Cervicobrachial NeuralgiaNCT01518582
GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study
An observational study of Cervicobrachial Neuralgia and Cervical Discopathy, run by Medicrea International at 3 sites in 2 countries.
Trial summary
This is a prospective clinical study to assess the performance of the prosthesis according to a composite success criterion. The clinical and functional results and the patient's quality of life up to 24 months of follow-up will also be recorded. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Cervicobrachial Neuralgia, Cervical Discopathy
- What is being tested?
- Cervical arthroplasty surgery with Granvia-C
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2012to Jun 2016
- Phase
- Observational
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: People with Cervicobrachial neuralgia due to symptomatic cervical discopathy
Who may be able to join
- Cervicobrachial neuralgia due to symptomatic cervical discopathy
- Presence of pain (arm or arm and neck) and/or a neurologic deficit with a radiographic confirmation (by CT, MRI, X-ray, etc.) of any of the following:
- Herniated nucleus pulposus
- Spondylosis (defined by the presence of osteophytes)
- Degenerative Disc Disease at a single level or 2-level(s) adjacent or not between C3 and C7
Who cannot join
- Asymptomatic degenerative disc disease (DDD)
- DDD of 3-levels or more
- Axial neck pain as the solitary symptom
- Severe spondylosis at the level to be treated by arthroplasty as
- Characterized by any of the following:
- Bridging osteophytes
Show all 14Show fewer
- A loss of disc height greater than 50% (compared to adjacent levels)
- Absence of motion (<2°)
- Any prior spine surgery at any cervical level, especially fusion procedure; views) for the level operated by arthroplasty
- Tumor
- Deformity or fracture of the cervical vertebrae
- Active systemic infection or infection at the operative site(s)
- Pregnant or interested in becoming pregnant in the next three years;
- Advanced emphysema, Alzheimer's disease or other medical conditions that would interfere with patient self-assessment of function, pain or quality of life
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
Tripode Hospital
Bordeaux, 33000
Clairval hospital
Marseille, 13009
About this study
Official title: The GRANVIA®-C Cervical Disc Prosthesis to Treat Symptomatic Degenerative Disc Diseases
This is a prospective clinical study to assess the performance of the prosthesis according to a composite success criterion. The clinical and functional results and the patient's quality of life up to 24 months of follow-up will also be recorded.
Granvia-c is a device NOT FDA-approved and NOT under investigation in the USA.
Read the detailed description
Anterior cervical arthrodesis has been widely used to treat the degenerative cervical spine. Although the results of ACDF are generally in the good to excellent range, interbody fusion of the cervical spine after cervical discectomy, aside from causing restriction of neck movements, also accelerates degeneration of adjacent disc levels because of the increased stress from fusion. Long-term radiographic follow-up of patients with anterior cervical fusion has demonstrated degenerative changes in the non-fused segments of the spine including disc space narrowing and osteophyte formation.
To conclude, fusion provokes a functional overload of the discs bordering the fusion that is directly correlated to the number of fused levels. Radiographic observations show a greater mechanical stress on the discs, especially in the arthrodeses involving more than one level.
Artificial discs were designed to replace the entire intervertebral disc and to preserve the physiological motion of the operated level. Several prostheses with different concepts were commercialized. Published clinical studies reported a preserved motion and improved clinical results (Neck Disability Index, Pain Visual Analogic Scale, Quality of Life).
The cervical disc prosthesis GRANVIA®-C was designed to replace the intervertebral discs of the cervical spine, to restore the disc height and to restore segmental motion.
A prospective clinical study has been set up to evaluate the performance of the prosthesis
Granvia-c is a device NOT FDA-approved and NOT under investigation in the USA.
- Conditions
- Cervicobrachial Neuralgia, Cervical Discopathy
- Being tested
- Cervical arthroplasty surgery with Granvia-C
- Keywords
- Cervicobrachial, neuralgia, symptomatic cervical discopathy
- Medical subject headings
- Brachial Plexus Neuritis, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical arthroplasty surgery with Granvia-CDevice
Discectomy and Cervical arthroplasty according to standard practice of the surgeon
| Study group | Role | What they receive |
|---|---|---|
| Radiculopathy Cervical | Radiculopathy, Cervical Receives: Device: Cervical arthroplasty surgery with Granvia-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite criterion of success
the success is defined by a composite criterion of 4 points. The surgery will be a success only if there is:
- A 15-point improvement in the NDI score from the preoperative baseline score
- Maintenance or improvement of the pre-op baseline neurological status
- Absence of secondary surgical intervention
- Absence of serious adverse event
Measured: 24Months
Secondary outcomes (8)
Radiologic evaluation of the motion
Radiologic evaluation of the motion of the operated level(s) and comparison to the motion of the adjacent levels,
Measured: Preop, 3M, 12M and 24M
Evaluation of potential peri and post-operative adverse events related or not to prosthesis.
