Neck PainDISC-CNCT02924506
Cervical Arthroplasty "Fixed Core" Versus "Movable Core": Clinical and Radiological Impact in the Medium Term
A study testing Mobi-C prothesis and ProDisc-C prothesis in people with Neck Pain and Back Pain, run by Centre Hospitalier Régional d'Orléans at 2 sites in France.
Trial summary
Nowadays, there is no clinical and radiological study comparing two different types of mobile implants in patients requiring surgical treatment for symptomatic cervical disc disease. Thus, the choice of the ideal implant remains uncertain. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Mobi-C prothesis and ProDisc-C prothesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Feb 2015to 30 Nov 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Symptomatic cervical disc degenerative pathologies to 1 or more contiguous or non-contiguous levels C3-4 to C6-7.
- Symptoms including: Cervicobrachial neuralgia and / or Loss of root muscle strength and / or Sensory impairment and paresthesia and / or Cervical myelopathy table
- Concordant diagnosis confirmed by CT (Computerized Tomography scanner) and MRI (Magnetic Resonance Imaging) of the cervical spine
- NPDS (Neck Pain and Disability Scale) > 30
- Failure to respond to conservative medical treatment for 6 weeks or worsening symptoms despite conservative treatment
- Physical and mental fitness to ensure compliance with the protocol
- Signed informed consent
Who cannot join
- Unstable cervical spine injuries requiring fusion C1 to C7 for whatever the etiology, proven on dynamic views of the cervical spine
- Paget's disease, osteomalacia, other metabolic bone diseases
- Chronic corticosteroid use
- Active tumor pathology
- Segmental angulation < -11 ° or > 11 ° at the respective segment or adjacent segments on static images of the cervical spine
- Known allergy to Chromium, Cobalt, Mobdylene (chemical element), Polyethylene, or Titanium
Show all 9Show fewer
- History of surgery in the previous 30 days before inclusion
- History of mental illness or disability involving a "safeguard procedure justice of the person"
- Contraindications to non steroidal anti inflammatory
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHR d'ORLEANS
Orléans, 45067
Hôpital Bretonneau, CHU DE TOURS
Tours, 37044
About this study
Official title: Cervical Arthroplasty "Fixed Core" Versus "Movable Core": A Controlled Prospective Study, Clinical and Radiological Impact in the Medium Term
Nowadays, there is no clinical and radiological study comparing two different types of mobile implants in patients requiring surgical treatment for symptomatic cervical disc disease. Thus, the choice of the ideal implant remains uncertain.
The goal of this work is to compare the impact of two types of mobile implants in height drives, solicitation facets, positioning and collection of prostheses within the intervertebral spaces.
- Being tested
- Mobi-C prothesis, ProDisc-C prothesis
- Keywords
- cervical arthroplasty
- Medical subject headings
- Neck Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobi-C prothesisDevice
Mobi-C Prothesis, LDR Medical (company)
ProDisc-C prothesisDevice
ProDisc-C prothesis, Vivo Depuy Synthes (company)
| Study group | Role | What they receive |
|---|---|---|
| Fixed Core | Other | Cervical arthroplasty with fixed core prothesis Receives: Device: ProDisc-C prothesis |
| Movable Core | Other | Cervical arthroplasty with movable core prothesis Receives: Device: Mobi-C prothesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Pain and Disability Scale (NPDS) between the two groups
Measured: Baseline
Neck Pain and Disability Scale (NPDS) between the two groups
Measured: 3 months
Neck Pain and Disability Scale (NPDS) between the two groups
Measured: 1 year
Neck Pain and Disability Scale (NPDS) between the two groups
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start19 Feb 2015
- Primary completion21 Nov 2016
- Study completion30 Nov 2018
Why it stopped: Moving of coordinator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry DUFOUR, Ph, Principal investigator, CHR d'Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924506
- Sponsor's protocol ID
- CHRO-2014-04
- Acronym
- DISC-C
- Status last verified
- May 2019
- First submitted
- 3 Oct 2016
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Arthroplasty "Fixed Core" Versus "Movable Core": A Controlled Prospective Study, Clinical and Radiological Impact in the Medium Term
- ClinicalTrials.gov ID
- NCT02924506
- Acronym / sponsor ID
- DISC-C / CHRO-2014-04
- Keywords
- cervical arthroplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Moving of coordinator.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 19 Feb 2015 (actual)
- Primary completion
- 21 Nov 2016 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 5 Oct 2016 (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.
Nowadays, there is no clinical and radiological study comparing two different types of mobile implants in patients requiring surgical treatment for symptomatic cervical disc disease. Thus, the choice of the ideal implant remains uncertain.
The goal of this work is to compare the impact of two types of mobile implants in height drives, solicitation facets, positioning and collection of prostheses within the intervertebral spaces.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed Core | Other | Device: ProDisc-C prothesisCervical arthroplasty with fixed core prothesis |
| Movable Core | Other | Device: Mobi-C prothesisCervical arthroplasty with movable core prothesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- Symptomatic cervical disc degenerative pathologies to 1 or more contiguous or non-contiguous levels C3-4 to C6-7.
- Symptoms including: Cervicobrachial neuralgia and / or Loss of root muscle strength and / or Sensory impairment and paresthesia and / or Cervical myelopathy table
- Concordant diagnosis confirmed by CT (Computerized Tomography scanner) and MRI (Magnetic Resonance Imaging) of the cervical spine
- NPDS (Neck Pain and Disability Scale) > 30
Key exclusion criteria (9 listed)
- Unstable cervical spine injuries requiring fusion C1 to C7 for whatever the etiology, proven on dynamic views of the cervical spine
- Paget's disease, osteomalacia, other metabolic bone diseases
- Chronic corticosteroid use
- Active tumor pathology
- Segmental angulation < -11 ° or > 11 ° at the respective segment or adjacent segments on static images of the cervical spine
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 |
|---|---|---|
| Mobi-C prothesisMobi-C Prothesis, LDR Medical (company) | Device | Movable Core |
| ProDisc-C prothesisProDisc-C prothesis, Vivo Depuy Synthes (company) | Device | Fixed Core |
Primary outcome
Neck Pain and Disability Scale (NPDS) between the two groups
Time frame: Baseline
Neck Pain and Disability Scale (NPDS) between the two groups
Time frame: 3 months
Neck Pain and Disability Scale (NPDS) between the two groups
Time frame: 1 year
Neck Pain and Disability Scale (NPDS) between the two groups
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Moving of coordinator.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Individual participant dataSharing planned: No
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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.
Thierry DUFOUR, Ph principal investigator
CHR d'Orleans
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobi-C prothesis and ProDisc-C prothesis in people with Neck Pain and Back Pain, run by Centre Hospitalier Régional d'Orléans 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 8 inclusion and 9 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 7 May 2019. 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: Moving of coordinator.). 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?
Neck Pain and Disability Scale (NPDS) between the two groups (time frame: Baseline). The study lists 4 primary outcomes in all. 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 7 May 2019.