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Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis (CLEOS)

Primary Purpose

Spondylolisthesis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Osteosynthesis
Simple surgery
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondylolisthesis focused on measuring spondylolisthesis, decompressive surgery, osteosynthesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Besançon - Neurosurgey department
  • University Hospital of Caen - Neurosurgery department
  • University Hospital of Clermont Ferrand
  • Clinique Rech - Neurosurgery centre
  • University Hospital of Nice - Neurosurgery department
  • University Hospital of Saint-Etienne - Neurosurgery department
  • University Hospital of Strasbourg
  • Toulouse University Hospital - Purpan - Neurosurgery department
  • Toulouse University Hospital - Rangueil- Neuro surgery department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

osteosynthesis

Simple surgery

Outcomes

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

Secondary Outcome Measures

improvement of patients' Quality of Life (SF36)
radiologic stability of spondylolisthesis
safety of the used surgical procedures

Full Information

First Posted
November 10, 2005
Last Updated
March 15, 2015
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT00252551
Brief Title
Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis
Acronym
CLEOS
Official Title
Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis - CLEOS Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment
Study Start Date
March 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylolisthesis
Keywords
spondylolisthesis, decompressive surgery, osteosynthesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
osteosynthesis
Arm Title
2
Arm Type
Active Comparator
Arm Description
Simple surgery
Intervention Type
Procedure
Intervention Name(s)
Osteosynthesis
Intervention Type
Procedure
Intervention Name(s)
Simple surgery
Intervention Description
Surgery without device
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
improvement of patients' Quality of Life (SF36)
Time Frame
M18
Title
radiologic stability of spondylolisthesis
Time Frame
M18
Title
safety of the used surgical procedures
Time Frame
M3, M12, M18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Lagarrigue
Organizational Affiliation
Toulouse University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Besançon - Neurosurgey department
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
University Hospital of Caen - Neurosurgery department
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
University Hospital of Clermont Ferrand
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Clinique Rech - Neurosurgery centre
City
Montpellier
ZIP/Postal Code
34094
Country
France
Facility Name
University Hospital of Nice - Neurosurgery department
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
University Hospital of Saint-Etienne - Neurosurgery department
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
University Hospital of Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Toulouse University Hospital - Purpan - Neurosurgery department
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Toulouse University Hospital - Rangueil- Neuro surgery department
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
1403105
Citation
Caputy AJ, Luessenhop AJ. Long-term evaluation of decompressive surgery for degenerative lumbar stenosis. J Neurosurg. 1992 Nov;77(5):669-76. doi: 10.3171/jns.1992.77.5.0669.
Results Reference
background
PubMed Identifier
8073310
Citation
Cherkin DC, Deyo RA, Loeser JD, Bush T, Waddell G. An international comparison of back surgery rates. Spine (Phila Pa 1976). 1994 Jun 1;19(11):1201-6. doi: 10.1097/00007632-199405310-00001.
Results Reference
background
PubMed Identifier
8059266
Citation
Davis H. Increasing rates of cervical and lumbar spine surgery in the United States, 1979-1990. Spine (Phila Pa 1976). 1994 May 15;19(10):1117-23; discussion 1123-4. doi: 10.1097/00007632-199405001-00003.
Results Reference
background
PubMed Identifier
3992350
Citation
Feffer HL, Wiesel SW, Cuckler JM, Rothman RH. Degenerative spondylolisthesis. To fuse or not to fuse. Spine (Phila Pa 1976). 1985 Apr;10(3):287-9.
Results Reference
background
PubMed Identifier
11725230
Citation
Fritzell P, Hagg O, Wessberg P, Nordwall A; Swedish Lumbar Spine Study Group. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2521-32; discussion 2532-4. doi: 10.1097/00007632-200112010-00002.
Results Reference
background
PubMed Identifier
10488513
Citation
Gibson JN, Grant IC, Waddell G. The Cochrane review of surgery for lumbar disc prolapse and degenerative lumbar spondylosis. Spine (Phila Pa 1976). 1999 Sep 1;24(17):1820-32. doi: 10.1097/00007632-199909010-00012.
Results Reference
background

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Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis

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