Lumbar Degenerative Disc DiseaseEVANCT00640029
Evaluation of the Prosthetic Disc Replacement
A study testing Arthrodesis and Arthroplasty (PRODISC-C® , PRODISC-L®, Mobi-C®, Mobidisc®, PrestigeLP®, A-Mav®, O-Mav®, DISCOCERV®) in people with Lumbar Degenerative Disc Disease and Cervical Degenerative Disc Disease, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Lumbar Degenerative Disc Disease, Cervical Degenerative Disc Disease, Kyphosis
- What is being tested?
- Arthrodesis and Arthroplasty (PRODISC-C® , PRODISC-L®, Mobi-C®, Mobidisc®, PrestigeLP®, A-Mav®, O-Mav®, DISCOCERV®)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2008to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
Who cannot join
- 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°));
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- 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;
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de Chirurgie CHU Hopital Antoine Béclère
Clamart, 92140
Service de Neurochirurgie CHU Saint-Etienne
Saint-Etienne
About this study
Official title: Medico-economic Evaluation of the Prosthetic Replacement of the Lumbar and Cervical Intervertebral Disc
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.
Read more
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.
Read the 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 pathology, a comparative randomized multi-site study of the medico-economic evaluation of the prosthesis implementation versus arthrodesis, the standard treatment, will be realised , for patients from 20 to 55 years old, within very rigorous exclusion and inclusion criteria.
For the lumbar pathology, a comparative randomized multi-site study of the medico-economic evaluation of the prosthesis implementation versus arthrodesis, the standard treatment, will be realized , for patients from 50 to 65 years old, within acute exclusion and inclusion criteria.
For patients under 50 years old, randomization is not used as arthroplasty offers very good results. By these young patients, a cohort study will thus be realized.
Patients with degenerative discal disease at one or more levels will be recruited in 17 sites in France :
- 3 sites in ASSITANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
- 14 sites in France outside AP-HP.
The study will have 3 parts :
- Cervical pathology : 500 patients divided on 250 arthroplasties and 250 arthrodeses.
- Lumbar pathology : 525 patients divided according to their age:
- over 50 years old : randomization in 175 lumbar arthroplasties and 175 lumbar arthrodeses.
- until 50 years old : cohort study : 175 lumbar arthroplasties.
This study will last 3 years : a 2 year-period of inclusion , and a post interventional one year-follow-up period for each included patient.
The duration of the participation in the study for each patient is one year.
7 evaluations will be realized for each patient : pre-interventional visit, intervention, post-interventional visit, visit at 45 days, visit at 3 months, visit at 6 months and visit at one year.
Each visit will comprise different exams and observations.
The criterion of principle judgement will be the quality of life measured as follows :
- For the lumbar pathology, the Oswestry Low Back Pain Disability Questionnaire, the SF36 Questionnaire, the Visual Analog Scale (Pain), at each visit.
- For the cervical pathology : the NDI score, the SF36 Questionnaire, the Visual Analog Scale (Pain), at each visit.
The secondary criteria will be medico-economical and clinical too. Arthrodesis and Arthroplasty will be compared in terms of:
- anatomical results of the intervention
- intervention tolerance
- wear (estimated by the discal height)
- costs of the intervention.
