This is a prospective, multicentric, comparative, randomised-controlled study to evaluate the safety and efficacy of the Facet Fixation implant.
The main objective is to evaluate the effectiveness of spinal decompression associated with FFX® implants compared to spinal decompression alone in treating lumbar spinal stenosis after 2 years of treatment.
Age ≥ 50 years.
Radiographic confirmation of clinical symptoms of at least moderate degenerative spinal stenosis, of 1 to 3 adjacent segments in the L1-S1 region with the need for surgical decompression.
Radiographic confirmation of no translational instability in main segment as well as in adjacent segments (dynamic translational instability ≤3 mm);
Visual analogue scale (VAS) back pain score ≥ 50 mm (on a 100-mm scale).
Prior lumbar spine surgery.
Radiographically confirmed damage of a vertebral body (e.g., osteoporotic compression fracture or because of tumours), at any lumbar level.
Isthmic or degenerative spondylolisthesis (anterolisthesis; retrolisthesis ≥ grade II) or spondylolysis (pars fracture).
Degenerative lumbar scoliosis (Cobb angle > 25°).