Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis

Spondylolisthesis Clinical Trial

— CLEOS  

Official title:

Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis - CLEOS Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00252551
• Other study ID #: 0300201
• Secondary ID: PHRC0300201
• Status: Terminated
• Phase: N/A
• First received: November 10, 2005
• Last updated: March 15, 2015
• Start date: March 2005
• Est. completion date: December 2007

Study information

• Verified date: March 2015
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spondylolisthesis

Intervention

Procedure:
• Osteosynthesis

• Simple surgery
Surgery without device

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (6)

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

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	improvement of patients' Quality of Life (SF36)		M18	No
Secondary	radiologic stability of spondylolisthesis		M18	Yes
Secondary	safety of the used surgical procedures		M3, M12, M18	Yes