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

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 - Purpan - Neurosurgery department
Toulouse, 31, France, 31059
Toulouse University Hospital - Rangueil- Neuro surgery 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:

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 (Phila Pa 1976). 1994 Jun 1;19(11):1201-6.

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.

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.

Fritzell P, Hägg 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.

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.


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 Bone Diseases Musculoskeletal Diseases	Spinal Diseases Spondylolysis Spondylosis

ClinicalTrials.gov processed this record on February 27, 2015

Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis (CLEOS)