Status:
COMPLETED
A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis
Lead Sponsor:
Globus Medical Inc
Conditions:
Lumbar Spinal Stenosis
Eligibility:
All Genders
21-85 years
Phase:
NA
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 succes...
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 degenerativ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00401518
Start Date
October 1 2006
End Date
October 1 2017
Last Update
September 10 2020
Active Locations (29)
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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