- Being tested
- Arthrodesis, Arthroplasty (PRODISC-C® , PRODISC-L®, Mobi-C®, Mobidisc®, PrestigeLP®, A-Mav®, O-Mav®, DISCOCERV®)
- Keywords
- Arthroplasty, Arthrodesis, Prosthesis, Disc replacement, Spine, Lumbar, Cervical, Intervertebral disk, Cervical or lumbar intervertebral disk, Degenerative pathology
- Medical subject headings
- Intervertebral Disc Degeneration, Kyphosis, Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthrodesisProcedure or surgery
- posterior,
- anterior,
- circumference approach
Arthroplasty (PRODISC-C® , PRODISC-L®, Mobi-C®, Mobidisc®, PrestigeLP®, A-Mav®, O-Mav®, DISCOCERV®)Device
- SYNTHES : PRODISC-C® , PRODISC-L®
- LDR : Mobi-C®, Mobidisc®
- MEDTRONIC : PrestigeLP®, A-Mav®, O-Mav®
- SCIENT'X : DISCOCERV®
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cervical - Arthroplasty Receives: Device: Arthroplasty (PRODISC-C® , PRODISC-L®, Mobi-C®, Mobidisc®, PrestigeLP®, A-Mav®, O-Mav®, DISCOCERV®) |
| 2 | Active comparator | Cervical - Arthrodesis Receives: Procedure: Arthrodesis |
| 3 | Experimental | Lumbar - Over 50 years - Arthroplasty Receives: Device: Arthroplasty (PRODISC-C® , PRODISC-L®, Mobi-C®, Mobidisc®, PrestigeLP®, A-Mav®, O-Mav®, DISCOCERV®) |
| 4 | Active comparator | Lumbar - Over 50 years - Arthrodesis Receives: Procedure: Arthrodesis |
| 5 | Experimental | Lumbar - Under 50 years - Arthroplasty Receives: Device: Arthroplasty (PRODISC-C® , PRODISC-L®, Mobi-C®, Mobidisc®, PrestigeLP®, A-Mav®, O-Mav®, DISCOCERV®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction at one year. Oswestry questionnaire (lumbar pathology) or NDI questionnaire (cervical pathology), SF36 score and Visual Analog Scale (Pain
Measured: 1 year
Secondary outcomes (3)
Patient satisfaction at post-interventional visit, after 45 days, at 3 months, and at 6 months
Measured: post-interventional visit, after 45 days, at 3 months, at 6 months and 1 year
Cost of the treatments
Measured: post-interventional visit, after 45 days, at 3 months, at 6 months and 1 year
Tolerance of the intervention, stability of the prosthesis
Measured: post-interventional visit, after 45 days, at 3 months, at 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Insuffisent recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Degenerative Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Cottin, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisJacques BRUNON, MD, PhD, Principal investigator, Saint-Etienne's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640029
- Sponsor's protocol ID
- P060409
- Acronym
- EVA
- Status last verified
- Mar 2015
- First submitted
- 15 Feb 2008
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Evaluation of the Prosthetic Replacement of the Lumbar and Cervical Intervertebral Disc
- ClinicalTrials.gov ID
- NCT00640029
- Acronym / sponsor ID
- EVA / P060409
- Keywords
- Arthroplasty, Arthrodesis, Prosthesis, Disc replacement, Spine, Lumbar, Cervical, Intervertebral disk
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insuffisent recruitment
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 20 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 pathology, a comparative randomized multi-site study of the medico-economic evaluation of the prosthesis implementation versus arthrodesis, the standard treatment, will be realised , for patients from 20 to 55 years old, within very rigorous exclusion and inclusion criteria.
For the lumbar pathology, a comparative randomized multi-site study of the medico-economic evaluation of the prosthesis implementation versus arthrodesis, the standard treatment, will be realized , for patients from 50 to 65 years old, within acute exclusion and inclusion criteria.
For patients under 50 years old, randomization is not used as arthroplasty offers very good results. By these young patients, a cohort study will thus be realized.
Patients with degenerative discal disease at one or more levels will be recruited in 17 sites in France :
- 3 sites in ASSITANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
- 14 sites in France outside AP-HP.
The study will have 3 parts :
- Cervical pathology : 500 patients divided on 250 arthroplasties and 250 arthrodeses.
- Lumbar pathology : 525 patients divided according to their age:
- over 50 years old : randomization in 175 lumbar arthroplasties and 175 lumbar arthrodeses.
- until 50 years old : cohort study : 175 lumbar arthroplasties.
