Evaluation of the Prosthetic Disc Replacement — EVA  

Kyphosis Clinical Trial

Official title: Medico-economic Evaluation of the Prosthetic Replacement of the Lumbar and Cervical Intervertebral Disc

Status Terminated

Clinical Trial Summary

Until now, arthrodesis (intervertebral fusion) is the formal treatment for the lumbar and cervical degenerative disc disease : arthrodesis has been the standard surgical treatment for the patients when nonsurgical management has failed. However , it has shown out some drawbacks : pseudoarthrosis may appear in the short term, and junctional degeneration in the long term.

The replacement of the intervertebral disc by a prosthesis (arthroplasty) has been since a few years a major alternative therapeutic to the arthrodesis.: it demonstrates great functional results and less post-interventional complications. It is indicated to restore a normal function of the spine (motion is kept)and to avoid deterioration of the adjacent spinal segments over the long time.

In this clinical study, we will distinguish the cervical discal pathology and the lumbar discal pathology.

The purpose of this study is to analyze the results of the arthroplasty in terms of functional effects, quality of life, anatomical results and economical results.

Clinical Trial Description

The purpose of this study is to evaluate the cervical and lumbar intervertebral disc replacement by a prosthesis ( arthroplasty ) in adults suffering from degenerative disc disease.

For the cervical pathology, a comparative randomized multi-site study of the medico-economic evaluation of the prosthesis implementation versus arthrodesis, the standard treatment, will be realised , for patients from 20 to 55 years old, within very rigorous exclusion and inclusion criteria.

For the lumbar pathology, a comparative randomized multi-site study of the medico-economic evaluation of the prosthesis implementation versus arthrodesis, the standard treatment, will be realized , for patients from 50 to 65 years old, within acute exclusion and inclusion criteria.

For patients under 50 years old, randomization is not used as arthroplasty offers very good results. By these young patients, a cohort study will thus be realized.

Patients with degenerative discal disease at one or more levels will be recruited in 17 sites in France :

• 3 sites in ASSITANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

• 14 sites in France outside AP-HP.

The study will have 3 parts :

• Cervical pathology : 500 patients divided on 250 arthroplasties and 250 arthrodeses.

• Lumbar pathology : 525 patients divided according to their age:

• over 50 years old : randomization in 175 lumbar arthroplasties and 175 lumbar arthrodeses.

• until 50 years old : cohort study : 175 lumbar arthroplasties.

This study will last 3 years : a 2 year-period of inclusion , and a post interventional one year-follow-up period for each included patient.

The duration of the participation in the study for each patient is one year.

7 evaluations will be realized for each patient : pre-interventional visit, intervention, post-interventional visit, visit at 45 days, visit at 3 months, visit at 6 months and visit at one year.

Each visit will comprise different exams and observations.

The criterion of principle judgement will be the quality of life measured as follows :

• For the lumbar pathology, the Oswestry Low Back Pain Disability Questionnaire, the SF36 Questionnaire, the Visual Analog Scale (Pain), at each visit.

• For the cervical pathology : the NDI score, the SF36 Questionnaire, the Visual Analog Scale (Pain), at each visit.

The secondary criteria will be medico-economical and clinical too. Arthrodesis and Arthroplasty will be compared in terms of:

• anatomical results of the intervention

• intervention tolerance

• wear (estimated by the discal height)

• costs of the intervention. ;

Study Design

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

Related Conditions & MeSH terms

• Cervical Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Kyphosis
• Lumbar Degenerative Disc Disease

• NCT number: NCT00640029
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Terminated
• Phase: N/A
• Start date: February 2008
• Completion date: February 2011