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Clinical Trial Title
A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis
Status Recruiting
Sponsors
Facet Solutions, Inc.
Purpose
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.
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Genders Eligible for Study: Both
Ages eligible for study: 21 Years to 85 Years
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 retrolithesis;
- Spondylolisthesis at levels other than at the operative level;
- Scoliosis of the lumbar spine (defined as more than 11 deg sagittal deformity);
- 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 or receiving Workers Compensation related to back pain or injury;
- Is a prisoner.
More Information
Study ID numbers:
1020-9052
ClinicalTrials Identifier - NCT00401518
For additional information, visit ClinicalTrials.gov.
Information obtained from ClinicalTrials.gov on 11/23/2009
This directory includes clinical trials that involve researchers at UCSD Medical
Center. The information was obtained from ClinicalTrials.gov, a database of the
U.S. National Institutes of Health.
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