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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Surgery without device
University Hospital of Besançon - Neurosurgey department
Besançon, France
University Hospital of Caen - Neurosurgery department
Caen, France
University Hospital of Clermont Ferrand
Clermont-Ferrand, France
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 spondylisthesis
Time frame: M3, M12, M18
improvement of patients' Quality of Life (SF36)
Time frame: M18
radiologic stability of spondylolisthesis
Time frame: M18
safety of the used surgical procedures
Time frame: M3, M12, M18
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Clinique Rech - Neurosurgery centre
Montpellier, France
University Hospital of Nice - Neurosurgery department
Nice, France
University Hospital of Saint-Etienne - Neurosurgery department
Saint-Etienne, France
University Hospital of Strasbourg
Strasbourg, France
Toulouse University Hospital - Purpan - Neurosurgery department
Toulouse, France
Toulouse University Hospital - Rangueil- Neuro surgery department
Toulouse, France