Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis
NCT ID: NCT00252551
Last Updated: 2015-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
11 participants
INTERVENTIONAL
2005-03-31
2007-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
osteosynthesis
Osteosynthesis
2
Simple surgery
Simple surgery
Surgery without device
Interventions
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Osteosynthesis
Simple surgery
Surgery without device
Eligibility Criteria
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Inclusion Criteria
* Patients who agree to take part in the study and to sign an Informed Consent Form
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Jacques Lagarrigue
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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University Hospital of Besançon - Neurosurgey department
Besançon, , France
University Hospital of Caen - Neurosurgery department
Caen, , France
University Hospital of Clermont Ferrand
Clermont-Ferrand, , France
Clinique Rech - Neurosurgery centre
Montpellier, , France
University Hospital of Nice - Neurosurgery department
Nice, , France
University Hospital of Saint-Etienne - Neurosurgery department
Saint-Etienne, , France
University Hospital of Strasbourg
Strasbourg, , France
Toulouse University Hospital - Purpan - Neurosurgery department
Toulouse, , France
Toulouse University Hospital - Rangueil- Neuro surgery department
Toulouse, , France
Countries
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References
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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.
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.
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.
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, 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.
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.
Other Identifiers
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PHRC0300201
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
0300201
Identifier Type: -
Identifier Source: org_study_id
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