Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis

Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis - CLEOS Study

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00252551

Acronym

CLEOS

Enrollment

Registered

2005-11-11

Start date

2005-03-31

Completion date

2007-12-31

Last updated

2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondylolisthesis

Keywords

spondylolisthesis, decompressive surgery, osteosynthesis

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.

Interventions

PROCEDUREOsteosynthesis

PROCEDURESimple surgery

Surgery without device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026