Status:
TERMINATED
Evaluation of the Prosthetic Disc Replacement
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Lumbar Degenerative Disc Disease
Cervical Degenerative Disc Disease
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief 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 whe...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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 of articular facet or degeneration.;
- Known allergy to cobalt, chromium plates, molybdenum, titanium or polyethylene;
- Clinically compromised vertebrae at level (s) touched after a current or passed traumatism;
- Serious spondylosis (MESOCEPHALES osteophytes; loss height of the disc\>70% or Absence of motion(\< 2°));
- Osteoporosis(DEXA);
- Paget, osteomalacia or metabolic osseous disturbs ;
- Serious Willis disease asking an insulin management;
- Pregnancy;
- Active, local or generalized infection;
- Taking treatments or drugs which one knows that they interfere on the management of the bone/ the soft part (e.g. steroids);
- Rheumatoid arthritis or another disease car-immune;
- Systemic disease (AIDS, HIV, hepatitis);
- Active malignity compromising the vital forecast at the short term;
- Septic antecedents;
- No-affiliation with the Social Security;
- Patient refusing to be recontacted by mail or telephone apart from the visits;
- Patient refusing the randomization;
- lumbar disc:
- Morbid Obesity;
- Abdomen multi operated;
- Crowned slope L5-S1 high;
- Traumatic after-effects with moderate deformations of the vertebra ;
- Symptomatic lumbar canal stenosis;
- Septic antecedents of the site to be operated;
- Great degenerative or constitutional vertebral instability ;
- Narrow lumbar channel and/or excluded and migrated lumbar slipped disc;
- Scoliosis \>8;
- Advanced articular osteoarthritis;
- Severe osteoporosis ;
- Disease of Paget, Osteomalacia, disturb metabolic osseous;
- Disease car-immune rheumatoid;
- Pregnancy;
- Badly balanced diabetes ;
- Systemic disease;
- Vascular Problem (arteritis lower limb, aortic aneurism);
- Evolutionary Hepatitis ;
- Immunodeficient Disease (of which HIV);
- No-affiliation with the Social Security;
- Patient refusing to be recontacted by mail or telephone apart from the visits;
- Patient refusing the randomization;
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT00640029
Start Date
February 1 2008
End Date
February 1 2011
Last Update
March 10 2015
Active Locations (2)
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1
Service de Chirurgie CHU Hopital Antoine Béclère
Clamart, France, 92140
2
Service de Neurochirurgie CHU Saint-Etienne
Saint-Etienne, France