Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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.

Official Title
-----------------
Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis - CLEOS Study

Conditions
-----------------
Spondylolisthesis

Intervention / Treatment
-----------------
* Procedure: Osteosynthesis
* Procedure: Simple surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 who agree to take part in the study and to sign an Informed Consent Form Exclusion Criteria: Contre-indications to surgery or to vertebral isolated fixation L4-L5 Previous lumbar surgery Work accidents Psychiatric troubles that may interfere with the clinical evaluation Pregnant women or women who could be pregnant during the study Patient under special supervision or trusteeship Refusal to sign the Informed Consent Form No Public Health Insurance cover

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>osteosynthesis | Procedure: Osteosynthesis<br> <br> |
| Active Comparator: 2<br>Simple surgery | Procedure: Simple surgery<br>* Surgery without device<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | M3, M12, M18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of patients' Quality of Life (SF36) |  | M18 | 
| radiologic stability of spondylolisthesis |  | M18 | 
| safety of the used surgical procedures |  | M3, M12, M18 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spondylolisthesis, decompressive surgery, osteosynthesis