 (1.6%) 2
    Arthritis 1/125 (0.8%) 2
    Back pain 1/125 (0.8%) 2
    Groin pain 1/125 (0.8%) 1
    Intervertebral disc protrusion 1/125 (0.8%) 1
    Intervertebral disc space narrowing 1/125 (0.8%) 2
    Muscular weakness 1/125 (0.8%) 2
    Neck pain 2/125 (1.6%) 2
    Osteoarthritis 1/125 (0.8%) 1
    Pain in extremity 3/125 (2.4%) 6
    Nervous system disorders
    Cerebrovascular accident 1/125 (0.8%) 1
    Cervical cord compression 1/125 (0.8%) 1
    Cervical radiculopathy 1/125 (0.8%) 1
    Dural tear 2/125 (1.6%) 2
    Headache 1/125 (0.8%) 1
    Lethargy 1/125 (0.8%) 1
    Lumbar radiculopathy 1/125 (0.8%) 1
    Lumbar spinal stenosis 2/125 (1.6%) 2
    Metabolic encephalopathy 1/125 (0.8%) 2
    Syncope 1/125 (0.8%) 1
    Product Issues
    Device dislocation 2/125 (1.6%) 3
    Psychiatric disorders
    Confusional state 1/125 (0.8%) 1
    Renal and urinary disorders
    Bladder dysfunction 1/125 (0.8%) 1
    Urinary retention 2/125 (1.6%) 2
    Surgical and medical procedures
    Wound drainage 2/125 (1.6%) 2
    Carpal tunnel decompression 1/125 (0.8%) 2
    Cholecystectomy 1/125 (0.8%) 1
    Inguinal hernia repair 1/125 (0.8%) 1
    Medical device removal 2/125 (1.6%) 2
    Pituitary tumour removal 1/125 (0.8%) 1
    Spinal decompression 1/125 (0.8%) 1
    Spinal fusion surgery 2/125 (1.6%) 2
    Spinal laminectomy 1/125 (0.8%) 1
    Other (Not Including Serious) Adverse Events
    Participants With Adverse Events
    Affected / at Risk (%) # Events
    Total 73/125 (58.4%)
    Blood and lymphatic system disorders
    Anaemia postoperative 1/125 (0.8%) 1
    Cardiac disorders
    Bradycardia 1/125 (0.8%) 1
    Ear and labyrinth disorders
    Ear pain 1/125 (0.8%) 1
    Eye disorders
    Eyelid ptosis 1/125 (0.8%) 1
    Vision blurred 1/125 (0.8%) 1
    Gastrointestinal disorders
    Abdominal discomfort 1/125 (0.8%) 1
    Abdominal hernia 1/125 (0.8%) 1
    Abdominal pain 1/125 (0.8%) 1
    Anorectal disorder 1/125 (0.8%) 1
    Constipation 1/125 (0.8%) 1
    Functional gastrointestinal disorder 1/125 (0.8%) 1
    Nausea 1/125 (0.8%) 1
    General disorders
    Asthenia 1/125 (0.8%) 1
    Chest pain 2/125 (1.6%) 2
    Discomfort 1/125 (0.8%) 2
    Dysplasia 1/125 (0.8%) 1
    Fat necrosis 1/125 (0.8%) 1
    Fatigue 1/125 (0.8%) 1
    Nodule 1/125 (0.8%) 1
    Pain 2/125 (1.6%) 2
    Pyrexia 4/125 (3.2%) 4
    Swelling 1/125 (0.8%) 1
    Tissue injury 2/125 (1.6%) 4
    Hepatobiliary disorders
    Hepatic lesion 1/125 (0.8%) 1
    Infections and infestations
    Abscess 1/125 (0.8%) 1
    Appendicitis 1/125 (0.8%) 1
    Bronchitis 1/125 (0.8%) 1
    Upper respiratory tract infection 1/125 (0.8%) 1
    Urinary tract infection 5/125 (4%) 5
    Wound infection 3/125 (2.4%) 3
    Injury, poisoning and procedural complications
    Eye contusion 1/125 (0.8%) 2
    Fall 11/125 (8.8%) 13
    Joint injury 1/125 (0.8%) 1
    Road traffic accidents 1/125 (0.8%) 1
    skin laceration 1/125 (0.8%) 1
    Metabolism and nutrition disorders
    Osteoporosis 1/125 (0.8%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 15/125 (12%) 16
    Arthritis 1/125 (0.8%) 1
    Back pain 19/125 (15.2%) 25
    Bursitis 2/125 (1.6%) 2
    Costochondritis 1/125 (0.8%) 1
    Facet joint syndrome 1/125 (0.8%) 1
    Gout 1/125 (0.8%) 1
