Evaluation of the Prosthetic Disc Replacement (EVA)

This is an interventional treatment trial for Lumbar Degenerative Disc Disease focused on measuring Arthroplasty, Arthrodesis, Prosthesis, Disc replacement, Spine, Lumbar, Cervical, Intervertebral disk, Cervical or lumbar intervertebral disk, Degenerative pathology Read More

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 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;