Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT00401518
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT00401518
Study Brief:
Protocol Section:
NCT00401518