Evaluation of the Prosthetic Disc Replacement (NCT00640029) | Clinical Trial Compass
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 range
20 Years – 65 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient satisfaction at one year. Oswestry questionnaire (lumbar pathology) or NDI questionnaire (cervical pathology), SF36 score and Visual Analog Scale (Pain