TerminatedNot Applicable

Evaluation of the Prosthetic Disc Replacement

Stopped: Insuffisent recruitment

France301 participantsStarted 2008-02

Plain-language 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.

Who can participate

Age range20 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * cervical disc: * 20 to 55 years old; * symptomatic disc disease between C3-C7 defined as: * Cervical or brachial(radicular) pain and/or functional/neurologic deficit with at least one of the following conditions confirmed by imaging : * Hernia of the gelatinous core; * Spondylosis (osteophytes); loss of height of the disc; * Not reacting to the no-invasive treatment or progressive symptoms or compressions ; * NDI \>= 15/50; * Ready to respect the instructions; * More than one vertebral level requiring a treatment; * At a vertebral block close to the level to be treated; * Associated to a fusion at the adjacent level or another level; * Written assent; * Patient who can receive one or other treatment; * lumbar disc: * 25 to 65 years; * Symptomatology of prevalent lumbago with or without radiculalgia and failure of the medical treatments; * Idiopathic discopathies or after cure of disc herniations (except prior infections); * Repetition of disc herniation (except excluded hernia); * Discopathies with median posterior disc herniation with limited development and loss of discal height; * 1 or 2 contiguous stages or not among L3L4, L4L5, L5S1; * Written assent; * Patient who can receive one or other treatment; Exclusion Criteria: * cervical disc: * Cervical instability: in flexion/extension Translation \> 3 mm and /or \>11 degrees of rotary difference with one or the other adjacent level; * Serious problem o…

What they're measuring

Patient satisfaction at one year. Oswestry questionnaire (lumbar pathology) or NDI questionnaire (cervical pathology), SF36 score and Visual Analog Scale (Pain

Timeframe: 1 year

Trial details

NCT IDNCT00640029

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-02