    Intervertebral disc degeneration 2/125 (1.6%) 2
    Meniscus injury 1/125 (0.8%) 1
    Muscle injury 2/125 (1.6%) 4
    Muscle spasms 1/125 (0.8%) 1
    Muscle tightness 1/125 (0.8%) 2
    Muscular weakness 1/125 (0.8%) 1
    Musculoskeletal pain 13/125 (10.4%) 16
    Neck pain 8/125 (6.4%) 8
    Pain in extremity 18/125 (14.4%) 24
    Pseuarthrosis 2/125 (1.6%) 2
    Spinal compression fracture 1/125 (0.8%) 1
    Spinal fracture 1/125 (0.8%) 1
    Spinal osteoarthritis 1/125 (0.8%) 1
    Nervous system disorders
    Cervical radiculopathy 1/125 (0.8%) 1
    Dural tear 1/125 (0.8%) 1
    Dysaesthesia 2/125 (1.6%) 2
    Headache 1/125 (0.8%) 1
    Hypoaesthesia 7/125 (5.6%) 8
    Lumbar radiculopathy 1/125 (0.8%) 1
    Lumbar spinal stenosis 1/125 (0.8%) 1
    Neuralgia 1/125 (0.8%) 1
    Neuropathy peripheral 1/125 (0.8%) 2
    Paraesthesia 2/125 (1.6%) 2
    Peroneal nerve palsy 2/125 (1.6%) 3
    Piriformis syndrome 1/125 (0.8%) 1
    Spinal claudication 1/125 (0.8%) 1
    Syncope 1/125 (0.8%) 1
    Vertebral foraminal stenosis 1/125 (0.8%) 1
    Product Issues
    Device failure 1/125 (0.8%) 1
    Psychiatric disorders
    Anxiety 2/125 (1.6%) 2
    Attention deficit / hyperactivity disorder 1/125 (0.8%) 1
    Depression 2/125 (1.6%) 2
    Obsessive-compulsive disorder 1/125 (0.8%) 1
    Renal and urinary disorders
    Bladder dysfunction 1/125 (0.8%) 2
    Urinary retention 4/125 (3.2%) 5
    Reproductive system and breast disorders
    Orchitis 1/125 (0.8%) 1
    Testicular swelling 1/125 (0.8%) 1
    Uterine leiomyoma 1/125 (0.8%) 1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 1/125 (0.8%) 1
    Hypoxia 1/125 (0.8%) 1
    Skin and subcutaneous tissue disorders
    Cellulitis 1/125 (0.8%) 1
    Erythema 1/125 (0.8%) 1
    Surgical and medical procedures
    Blepharoplasty 1/125 (0.8%) 1
    Corneal suture 1/125 (0.8%) 1
    Incisional drainage 1/125 (0.8%) 1
    Spinal fusion 1/125 (0.8%) 1
    Vascular disorders
    Deep vein thrombosis 1/125 (0.8%) 1
    Ecchymosis 1/125 (0.8%) 1
    Haematoma 1/125 (0.8%) 1
    Haemorrhoidal haemorrhage 1/125 (0.8%) 1
    Rectal haemorrhage 1/125 (0.8%) 1
    Uterine haemorrhage 1/125 (0.8%) 1

    Limitations/Caveats

    Early termination leading to small numbers of subjects analyzed.

    More Information

    Certain Agreements

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

    The Institution/PI shall not disclose/use any confidential/proprietary information (CI) disclosed to/developed by the Institution during the study. Institution/PI agree to hold the results of the Study in confidence, and shall not disclose them except with prior written consent of K2M. Institution agrees to submit any Articles to K2M for review prior to publication and agrees to edit out any confidential information identified by K2M.

    Results Point of Contact

    Name/Title Marissa Conrad, Senior Director of Clinical and Medical Affairs
    Organization Stryker Spine
    Phone 201-749-8162
    Email marissa.conrad@stryker.com
    Responsible Party:
    K2M, Inc.
    ClinicalTrials.gov Identifier:
    NCT02068729
    Other Study ID Numbers:
    • CA-002
    First Posted:
    Feb 21, 2014
    Last Update Posted:
    Apr 5, 2021
    Last Verified:
    Apr 1, 2021