Clinical Trial Comparing Decompression With and Without Coflex™ Interlaminar Technology Treating … (NCT01316211) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial Comparing Decompression With and Without Coflexâ„¢ Interlaminar Technology Treating Lumbar Spinal Stenosis
Germany246 participantsStarted 2008-01
Plain-language summary
A 2 year comparative evaluation of clinical outcome in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with and without additional stabilization using the coflex® Interlaminar Technology
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
✓. Radiographic confirmation of clinical symptoms of at least moderate degenerative spinal stenosis, with constriction of the central spinal canal of one or two adjacent segments in the region L3 to L5 with the need for decompression.
✓. Radiographic confirmation of no translatory instability in the main segment as well as in adjacent segments (dynamic translatory instability ≤ 3 mm).
✓. VAS back pain score of at least 50 mm on a 100 mm scale (for acute back pain or a period of at least 3 month of back pain before the onset of leg pain).
✓. Minimum of 3 months conservative therapy without improvement of symptoms.
✓. Age \>40 years.
✓. Oswestry Low Back Pain Disability Questionnaire score of at least 18/45 (40%) for German sites or 20/50 (40%) for the US sites (The question about sexual life will be excluded).
✓. Suitability of the patient for a posterior surgery procedure.
✓. Mental and physical ability of patient to follow the protocol according to compliance to time schedule, treatment plan, fill in of CRF pages and further study procedures.
Exclusion criteria
✕. Preceding fusion or decompression surgery of the lumbar spine or preceding nucleotomy of the segments of concern (also if nucleotomy becomes necessary during surgery).
✕. Radiographically confirmed damage of the vertebral body in the segment of concern in the lumbar spine (e.g. osteoporotic compression fracture or because of tumors)