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°).
Parallel
Decompression + FFX®
DeviceSurgical treatment of degenerative lumbar spinal stenosis by spinal decompression associated with the use of FFX® implant
Decompression alone
Procedure/SurgerySurgical treatment of degenerative lumbar spinal stenosis by spinal decompression alone
Proportion of subjects with composite clinical success (CCS)
The CCS will be considered as met if ALL of the following criteria are satisfied for a subject: * Back pain score (VAS) decrease by more than 20 mm (on 100-mm scale) * No secondary surgical intervention at the index level (excluding wound problems) * No non-surgical lumbar treatment of interest at any lumbar level
This trial is not recruiting at the moment. You can still explore other options:
