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

Completed · Not applicable

Conditions studied: Lumbar Spinal Stenosis

In brief

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.

Key facts

Study ID

NCT00401518

Run by

Globus Medical Inc

People needed

390

Starts

2006-10-01

Expected to finish

2017-10-01

Last updated by the study team

2020-09-10

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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