Measured: preop, 3M, 12M, 24M
Evaluation of satisfaction
Evaluation of satisfaction with Patient Satisfaction Index
Measured: Preop, 3M, 12M and 24M
Evaluation of the time to return to activities (normal activity, work, sport activity)
Measured: preop, 3M, 12M, 24M
Evaluation of Pain
Evaluation of pain with Visual Analog Scales
Measured: Preop, 3M, 12M and 24M
cervical alignment
Radiologic evaluation of the global cervical alignment
Measured: Preop, 3M, 12M and 24M
disc height
Radiologic evaluation of the disc height of the operated level(s)
Measured: Preop, 3M, 12M and 24M
Radiologic adverse events
Radiologic evaluation of adverse events such as migration, subsidence
Measured: Preop, 3M, 12M and 24M
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicobrachial NeuralgiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicrea International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Yeh, MD, Principal investigator, Royal London Hospital, UKFrédéric Schils, MD, Principal investigator, CHC Liège, BelgiumHans Meisel, MD, Principal investigator, Halle Klinike, GermanyPatrick Guérin, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518582
- Sponsor's protocol ID
- #0802
- Status last verified
- Jun 2016
- First submitted
- 5 Jan 2012
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GRANVIA®-C Cervical Disc Prosthesis to Treat Symptomatic Degenerative Disc Diseases
- ClinicalTrials.gov ID
- NCT01518582
- Acronym / sponsor ID
- #0802
- Conditions
- Cervicobrachial Neuralgia, Cervical Discopathy
- Keywords
- Cervicobrachial, neuralgia, symptomatic cervical discopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Medicrea InternationalIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Jan 2012 (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.
This is a prospective clinical study to assess the performance of the prosthesis according to a composite success criterion. The clinical and functional results and the patient's quality of life up to 24 months of follow-up will also be recorded.
Granvia-c is a device NOT FDA-approved and NOT under investigation in the USA.
Detailed description
Anterior cervical arthrodesis has been widely used to treat the degenerative cervical spine. Although the results of ACDF are generally in the good to excellent range, interbody fusion of the cervical spine after cervical discectomy, aside from causing restriction of neck movements, also accelerates degeneration of adjacent disc levels because of the increased stress from fusion. Long-term radiographic follow-up of patients with anterior cervical fusion has demonstrated degenerative changes in the non-fused segments of the spine including disc space narrowing and osteophyte formation.
To conclude, fusion provokes a functional overload of the discs bordering the fusion that is directly correlated to the number of fused levels. Radiographic observations show a greater mechanical stress on the discs, especially in the arthrodeses involving more than one level.
Artificial discs were designed to replace the entire intervertebral disc and to preserve the physiological motion of the operated level. Several prostheses with different concepts were commercialized. Published clinical studies reported a preserved motion and improved clinical results (Neck Disability Index, Pain Visual Analogic Scale, Quality of Life).
The cervical disc prosthesis GRANVIA®-C was designed to replace the intervertebral discs of the cervical spine, to restore the disc height and to restore segmental motion.
A prospective clinical study has been set up to evaluate the performance of the prosthesis
Granvia-c is a device NOT FDA-approved and NOT under investigation in the USA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiculopathy Cervical | – | Device: Cervical arthroplasty surgery with Granvia-CRadiculopathy, Cervical |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- People with Cervicobrachial neuralgia due to symptomatic cervical discopathy
Key inclusion criteria (5 listed)
- Cervicobrachial neuralgia due to symptomatic cervical discopathy
- Presence of pain (arm or arm and neck) and/or a neurologic deficit with a radiographic confirmation (by CT, MRI, X-ray, etc.) of any of the following:
- Degenerative Disc Disease at a single level or 2-level(s) adjacent or not between C3 and C7
Key exclusion criteria (14 listed)
- Asymptomatic degenerative disc disease (DDD)
- DDD of 3-levels or more
- Axial neck pain as the solitary symptom
- Severe spondylosis at the level to be treated by arthroplasty as
- Characterized by any of the following:
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 |
|---|---|---|
| Cervical arthroplasty surgery with Granvia-CDiscectomy and Cervical arthroplasty according to standard practice of the surgeon | Device | Radiculopathy Cervical |
Primary outcome
Composite criterion of success
Time frame: 24Months
the success is defined by a composite criterion of 4 points. The surgery will be a success only if there is: * A 15-point improvement in the NDI score from the preoperative baseline score * Maintenance or improvement of the pre-op baseline neurological status * Absence of secondary surgical intervention * Absence of serious adverse event
8 secondary outcomes
Radiologic evaluation of the motion
Time frame: Preop, 3M, 12M and 24M
Evaluation of potential peri and post-operative adverse events related or not to prosthesis.
Time frame: preop, 3M, 12M, 24M
Evaluation of satisfaction
Time frame: Preop, 3M, 12M and 24M
Evaluation of the time to return to activities (normal activity, work, sport activity)
Time frame: preop, 3M, 12M, 24M
Evaluation of Pain
Time frame: Preop, 3M, 12M and 24M
cervical alignment
Time frame: Preop, 3M, 12M and 24M
disc height
Time frame: Preop, 3M, 12M and 24M
Radiologic adverse events
Time frame: Preop, 3M, 12M and 24M
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
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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.
John Yeh, MD principal investigator
Royal London Hospital, UK
Frédéric Schils, MD principal investigator
CHC Liège, Belgium
Hans Meisel, MD principal investigator
Halle Klinike, Germany
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervicobrachial Neuralgia and Cervical Discopathy, run by Medicrea International at 3 sites in 2 countries.
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 5 inclusion and 14 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: finished, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite criterion of success (time frame: 24Months). 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 28 Jun 2016; AzTrials last refreshed its copy on 30 Oct 2026.