This study will last 3 years : a 2 year-period of inclusion , and a post interventional one year-follow-up period for each included patient.
The duration of the participation in the study for each patient is one year.
7 evaluations will be realized for each patient : pre-interventional visit, intervention, post-interventional visit, visit at 45 days, visit at 3 months, visit at 6 months and visit at one year.
Each visit will comprise different exams and observations.
The criterion of principle judgement will be the quality of life measured as follows :
- For the lumbar pathology, the Oswestry Low Back Pain Disability Questionnaire, the SF36 Questionnaire, the Visual Analog Scale (Pain), at each visit.
- For the cervical pathology : the NDI score, the SF36 Questionnaire, the Visual Analog Scale (Pain), at each visit.
The secondary criteria will be medico-economical and clinical too. Arthrodesis and Arthroplasty will be compared in terms of:
- anatomical results of the intervention
- intervention tolerance
- wear (estimated by the discal height)
- costs of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Arthroplasty (PRODISC-C® , PRODISC-L®, Mobi-C®, Mobidisc®, PrestigeLP®, A-Mav®, O-Mav®, DISCOCERV®)Cervical - Arthroplasty |
| 2 | Active comparator | Procedure: ArthrodesisCervical - Arthrodesis |
| 3 | Experimental | Device: Arthroplasty (PRODISC-C® , PRODISC-L®, Mobi-C®, Mobidisc®, PrestigeLP®, A-Mav®, O-Mav®, DISCOCERV®)Lumbar - Over 50 years - Arthroplasty |
| 4 | Active comparator | Procedure: ArthrodesisLumbar - Over 50 years - Arthrodesis |
| 5 | Experimental | Device: Arthroplasty (PRODISC-C® , PRODISC-L®, Mobi-C®, Mobidisc®, PrestigeLP®, A-Mav®, O-Mav®, DISCOCERV®)Lumbar - Under 50 years - Arthroplasty |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- cervical disc:
- lumbar disc:
Key exclusion criteria (42 listed)
- cervical disc:
- lumbar disc:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthrodesis* posterior, * anterior, * circumference approach | Procedure or surgery | 2, 4 |
| Arthroplasty (PRODISC-C® , PRODISC-L®, Mobi-C®, Mobidisc®, PrestigeLP®, A-Mav®, O-Mav®, DISCOCERV®)* SYNTHES : PRODISC-C® , PRODISC-L® * LDR : Mobi-C®, Mobidisc® * MEDTRONIC : PrestigeLP®, A-Mav®, O-Mav® * SCIENT'X : DISCOCERV® | Device | 1, 3, 5 |
Primary outcome
Patient satisfaction at one year. Oswestry questionnaire (lumbar pathology) or NDI questionnaire (cervical pathology), SF36 score and Visual Analog Scale (Pain
Time frame: 1 year
3 secondary outcomes
Patient satisfaction at post-interventional visit, after 45 days, at 3 months, and at 6 months
Time frame: post-interventional visit, after 45 days, at 3 months, at 6 months and 1 year
Cost of the treatments
Time frame: post-interventional visit, after 45 days, at 3 months, at 6 months and 1 year
Tolerance of the intervention, stability of the prosthesis
Time frame: post-interventional visit, after 45 days, at 3 months, at 6 months and 1 year
Results and safety
The study was stopped early (reason given: Insuffisent recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Cottin, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Jacques BRUNON, MD, PhD principal investigator
Saint-Etienne's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrodesis and Arthroplasty (PRODISC-C® , PRODISC-L®, Mobi-C®, Mobidisc®, PrestigeLP®, A-Mav®, O-Mav®, DISCOCERV®) in people with Lumbar Degenerative Disc Disease and Cervical Degenerative Disc Disease, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insuffisent recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction at one year. Oswestry questionnaire (lumbar pathology) or NDI questionnaire (cervical pathology), SF36 score and Visual Analog Scale (Pain (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.