Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis (CLEOS)
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ClinicalTrials.gov Identifier: NCT00252551 |
Recruitment Status
:
Terminated
(Insufficient recruitment)
First Posted
: November 11, 2005
Last Update Posted
: March 17, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spondylolisthesis | Procedure: Osteosynthesis Procedure: Simple surgery | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
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 |
Study Start Date : | March 2005 |
Actual Primary Completion Date : | December 2007 |
Actual Study Completion Date : | December 2007 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
osteosynthesis
|
Procedure: Osteosynthesis |
Active Comparator: 2
Simple surgery
|
Procedure: Simple surgery
Surgery without device
|
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Principal Investigator: | Jacques Lagarrigue | Toulouse University Hospital |
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 Posted: | November 11, 2005 Key Record Dates |
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 |