NCT00252551

Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis

Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis - CLEOS Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spondylolisthesis

Interventions

Type	Name	Description
PROCEDURE	Osteosynthesis
PROCEDURE	Simple surgery	Surgery without device

Timeline

• Start date: 2005-03-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2005-11-11
• Last updated: 2015-03-17

Locations

9 sites across 1 country: France