Study Stopped
Insufficient recruitment
Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis
CLEOS
2 other identifiers
interventional
11
1 country
9
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2005
Typical duration for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 10, 2005
CompletedFirst Posted
Study publicly available on registry
November 11, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedMarch 17, 2015
March 1, 2015
2.8 years
November 10, 2005
March 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
M3, M12, M18
Secondary Outcomes (3)
improvement of patients' Quality of Life (SF36)
M18
radiologic stability of spondylolisthesis
M18
safety of the used surgical procedures
M3, M12, M18
Study Arms (2)
1
EXPERIMENTALosteosynthesis
2
ACTIVE COMPARATORSimple surgery
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
University Hospital of Besançon - Neurosurgey department
Besançon, 25030, France
University Hospital of Caen - Neurosurgery department
Caen, 14033, France
University Hospital of Clermont Ferrand
Clermont-Ferrand, 63003, France
Clinique Rech - Neurosurgery centre
Montpellier, 34094, France
University Hospital of Nice - Neurosurgery department
Nice, 06002, France
University Hospital of Saint-Etienne - Neurosurgery department
Saint-Etienne, 42055, France
University Hospital of Strasbourg
Strasbourg, 67098, France
Toulouse University Hospital - Purpan - Neurosurgery department
Toulouse, 31059, France
Toulouse University Hospital - Rangueil- Neuro surgery department
Toulouse, 31059, France
Related Publications (6)
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.
PMID: 1403105BACKGROUNDCherkin 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.
PMID: 8073310BACKGROUNDDavis 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.
PMID: 8059266BACKGROUNDFeffer 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.
PMID: 3992350BACKGROUNDFritzell 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.
PMID: 11725230BACKGROUNDGibson 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.
PMID: 10488513BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacques Lagarrigue
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2005
First Posted
November 11, 2005
Study Start
March 1, 2005
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
March 17, 2015
Record last verified: 2015-03