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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00401518
Other study ID # 1020-9052
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2006
Est. completion date October 2017

Study information

Verified date August 2020
Source Globus Medical Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 390
Est. completion date October 2017
Est. primary completion date August 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 85 Years
Eligibility 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.

Study Design


Intervention

Device:
Non-randomized ACADIA® Facet Replacement System
Non-randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis
Randomized ACADIA® Facet Replacement System
Randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis
Randomized Instrumented posterolateral fusion (PLF)
Randomized control treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis

Locations

Country Name City State
Puerto Rico University of Puerto Rico San Juan
United States Abington Memorial Hospital Abington Pennsylvania
United States Albany Medical Center Albany New York
United States Central Texas Spine Institute Austin Texas
United States Spine Group Beverly Hills Beverly Hills California
United States Boulder Neurosurgical & Spine Associates Boulder Colorado
United States Neuro-Spine Solutions Bristol Tennessee
United States Indiana Spine Group Carmel Indiana
United States Charleston Brain & Spine Charleston South Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Carolina Neurosurgery and Spine Associates, P.C. Charlotte North Carolina
United States OrthoCarolina Spine Center Charlotte North Carolina
United States The Center for Sports Medicine & Orthopedics Chattanooga Tennessee
United States Riverhills Healthcare Cincinnati Ohio
United States Florida Spine Institute Clearwater Florida
United States Spine Colorado Durango Colorado
United States Fort Wayne Orthopaedics Fort Wayne Indiana
United States Spine Midwest, Inc. Jefferson City Missouri
United States Cedars-Sinai Spine Center Los Angeles California
United States Rocky Mountain Associates (RMA) in Orthopedic Medicine Loveland Colorado
United States Rubin Institute for Advanced Orthopaedics Owings Mills Maryland
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States Desert Orthopaedic Center Rancho Mirage California
United States University of Utah Salt Lake City Utah
United States Neurological Institute of Savannah and Center for Spine Savannah Georgia
United States Spine Institute of Louisiana Shreveport Louisiana
United States Springfield Neurological & Spine Institute Springfield Missouri
United States Foundation for Orthopaedic Research and Education Tampa Florida
United States UMASS Memorial Medical Center Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Globus Medical Inc

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 24 months
Primary 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) 24 months
Primary 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". 24 months
Secondary 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. 24 months
Secondary 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. 24 months
Secondary 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. 24 months
Secondary 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. 24 months
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