Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis (CLEOS)

Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis - CLEOS Study

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

Study Overview

• Status: Terminated
• Conditions: Spondylolisthesis
• Intervention / Treatment: Procedure: Osteosynthesis; Procedure: Simple surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • University Hospital of Besançon - Neurosurgey department
  • Caen, France, 14033
    • University Hospital of Caen - Neurosurgery department
  • Clermont Ferrand, France, 63003
    • University Hospital of Clermont Ferrand
  • Montpellier, France, 34094
    • Clinique Rech - Neurosurgery centre
  • Nice, France, 06002
    • University Hospital of Nice - Neurosurgery department
  • Saint-Etienne, France, 42055
    • University Hospital of Saint-Etienne - Neurosurgery department
  • Strasbourg, France, 67098
    • University Hospital of Strasbourg
  • Toulouse, France, 31059
    • Toulouse University Hospital - Purpan - Neurosurgery department
  • Toulouse, France, 31059
    • Toulouse University Hospital - Rangueil- Neuro surgery department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; osteosynthesis	Procedure: Osteosynthesis
Active Comparator: 2; Simple surgery	Procedure: Simple surgery; Surgery without device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
improvement of patients' Quality of Life (SF36)	M18
radiologic stability of spondylolisthesis	M18
safety of the used surgical procedures	M3, M12, M18

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Jacques Lagarrigue, Toulouse University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: November 10, 2005
• First Submitted That Met QC Criteria: November 10, 2005
• First Posted (Estimate): November 11, 2005

Study Record Updates

• Last Update Posted (Estimate): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 15, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: spondylolisthesis, decompressive surgery, osteosynthesis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: 0300201; PHRC0300201 (Other Grant/Funding Number: French Ministry of Health)