Study Stopped
Insuffisent recruitment
Evaluation of the Prosthetic Disc Replacement
EVA
Medico-economic Evaluation of the Prosthetic Replacement of the Lumbar and Cervical Intervertebral Disc
1 other identifier
interventional
301
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2008
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 15, 2008
CompletedFirst Posted
Study publicly available on registry
March 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedMarch 10, 2015
March 1, 2015
3 years
February 15, 2008
March 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient satisfaction at one year. Oswestry questionnaire (lumbar pathology) or NDI questionnaire (cervical pathology), SF36 score and Visual Analog Scale (Pain
1 year
Secondary Outcomes (3)
Patient satisfaction at post-interventional visit, after 45 days, at 3 months, and at 6 months
post-interventional visit, after 45 days, at 3 months, at 6 months and 1 year
Cost of the treatments
post-interventional visit, after 45 days, at 3 months, at 6 months and 1 year
Tolerance of the intervention, stability of the prosthesis
post-interventional visit, after 45 days, at 3 months, at 6 months and 1 year
Study Arms (5)
1
EXPERIMENTALCervical - Arthroplasty
2
ACTIVE COMPARATORCervical - Arthrodesis
3
EXPERIMENTALLumbar - Over 50 years - Arthroplasty
4
ACTIVE COMPARATORLumbar - Over 50 years - Arthrodesis
5
EXPERIMENTALLumbar - Under 50 years - Arthroplasty
Interventions
* SYNTHES : PRODISC-C® , PRODISC-L® * LDR : Mobi-C®, Mobidisc® * MEDTRONIC : PrestigeLP®, A-Mav®, O-Mav® * SCIENT'X : DISCOCERV®
Eligibility Criteria
You may qualify if:
- cervical disc:
- 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:
- +8 more criteria
You may not qualify if:
- 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;
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Service de Chirurgie CHU Hopital Antoine Béclère
Clamart, 92140, France
Service de Neurochirurgie CHU Saint-Etienne
Saint-Etienne, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe Cottin, MD
Assistance Publique - Hôpitaux de Paris
- PRINCIPAL INVESTIGATOR
Jacques BRUNON, MD, PhD
Saint-Etienne's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2008
First Posted
March 20, 2008
Study Start
February 1, 2008
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
March 10, 2015
Record last verified: 2015-03