Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis (CLEOS)

This study has been terminated.
(Insufficient recruitment)
Sponsor:
Information provided by:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00252551
First received: November 10, 2005
Last updated: June 23, 2008
Last verified: June 2008
  Purpose

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


Condition Intervention
Spondylolisthesis
Procedure: Osteosynthesis
Procedure: Simple surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis - CLEOS Study

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improvement of patients' Quality of Life (SF36) [ Time Frame: M18 ] [ Designated as safety issue: No ]
  • radiologic stability of spondylolisthesis [ Time Frame: M18 ] [ Designated as safety issue: Yes ]
  • safety of the used surgical procedures [ Time Frame: M3, M12, M18 ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: March 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
osteosynthesis
Procedure: Osteosynthesis
Active Comparator: 2
Simple surgery
Procedure: Simple surgery
Surgery without device

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252551

Locations
France
University Hospital of Nice - Neurosurgery department
Nice, 06, France, 06002
University Hospital of Caen - Neurosurgery department
Caen, 14, France, 14033
University Hospital of Besançon - Neurosurgey department
Besançon, 25, France, 25030
Toulouse University Hospital - Rangueil- Neuro surgery department
Toulouse, 31, France, 31059
Toulouse University Hospital - Purpan - Neurosurgery department
Toulouse, 31, France, 31059
Clinique Rech - Neurosurgery centre
Montpellier, 34, France, 34094
University Hospital of Saint-Etienne - Neurosurgery department
Saint-Etienne, 42, France, 42055
University Hospital of Clermont Ferrand
Clermont Ferrand, 63, France, 63003
University Hospital of Starsbourg
Strasbourg, 67, France, 67098
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Jacques Lagarrigue Toulouse University Hospital
  More Information

Publications:
Responsible Party: LLAU Marie-Elise, University Hospital Toulouse
ClinicalTrials.gov Identifier: NCT00252551     History of Changes
Other Study ID Numbers: 0300201, PHRC0300201, CLEOS study
Study First Received: November 10, 2005
Last Updated: June 23, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
spondylolisthesis, decompressive surgery, osteosynthesis

Additional relevant MeSH terms:
Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 22, 2014