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Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis (CLEOS)

This study has been terminated.
(Insufficient recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00252551
First Posted: November 11, 2005
Last Update Posted: March 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Toulouse
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • improvement of patients' Quality of Life (SF36) [ Time Frame: M18 ]
  • radiologic stability of spondylolisthesis [ Time Frame: M18 ]
  • safety of the used surgical procedures [ Time Frame: M3, M12, M18 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00252551


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

Publications:
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00252551     History of Changes
Other Study ID Numbers: 0300201
PHRC0300201 ( Other Grant/Funding Number: French Ministry of Health )
First Submitted: November 10, 2005
First Posted: November 11, 2005
Last Update Posted: March 17, 2015
Last Verified: March 2015

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

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