A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis

• Sponsor: Globus Medical Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00401518
• Collaborator: (none)
• Enrollment: 390
• Locations: 29
• Arms: 2
• Duration (Months): 132
• Patients Per Site: 13.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if the ACADIA® Facet Replacement System is effective in the treatment of spinal stenosis. The primary objective of the study is to evaluate the overall success rate of the Anatomic Facet Replacement System in patients with spinal stenosis when compared to a posterior spinal fusion control.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Spinal Stenosis	Device: Non-randomized ACADIA® Facet Replacement System; Device: Randomized ACADIA® Facet Replacement System; Device: Randomized Instrumented posterolateral fusion (PLF)	N/A

Detailed Description

Spinal Stenosis continues to be a major cause of back and leg pain. The condition is attributed to narrowing of the space around the nerves in the lumbar spine. This is often caused by the degenerative process in the spine and the facet joints. The current treatment calls for removal of bone around the affected nerve including the facet joints and fusing the posterior of the spine to ensure the segments remain stable.

The ACADIA® Facet Replacement System (AFRS) allows for an anatomic reconstruction of the facet joint after decompression and removal of the degenerated facet. Like the original facet joint, the replacement implant is designed to reproduce facet motion while restoring normal stability and motion.

The ACADIA® Facet Replacement System (AFRS) has been designed on the principals that have allowed other total joint replacement procedures to provide significant patient benefits.

These guiding principals include:

• Anatomically based implant design

• Reproducible surgical technique

• Elimination of pain

The ACADIA® Facet Replacement System allows the surgeon to remove the offending bone while preserving the motion of the facet joint.

This study will evaluate the outcomes of patients using the AFRS™ investigation compared to those receiving instrumented posterior fusion procedure. Patients will be required to complete study visits before the procedure and at 6 weeks, 3, 6, 12, 24 months post procedure and annually thereafter as required by FDA. Follow up visits consist of administration of questionnaires, radiographs and neurological assessment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 390 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Investigational Plan for the Evaluation of the ACADIA® Facet Replacement System
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Aug 1, 2017
• Actual Study Completion Date: Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ACADIA® Investigational surgical treatment using the ACADIA Facet Replacement system	Device: Non-randomized ACADIA® Facet Replacement System; Non-randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis; Device: Randomized ACADIA® Facet Replacement System; Randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis
Active Comparator: Control Instrumented PLF Control surgical treatment using an instrumented posterolateral fusion	Device: Randomized Instrumented posterolateral fusion (PLF); Randomized control treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis

Outcome Measures

Primary Outcome Measures

1. Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Physical Function Score [24 months]

   Physical Function is measured on a scale of 1-4 points (lower values are considered a better outcome)

2. Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score [24 months]

   Symptom Severity is measured on a scale of 1-5 points (lower values are considered a better outcome)

3. Number of Participants Who Maintained or Improved in Neurological Status. [24 months]

   Neurological status is based on four types of measurement parameters: muscle strength, straight leg raise, sensory function, and reflexes. Each of the four parameters will be coded as Stable or Improved OR Deteriorated. Neurological assessment scores must be stable or improved compared with the preoperative baseline to be considered "Stable or Improved" neurological status. If these scores have deteriorated as compared to the preoperative baseline, then the neurological status is considered "Deteriorated".

Secondary Outcome Measures

1. Mean Visual Analog Scale (VAS) Right Leg Pain [24 months]

   The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "as severe as it could be" on the right border. The subject is instructed to make a mark along the line to represent the intensity of right leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.

2. Mean Visual Analog Scale (VAS) Left Leg Pain [24 months]

   The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "as severe as it could be" on the right border. The subject is instructed to make a mark along the line to represent the intensity of left leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.

3. Mean Visual Analog Scale (VAS) Back Pain [24 months]

   The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "as severe as it could be" on the right border. The subject is instructed to make a mark along the line to represent the intensity of back pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.

