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Evaluation of the Prosthetic Disc Replacement

NCT00640029 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2015-03-10

No results posted yet for this study

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.

Conditions

  • Lumbar Degenerative Disc Disease
  • Cervical Degenerative Disc Disease
  • Kyphosis

Interventions

PROCEDURE

Arthrodesis

* posterior, * anterior, * circumference approach

DEVICE

Arthroplasty (PRODISC-C® , PRODISC-L®, Mobi-C®, Mobidisc®, PrestigeLP®, A-Mav®, O-Mav®, DISCOCERV®)

* SYNTHES : PRODISC-C® , PRODISC-L® * LDR : Mobi-C®, Mobidisc® * MEDTRONIC : PrestigeLP®, A-Mav®, O-Mav® * SCIENT'X : DISCOCERV®

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Philippe Cottin, MD · Assistance Publique - Hôpitaux de Paris

  • Jacques BRUNON, MD, PhD · Saint-Etienne's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00640029 on ClinicalTrials.gov