Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis (CLEOS)

Toulouse University Hospital

Status: Terminated

Conditions: Spondylolisthesis

Treatments: Procedure: Osteosynthesis; Procedure: Simple surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00252551

0300201

PHRC0300201 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

1

Experimental group

Description:

osteosynthesis

Treatment:

Procedure: Osteosynthesis

2

Active Comparator group

Description:

Simple surgery

Treatment:

Procedure: Simple surgery