Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis

Not Applicable

Terminated

• Conditions: Spondylolisthesis
• Interventions: Procedure: Osteosynthesis; Procedure: Simple surgery

• Registration Number: NCT00252551
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-11-10
• Study First Submitted QC: 2005-11-10
• Study First Posted: 2005-11-11
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-15
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Osteosynthesis	osteosynthesis
2	Simple surgery	Simple surgery

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
radiologic stability of spondylolisthesis	M18
safety of the used surgical procedures	M3, M12, M18
improvement of patients' Quality of Life (SF36)	M18

Trial Locations

Locations (9)

University Hospital of Besançon - Neurosurgey department; 🇫🇷 Besançon, France

University Hospital of Caen - Neurosurgery department; 🇫🇷 Caen, France

University Hospital of Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

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