Clinical trial NCT00252551: Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis
Official title: Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis - CLEOS Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spondylolisthesis
Keywords: spondylolisthesis, decompressive surgery, osteosynthesis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2005-11-11
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: M3, M12, M18
Secondary outcomes:
measure: improvement of patients' Quality of Life (SF36)
timeFrame: M18
measure: radiologic stability of spondylolisthesis
timeFrame: M18
measure: safety of the used surgical procedures
timeFrame: M3, M12, M18
Other outcomes:
Locations:
city: Besançon
country: France
facility: University Hospital of Besançon - Neurosurgey department
city: Caen
country: France
facility: University Hospital of Caen - Neurosurgery department
city: Clermont Ferrand
country: France
facility: University Hospital of Clermont Ferrand
city: Montpellier
country: France
facility: Clinique Rech - Neurosurgery centre
city: Nice
country: France
facility: University Hospital of Nice - Neurosurgery department
city: Saint-Etienne
country: France
facility: University Hospital of Saint-Etienne - Neurosurgery department
city: Strasbourg
country: France
facility: University Hospital of Strasbourg
city: Toulouse
country: France
facility: Toulouse University Hospital - Purpan - Neurosurgery department
city: Toulouse
country: France
facility: Toulouse University Hospital - Rangueil- Neuro surgery department
Study officials:
affiliation: University Hospital, Toulouse
name: Jacques Lagarrigue
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.