Back to resultsA Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis
Primary Purpose
Lumbar Spinal Stenosis
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Non-randomized ACADIA® Facet Replacement System
Randomized ACADIA® Facet Replacement System
Randomized Instrumented posterolateral fusion (PLF)
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring Spinal Stenosis, Lumbar Spinal Stenosis, Facet Arthroplasty, Posterior Fusion, Facet Arthritis
Eligibility Criteria
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.
Sites / Locations
- Spine Group Beverly Hills
- Cedars-Sinai Spine Center
- Desert Orthopaedic Center
- Boulder Neurosurgical & Spine Associates
- Spine Colorado
- Rocky Mountain Associates (RMA) in Orthopedic Medicine
- Florida Spine Institute
- Foundation for Orthopaedic Research and Education
- Neurological Institute of Savannah and Center for Spine
- Indiana Spine Group
- Fort Wayne Orthopaedics
- Spine Institute of Louisiana
- Rubin Institute for Advanced Orthopaedics
- UMASS Memorial Medical Center
- Spine Midwest, Inc.
- Springfield Neurological & Spine Institute
- Albany Medical Center
- Carolina Neurosurgery and Spine Associates, P.C.
- OrthoCarolina Spine Center
- Riverhills Healthcare
- Abington Memorial Hospital
- Allegheny General Hospital
- Charleston Brain & Spine
- Medical University of South Carolina
- Neuro-Spine Solutions
- The Center for Sports Medicine & Orthopedics
- Central Texas Spine Institute
- University of Utah
- University of Puerto Rico
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ACADIA®
Control Instrumented PLF
Arm Description
Investigational surgical treatment using the ACADIA Facet Replacement system
Control surgical treatment using an instrumented posterolateral fusion
Outcomes
Primary Outcome Measures
Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Physical Function Score
Physical Function is measured on a scale of 1-4 points (lower values are considered a better outcome)
Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score
Symptom Severity is measured on a scale of 1-5 points (lower values are considered a better outcome)
Number of Participants Who Maintained or Improved in Neurological Status.
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
Mean Visual Analog Scale (VAS) Right Leg Pain
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.
Mean Visual Analog Scale (VAS) Left Leg Pain
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.
Mean Visual Analog Scale (VAS) Back Pain
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00401518
Brief Title
A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis
Official Title
The Investigational Plan for the Evaluation of the ACADIA® Facet Replacement System
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Globus Medical Inc
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis
Keywords
Spinal Stenosis, Lumbar Spinal Stenosis, Facet Arthroplasty, Posterior Fusion, Facet Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
390 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACADIA®
Arm Type
Experimental
Arm Description
Investigational surgical treatment using the ACADIA Facet Replacement system
Arm Title
Control Instrumented PLF
Arm Type
Active Comparator
Arm Description
Control surgical treatment using an instrumented posterolateral fusion
Intervention Type
Device
Intervention Name(s)
Non-randomized ACADIA® Facet Replacement System
Intervention Description
Non-randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis
Intervention Type
Device
Intervention Name(s)
Randomized ACADIA® Facet Replacement System
Intervention Description
Randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis
Intervention Type
Device
Intervention Name(s)
Randomized Instrumented posterolateral fusion (PLF)
Intervention Description
Randomized control treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Primary Outcome Measure Information:
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
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
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
Secondary Outcome Measure Information:
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
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Spine Group Beverly Hills
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Cedars-Sinai Spine Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Desert Orthopaedic Center
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Boulder Neurosurgical & Spine Associates
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
Spine Colorado
City
Durango
State/Province
Colorado
ZIP/Postal Code
81301
Country
United States
Facility Name
Rocky Mountain Associates (RMA) in Orthopedic Medicine
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Florida Spine Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Foundation for Orthopaedic Research and Education
City
Tampa
State/Province
Florida
ZIP/Postal Code
33637
Country
United States
Facility Name
Neurological Institute of Savannah and Center for Spine
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Indiana Spine Group
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Fort Wayne Orthopaedics
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Spine Institute of Louisiana
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Rubin Institute for Advanced Orthopaedics
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
UMASS Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Spine Midwest, Inc.
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65101
Country
United States
Facility Name
Springfield Neurological & Spine Institute
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Carolina Neurosurgery and Spine Associates, P.C.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
OrthoCarolina Spine Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Riverhills Healthcare
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Charleston Brain & Spine
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Neuro-Spine Solutions
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
The Center for Sports Medicine & Orthopedics
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Central Texas Spine Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
University of Puerto Rico
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis
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