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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014