4. Number of Participants With a Change of at Least 15 Points in Pain/Disability Using the Oswestry Disability Index (ODI) Score at 24 Months Compared With the Score at Baseline [24 months]

   The Oswestry Disability Index (ODI) is a commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 21-85 years of age and skeletally mature;

• Have undergone 6 months of non-operative treatment prior to surgery;

• Lateral, lateral recess and/or central canal stenosis;

• Disc height measuring ≥ 4 mm at the operative level;

• Persistent leg, thigh and/or buttock symptoms,including pain,numbness, burning or tingling with a minimum leg pain score of 40mm as measured with the Visual Analogue Scale (VAS) Index;

• A score greater than 2 on a scale of 1-5 on the Zurich Claudication Questionnaire (ZCQ) Symptom Severity (SS) Score-Candidate;

• A score greater than or equal to 2 on a scale of 1-4 on the ZCQ Physical Function (PF) Score;

• A candidate for a decompression with full facetectomy at the operative level

• Candidate for a posterior lumbar fusion;

• Physically and mentally willing and able to comply evaluations;

• Lives in the immediate area and has no plans to relocate;

Exclusion Criteria:

• Previous surgical procedure at the operative or adjacent level except for one of the following: Micro-discectomy, laminectomy, lamino/foraminotomy, rhizotomy, IDET, and/or interspinous spacer;

• Previous lumbar fusion or disc replacement procedure;

• Osteoporosis;

• greater than Grade I spondylolisthesis or retrolisthesis;

• Spondylolisthesis at levels other than at the operative level;

• Scoliosis of the lumbar spine (defined as more than 11 deg Cobb angle) as indicated by plain X-ray films;

• Primary diagnosis of discogenic back pain due to torn, herniated, inflamed or irritated disc or other pathology where the patient exhibits axial back pain from degenerative disc disease;

• Acute traumatic pars fracture at the operative/adjacent level vertebral body;

• Spinal stenosis at more than three lumbar segments;

• Acute trauma to the lumbar spine within the last 24 months;

• Active infection at the operative level, or a systemic infection;

• Physically / mentally compromised;

• Systemic disease that would affect the patient's welfare or the research study.

• Immunologically suppressed or immunocompromised;

• Insulin-Dependent Diabetes Mellitus (Type I Diabetes);

• Currently undergoing long-term steroid therapy;

• Metabolic bone disease;

• Active malignancy: (except non-melanoma skin cancer), unless treated with no clinical signs or symptoms of the malignancy for at least 5 years;

• Known allergy to cobalt chromium or titanium;

• Used any investigational drug or device within the past 30 days;

• Pending litigation related to back pain or injury;

• Is a prisoner.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Spine Group Beverly Hills	Beverly Hills	California	United States	90211
2	Cedars-Sinai Spine Center	Los Angeles	California	United States	90048
3	Desert Orthopaedic Center	Rancho Mirage	California	United States	92270
4	Boulder Neurosurgical & Spine Associates	Boulder	Colorado	United States	80303
5	Spine Colorado	Durango	Colorado	United States	81301
6	Rocky Mountain Associates (RMA) in Orthopedic Medicine	Loveland	Colorado	United States	80538
7	Florida Spine Institute	Clearwater	Florida	United States	33765
8	Foundation for Orthopaedic Research and Education	Tampa	Florida	United States	33637
9	Neurological Institute of Savannah and Center for Spine	Savannah	Georgia	United States	31405
10	Indiana Spine Group	Carmel	Indiana	United States	46032
11	Fort Wayne Orthopaedics	Fort Wayne	Indiana	United States	46804
12	Spine Institute of Louisiana	Shreveport	Louisiana	United States	71101
13	Rubin Institute for Advanced Orthopaedics	Owings Mills	Maryland	United States	21117
14	UMASS Memorial Medical Center	Worcester	Massachusetts	United States	01605
15	Spine Midwest, Inc.	Jefferson City	Missouri	United States	65101
16	Springfield Neurological & Spine Institute	Springfield	Missouri	United States	65804
17	Albany Medical Center	Albany	New York	United States	12208
18	Carolina Neurosurgery and Spine Associates, P.C.	Charlotte	North Carolina	United States	28204
19	OrthoCarolina Spine Center	Charlotte	North Carolina	United States	28207
20	Riverhills Healthcare	Cincinnati	Ohio	United States	45242
21	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
22	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
23	Charleston Brain & Spine	Charleston	South Carolina	United States	29406
24	Medical University of South Carolina	Charleston	South Carolina	United States	29425
25	Neuro-Spine Solutions	Bristol	Tennessee	United States	37620
26	The Center for Sports Medicine & Orthopedics	Chattanooga	Tennessee	United States	37404
27	Central Texas Spine Institute	Austin	Texas	United States	78731
28	University of Utah	Salt Lake City	Utah	United States	84108
29	University of Puerto Rico	San Juan		Puerto Rico	00921

Sponsors and Collaborators

• Globus Medical Inc

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 14, 2013

More Information

Publications

None provided.

