Spondylolisthesis Clinical Trial
Official title:
Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis - CLEOS Study
Study to evaluate the superiority of the osteosynthesis associated with a decompressive surgery in comparison with a simple decompressive surgery in the treatment of lumbar degenerative stenosis with spondylolisthesis
Randomized, comparative study on 152 patients with degenerative spondylolisthesis L4-L5
confirmed by radiography with radicular pain for whom the antalgic and anti-inflammatory
treatment are not efficient for at least 3 months.
Patients randomized in 2 parallel groups (each group with 76 patients)
- one group with decompressive surgery + osteosynthesis
- one group with decompressive surgery Study duration : 18 months, including a selection
visit, an inclusion with the surgical intervention, 3, 12, 18 months' follow up visits
and a follow up call at 6 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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