Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis - Full Text View

Sponsored by:	University Hospital, Toulouse
Information provided by:	University Hospital, Toulouse
ClinicalTrials.gov Identifier:	NCT00252551

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

MedlinePlus related topics: Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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
1: Experimental osteosynthesis	Procedure: Osteosynthesis
2: Active Comparator 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, 06
University Hospital of Nice - Neurosurgery department
Nice, 06, France, 06002
France, 14
University Hospital of Caen - Neurosurgery department
Caen, 14, France, 14033
France, 25
University Hospital of Besançon - Neurosurgey department
Besançon, 25, France, 25030
France, 31
Toulouse University Hospital - Rangueil- Neuro surgery department
Toulouse, 31, France, 31059
Toulouse University Hospital - Purpan - Neurosurgery department
Toulouse, 31, France, 31059
France, 34
Clinique Rech - Neurosurgery centre
Montpellier, 34, France, 34094
France, 42
University Hospital of Saint-Etienne - Neurosurgery department
Saint-Etienne, 42, France, 42055
France, 63
University Hospital of Clermont Ferrand
Clermont Ferrand, 63, France, 63003
France, 67
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:

Caputy AJ, Luessenhop AJ. Long-term evaluation of decompressive surgery for degenerative lumbar stenosis. J Neurosurg. 1992 Nov;77(5):669-76. Review.

Cherkin DC, Deyo RA, Loeser JD, Bush T, Waddell G. An international comparison of back surgery rates. Spine. 1994 Jun 1;19(11):1201-6.

Davis H. Increasing rates of cervical and lumbar spine surgery in the United States, 1979-1990. Spine. 1994 May 15;19(10):1117-23; discussion 1123-4.

Feffer HL, Wiesel SW, Cuckler JM, Rothman RH. Degenerative spondylolisthesis. To fuse or not to fuse. Spine. 1985 Apr;10(3):287-9.

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. 2001 Dec 1;26(23):2521-32; discussion 2532-4.

Gibson JN, Grant IC, Waddell G. The Cochrane review of surgery for lumbar disc prolapse and degenerative lumbar spondylosis. Spine. 1999 Sep 1;24(17):1820-32.

Responsible Party:	University Hospital Toulouse ( LLAU Marie-Elise )
Study ID Numbers:	0300201, PHRC0300201, CLEOS study
Study First Received:	November 10, 2005
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00252551
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Toulouse:

spondylolisthesis, decompressive surgery, osteosynthesis

Study placed in the following topic categories:

Spinal Diseases
Musculoskeletal Diseases
Constriction, Pathologic
Spondylolisthesis
Bone Diseases

ClinicalTrials.gov processed this record on February 12, 2009