• Responsible Party: Globus Medical Inc
• ClinicalTrials.gov Identifier: NCT00401518
• Other Study ID Numbers: 1020-9052
• First Posted: Nov 20, 2006
• Last Update Posted: Sep 10, 2020
• Last Verified: Aug 1, 2020

• Keywords provided by Globus Medical Inc: Spinal Stenosis; Lumbar Spinal Stenosis; Facet Arthroplasty; Posterior Fusion; Facet Arthritis
• Additional relevant MeSH terms: Spinal Stenosis; Constriction, Pathologic

Study Results

Participant Flow

Arm/Group Title	Non-randomized ACADIA®	Randomized ACADIA®	Randomized Instrumented PLF
Arm/Group Description	Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Period Title: Overall Study
STARTED	46	227	117
COMPLETED	40	190	94
NOT COMPLETED	6	37	23

Baseline Characteristics

Arm/Group Title	Non-randomized ACADIA®	Randomized ACADIA®	Randomized Instrumented PLF	Total
Arm/Group Description	Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis	Total of all reporting groups
Overall Participants	46	227	117	390
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.6 (11.46)	61.7 (9.82)	61.4 (10.55)	61.2 (10.27)
Sex: Female, Male (Count of Participants)
Female	22 47.8%	119 52.4%	55 47%	196 50.3%
Male	24 52.2%	108 47.6%	62 53%	194 49.7%
Race/Ethnicity, Customized (Count of Participants)
Asian or Pacific Islander	0 0%	5 2.2%	0 0%	5 1.3%
Black or African American	1 2.2%	2 0.9%	7 6%	10 2.6%
Caucasian	41 89.1%	206 90.7%	103 88%	350 89.7%
Hispanic	3 6.5%	12 5.3%	7 6%	22 5.6%
Other	1 2.2%	2 0.9%	0 0%	3 0.8%
Height (inches) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [inches]	67.3 (3.91)	66.9 (4.41)	67.4 (3.86)	67.1 (4.19)
Weight (pounds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pounds]	190.8 (41.34)	191.3 (39.62)	191.2 (37.38)	191.2 (39.07)

Outcome Measures

1. Primary Outcome

Title	Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Physical Function Score
Description	Physical Function is measured on a scale of 1-4 points (lower values are considered a better outcome)
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Non-randomized ACADIA®	Randomized ACADIA®	Randomized Instrumented PLF
Arm/Group Description	Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Measure Participants	40	190	94
Mean (Standard Deviation) [score on a scale]	1.7 (0.71)	1.6 (0.62)	1.7 (0.73)

2. Primary Outcome

Title	Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score
Description	Symptom Severity is measured on a scale of 1-5 points (lower values are considered a better outcome)
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

One patient from the Randomized ACADIA group did not have ZCQ Symptom Severity data at 24 months

Arm/Group Title	Non-randomized ACADIA®	Randomized ACADIA®	Randomized Instrumented PLF
Arm/Group Description	Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Measure Participants	40	189	94
Mean (Standard Deviation) [score on a scale]	2.1 (0.90)	2.0 (0.80)	2.2 (0.98)

3. Primary Outcome

Title	Number of Participants Who Maintained or Improved in Neurological Status.
Description	Neurological status is based on four types of measurement parameters: muscle strength, straight leg raise, sensory function, and reflexes. Each of the four parameters will be coded as Stable or Improved OR Deteriorated. Neurological assessment scores must be stable or improved compared with the preoperative baseline to be considered "Stable or Improved" neurological status. If these scores have deteriorated as compared to the preoperative baseline, then the neurological status is considered "Deteriorated".
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Only patients with Neurological data at 24 months and treated with ACADIA or the control treatment were analyzed

Arm/Group Title	Non-randomized ACADIA®	Randomized ACADIA®	Randomized Instrumented PLF
Arm/Group Description	Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Measure Participants	43	204	99
Count of Participants [Participants]	30 65.2%	155 68.3%	75 64.1%

4. Secondary Outcome

Title	Mean Visual Analog Scale (VAS) Right Leg Pain
Description	The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "as severe as it could be" on the right border. The subject is instructed to make a mark along the line to represent the intensity of right leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Non-randomized ACADIA®	Randomized ACADIA®	Randomized Instrumented PLF
Arm/Group Description	Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Measure Participants	40	190	94
Mean (Standard Deviation) [score on a scale]	19.4 (28.11)	13.2 (24.97)	22.5 (30.80)

5. Secondary Outcome

Title	Mean Visual Analog Scale (VAS) Left Leg Pain
Description	The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "as severe as it could be" on the right border. The subject is instructed to make a mark along the line to represent the intensity of left leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Non-randomized ACADIA®	Randomized ACADIA®	Randomized Instrumented PLF
Arm/Group Description	Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Measure Participants	40	190	94
Mean (Standard Deviation) [score on a scale]	17.5 (29.72)	12.2 (24.25)	16.9 (26.68)

6. Secondary Outcome

Title	Mean Visual Analog Scale (VAS) Back Pain
Description	The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "as severe as it could be" on the right border. The subject is instructed to make a mark along the line to represent the intensity of back pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Non-randomized ACADIA®	Randomized ACADIA®	Randomized Instrumented PLF
Arm/Group Description	Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Measure Participants	40	190	94
Mean (Standard Deviation) [score on a scale]	24.7 (30.23)	18.8 (25.24)	23.9 (26.86)

7. Secondary Outcome

Title	Number of Participants With a Change of at Least 15 Points in Pain/Disability Using the Oswestry Disability Index (ODI) Score at 24 Months Compared With the Score at Baseline
Description	The Oswestry Disability Index (ODI) is a commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Six Non-randomized ACADIA®, 37 Randomized ACADIA® and 23 Randomized instrumented PLF did not complete the 24 month visit and thus were not analyzed.

Arm/Group Title	Non-randomized ACADIA®	Randomized ACADIA®	Randomized Instrumented PLF
Arm/Group Description	Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis	Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Measure Participants	40	190	94
Count of Participants [Participants]	33 71.7%	151 66.5%	62 53%

Adverse Events

Time Frame	24 months
Adverse Event Reporting Description	The Total Number of Participants at Risk for the "Randomized ACADIA" Arm/Group is not consistent with numbers provided in the Participant Flow module. The discrepancy is due to one patient being randomized to ACADIA but not receiving the ACADIA treatment. This patient is included in the intent-to-treat population for efficacy analyses. It is not possible to make any changes to data including Adverse Event Terms as the study is closed and all analysis is complete.
Arm/Group Title	Non-randomized ACADIA®		Randomized ACADIA®		Randomized Instrumented PLF
Arm/Group Description	Non-randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis		Randomized investigational surgical treatment using the ACADIA Facet Replacement system for the treatment of lumbar spinal stenosis		Randomized control surgical treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
All Cause Mortality
	Non-randomized ACADIA®		Randomized ACADIA®		Randomized Instrumented PLF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/46 (4.3%)		4/226 (1.8%)		3/117 (2.6%)
Serious Adverse Events
	Non-randomized ACADIA®		Randomized ACADIA®		Randomized Instrumented PLF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/46 (43.5%)		111/226 (49.1%)		40/117 (34.2%)
Cardiac disorders
Cardiovascular	3/46 (6.5%)		15/226 (6.6%)		7/117 (6%)
Gastrointestinal disorders
Gastrointestinal	3/46 (6.5%)		12/226 (5.3%)		6/117 (5.1%)
General disorders
Death	0/46 (0%)		4/226 (1.8%)		0/117 (0%)
Other	0/46 (0%)		5/226 (2.2%)		2/117 (1.7%)
Trauma	2/46 (4.3%)		1/226 (0.4%)		3/117 (2.6%)
Vertebral Fracture	0/46 (0%)		1/226 (0.4%)		0/117 (0%)
Radiographic	0/46 (0%)		1/226 (0.4%)		0/117 (0%)
Immune system disorders
Metal Allergy	0/46 (0%)		1/226 (0.4%)		0/117 (0%)
Infections and infestations
Infection - Deep Wound	0/46 (0%)		3/226 (1.3%)		0/117 (0%)
Infection - Other	2/46 (4.3%)		8/226 (3.5%)		5/117 (4.3%)
Infection - Superficial Wound	0/46 (0%)		1/226 (0.4%)		0/117 (0%)
Musculoskeletal and connective tissue disorders
Pain-Neck and/or Upper Extremity	1/46 (2.2%)		4/226 (1.8%)		3/117 (2.6%)
Pain - Back	0/46 (0%)		3/226 (1.3%)		1/117 (0.9%)
Pain-Back and Lower Extremities	0/46 (0%)		2/226 (0.9%)		0/117 (0%)
Pain Lower Extremities	2/46 (4.3%)		13/226 (5.8%)		8/117 (6.8%)
Pain - Hip	1/46 (2.2%)		11/226 (4.9%)		2/117 (1.7%)
Musculoskeletal	0/46 (0%)		2/226 (0.9%)		0/117 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	0/46 (0%)		5/226 (2.2%)		0/117 (0%)
Nervous system disorders
Dural Tear	0/46 (0%)		2/226 (0.9%)		1/117 (0.9%)
Neurological Focal Lumbar	0/46 (0%)		1/226 (0.4%)		0/117 (0%)
Psychiatric disorders
Psychological	0/46 (0%)		1/226 (0.4%)		0/117 (0%)
Renal and urinary disorders
Urogenital	4/46 (8.7%)		5/226 (2.2%)		2/117 (1.7%)
Respiratory, thoracic and mediastinal disorders
Respiratory	0/46 (0%)		4/226 (1.8%)		5/117 (4.3%)
Skin and subcutaneous tissue disorders
Wound Issue	0/46 (0%)		1/226 (0.4%)		0/117 (0%)
Surgical and medical procedures
Surgery - Adjacent Level	1/46 (2.2%)		10/226 (4.4%)		0/117 (0%)
Surgery - Index Level	7/46 (15.2%)		35/226 (15.5%)		13/117 (11.1%)
Surgery - Other (Non-Lumbar)	1/46 (2.2%)		1/226 (0.4%)		0/117 (0%)
Surgery - Other Lumbar	1/46 (2.2%)		0/226 (0%)		1/117 (0.9%)
Vascular disorders
Cerebrovascular	0/46 (0%)		5/226 (2.2%)		1/117 (0.9%)
Other (Not Including Serious) Adverse Events
	Non-randomized ACADIA®		Randomized ACADIA®		Randomized Instrumented PLF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	46/46 (100%)		213/226 (94.2%)		108/117 (92.3%)
Cardiac disorders
Cardiovascular	10/46 (21.7%)		21/226 (9.3%)		13/117 (11.1%)
Gastrointestinal disorders
Gastrointestinal	9/46 (19.6%)		32/226 (14.2%)		9/117 (7.7%)
General disorders
Headache	1/46 (2.2%)		3/226 (1.3%)		0/117 (0%)
Other	20/46 (43.5%)		42/226 (18.6%)		24/117 (20.5%)
Pain - Other	0/46 (0%)		5/226 (2.2%)		2/117 (1.7%)
Trauma	11/46 (23.9%)		42/226 (18.6%)		26/117 (22.2%)
Spinous Process Fracture	0/46 (0%)		1/226 (0.4%)		0/117 (0%)
Vertebral Fracture	0/46 (0%)		2/226 (0.9%)		1/117 (0.9%)
Weakness	0/46 (0%)		2/226 (0.9%)		4/117 (3.4%)
Dural Tear	2/46 (4.3%)		22/226 (9.7%)		12/117 (10.3%)
Radiographic	1/46 (2.2%)		5/226 (2.2%)		0/117 (0%)
Hepatobiliary disorders
Pseudoarthrosis	0/46 (0%)		0/226 (0%)		2/117 (1.7%)
Immune system disorders
Metal Allergy	0/46 (0%)		1/226 (0.4%)		0/117 (0%)
Infections and infestations
Infection - Superficial Wound	1/46 (2.2%)		4/226 (1.8%)		2/117 (1.7%)
Infection - Other	9/46 (19.6%)		23/226 (10.2%)		17/117 (14.5%)
Musculoskeletal and connective tissue disorders
Muscle Spasms	0/46 (0%)		4/226 (1.8%)		1/117 (0.9%)
Pain-Neck and/or Upper Extremity	9/46 (19.6%)		30/226 (13.3%)		22/117 (18.8%)
Pain - Back	19/46 (41.3%)		72/226 (31.9%)		27/117 (23.1%)
Pain-Back and Lower Extremities	6/46 (13%)		34/226 (15%)		17/117 (14.5%)
Pain - Back and Hip	0/46 (0%)		3/226 (1.3%)		1/117 (0.9%)
Pain Lower Extremities	18/46 (39.1%)		68/226 (30.1%)		38/117 (32.5%)
Pain - Hip	12/46 (26.1%)		28/226 (12.4%)		14/117 (12%)
Musculoskeletal	5/46 (10.9%)		18/226 (8%)		13/117 (11.1%)
Pain-Back and Lower Extremities with Dysesthesia	2/46 (4.3%)		10/226 (4.4%)		2/117 (1.7%)
Pain-Back with Dysesthesia	0/46 (0%)		2/226 (0.9%)		1/117 (0.9%)
Pain Lower Extremities with Dysesthesia	3/46 (6.5%)		8/226 (3.5%)		5/117 (4.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	2/46 (4.3%)		2/226 (0.9%)		4/117 (3.4%)
Nervous system disorders
Dysesthesia - Upper Extremities	1/46 (2.2%)		0/226 (0%)		1/117 (0.9%)
Dysesthesia - Lower Extremities	2/46 (4.3%)		2/226 (0.9%)		2/117 (1.7%)
Neurological Systemic	1/46 (2.2%)		4/226 (1.8%)		1/117 (0.9%)
Dysesthesia - Other	0/46 (0%)		3/226 (1.3%)		1/117 (0.9%)
Paresthesia - Upper Extremities	4/46 (8.7%)		7/226 (3.1%)		4/117 (3.4%)
Paresthesia - Lower Extremities	4/46 (8.7%)		22/226 (9.7%)		10/117 (8.5%)
Paresthesia - Other	1/46 (2.2%)		0/226 (0%)		0/117 (0%)
Neurological Focal Lumbar	21/46 (45.7%)		104/226 (46%)		50/117 (42.7%)
Neurolgical Focal Other	3/46 (6.5%)		10/226 (4.4%)		3/117 (2.6%)
Peripheral Neuropathy	1/46 (2.2%)		5/226 (2.2%)		1/117 (0.9%)
Psychiatric disorders
Psychological	0/46 (0%)		8/226 (3.5%)		1/117 (0.9%)
Renal and urinary disorders
Urogenital	2/46 (4.3%)		21/226 (9.3%)		5/117 (4.3%)
Respiratory, thoracic and mediastinal disorders
Respiratory	2/46 (4.3%)		16/226 (7.1%)		7/117 (6%)
Skin and subcutaneous tissue disorders
Wound Issue	1/46 (2.2%)		5/226 (2.2%)		4/117 (3.4%)
Surgical and medical procedures
Surgery - Adjacent Level	0/46 (0%)		3/226 (1.3%)		2/117 (1.7%)
Surgery-Index Level	2/46 (4.3%)		6/226 (2.7%)		1/117 (0.9%)
Surgery - Other (Non-Lumbar)	1/46 (2.2%)		2/226 (0.9%)		0/117 (0%)
Surgery - Other Lumbar	0/46 (0%)		1/226 (0.4%)		0/117 (0%)
Vascular disorders
Cerebrovascular	1/46 (2.2%)		3/226 (1.3%)		0/117 (0%)

Limitations/Caveats

[Not Specified]

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

To prevent premature disclosure of trade secrets or other confidential information, Investigator agrees not to present, publish, or disclose study results or information about the investigational device without the express written consent of the sponsor.