Cervical Degenerative Disc DiseaseCERVIDISCNCT02417272
Total Disc Replacement Versus Anterior Cervical Decompression and Fusion
A study testing Surgical treatment of cervical degenerative disc disease (CP ESP®) and Surgical treatment of cervical degenerative disc disease (Axelle®) in people with Cervical Degenerative Disc Disease, run by University Hospital, Bordeaux at 3 sites in France.
Trial summary
Background : Cervical degenerative disc disease is frequent and the consequence of aging. Degeneration may lead to disc herniation. Surgery is indicated in the presence of root compression with cervicobrachial neuralgia and/or myelopathy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cervical Degenerative Disc Disease
- What is being tested?
- Surgical treatment of cervical degenerative disc disease (CP ESP®) and Surgical treatment of cervical degenerative disc disease (Axelle®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 3 sitesFrance
- Study dates
- 4 Nov 2015to 24 Nov 2021
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-60 years
- suffering from cervical disc degenerative disease (whatever the grade, level and intervertebral disc height) needing one-level surgical treatment due to either invalidating cervicobrachial nevralgia despite 3-month optimal medical treatment or neurological symptoms, with motion of surgical level at least equal to 2° degrees, and non-degenerative adjacent discs.
- Being affiliated to health insurance
- Having signed an informed consent (later than the day of inclusion and before any examination required by research)
Who cannot join
- Previous cervical traumatism and/or cervical surgery.
- Cervical degeneration defined as a Grade 4 according to modified Mehren classification and/or a Grade 5 according to Miyazaki et al classification on T2 magnetic resonance imaging (MRI), at symptomatic level and/or its adjacent levels.
- Myelopathy.
- Cervical spine instability.
- Presence of at least one major contraindication to surgery and/or general anaesthesia (ie, non-controlled coagulopathy, active infection, or serious underlying disease, auto-immune affection).
- Presence of at least one contraindication to either TDR or ACDF procedure.
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- Presence of at least one contraindication to either static/dynamic radiographs or Magnetic Resonance Imaging (MRI).
- Severe radiological osteoporosis.
- Bone metabolic disease.
- Active cancer at time of inclusion into the study.
- Chronic intake of corticosteroids or any other treatment susceptible to interfere with study conduct and/or assessment (ie, immunosuppressive drugs).
- Unlikely to comply with the requirements of the study and/or to complete the study for psychological, social, familial or geographical reasons.
- No contraception for women of childbearing age
- Pregnant or breastfeeding women
- Being under guardianship or legal supervision.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Chirurgie Orthopedique
Bordeaux, 33076
CHU Nice - Unité de Chirurgie Rachidienne
Nice, 06000
Chirurgie Orthopedique
Paris, 75013
About this study
Official title: Comparison of 2 Surgical Approaches in the Treatment of Cervical Degenerative Disc Disease: Total Disc Replacement Versus Anterior Cervical Decompression and Fusion
Background : Cervical degenerative disc disease is frequent and the consequence of aging. Degeneration may lead to disc herniation. Surgery is indicated in the presence of root compression with cervicobrachial neuralgia and/or myelopathy.
Purpose: The main objective of the study is the comparison of efficacy between total disc replacement (TDR) and Anterior Cervical Decompression and Fusion (ACDF) as surgical treatment of symptomatic cervical degenerative disc disease in term of "Success" rate, defined as preservation of adjacent segments, 24 months after surgery.
In our knowledge, there are no published data about randomized clinical trials comparing these radiological parameters (worsening of degeneration signs on static cervical spine radiographs and worsening of disc degeneration signs on MRI) at levels adjacent to surgery, between these 2 surgical approaches in patients suffering from cervical degenerative disc disease.
Read the detailed description
Surgical treatment of cervical degenerative disc disease usually consists in neural decompression followed by intervertebral space reconstruction.
ACDF consists in interbody fusion by replacing disc space with a cage packed with bone substitute, and inserted into the anterior portion of the interspace. Fusion is successful in approximately 95% of patients with good to excellent clinical results in most of them. Unfortunately, up to 25% of these patients will develop degenerative changes at adjacent levels after surgery.
TDR consists in total disc replacement with preserved segmental motion decreasing load on adjacent levels.
Worsening of radiological degeneration signs at adjacent levels seems to be an important long term prognostic factor for reoperation.
In this trial, included patients will be randomly assigned to undergo either TDR or ACDF Six visits are planned during the study: pre inclusion visit within 3 months before surgery, inclusion/randomisation the day before surgery, 3 follow up visits (45 days, 6, and 12 months after surgery) and an end of study visit 24 months after surgery (or at time of withdrawal if relevant).
- Conditions
- Cervical Degenerative Disc Disease
- Being tested
- Surgical treatment of cervical degenerative disc disease (CP ESP®), Surgical treatment of cervical degenerative disc disease (Axelle®)
- Keywords
- Total Disc Replacement, Anterior Cervical Decompression and Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatment of cervical degenerative disc disease (CP ESP®)Device
Surgical treatment of cervical degenerative disc disease (Axelle®)Device
Axelle®
| Study group | Role | What they receive |
|---|---|---|
| Total disc replacement (TDR) | Experimental | Total disc replacement with preserved segmental motion decreasing load on adjacent levels. Receives: Device: Surgical treatment of cervical degenerative disc disease (CP ESP®) |
| Anterior Cervical Decompression and Fusion (ACDF) | Experimental | Interbody fusion by replacing disc space with a cage packed with bone substitute, and inserted into the anterior portion of the interspace. Receives: Device: Surgical treatment of cervical degenerative disc disease (Axelle®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare efficacy of TDR and ACDF as surgical treatment of cervical degenerative disc disease in term of "success rate" defined as absence of radiological degenerative disease at adjacent levels
Measured: 24 months after surgery
Secondary outcomes (2)
Between-group comparison of tolerance
This measure is a composite with :
- Per- and post-operative surgery parameters
- Major complication rate
- Minor complication rate
Measured: 24 months after surgery
Between-group comparison of efficacy
This measure is a composite with :
- Cervical and radicular pain outcome as compared to preoperative status.
- Functional outcome: Neck Disability Index (NDI) and modified Prolo Economic and Functional scores as compared to preoperative status.
- Cervical radiological parameters
- Quality of life outcome as compared to preoperative status.
Measured: 45 days, 6, 12 and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study start4 Nov 2015
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Degenerative Disc DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry for Health and Solidarity, France
- Responsible party
- Sponsor
- Investigators
- Antoine BENARD, MD, Study chair, University Hospital Bordeaux, FranceOlivier GILLE, Prof, Principal investigator, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417272
- Sponsor's protocol ID
- CHUBX 2010/40
- Acronym
- CERVIDISC
- Status last verified
- Dec 2021
- First submitted
- 28 Jan 2015
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 2 Surgical Approaches in the Treatment of Cervical Degenerative Disc Disease: Total Disc Replacement Versus Anterior Cervical Decompression and Fusion
- ClinicalTrials.gov ID
- NCT02417272
- Acronym / sponsor ID
- CERVIDISC / CHUBX 2010/40
- Conditions
- Cervical Degenerative Disc Disease
- Keywords
- Total Disc Replacement, Anterior Cervical Decompression and Fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ministry for Health and Solidarity, France
- Study start
- 4 Nov 2015 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 15 Apr 2015 (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.
Background : Cervical degenerative disc disease is frequent and the consequence of aging. Degeneration may lead to disc herniation. Surgery is indicated in the presence of root compression with cervicobrachial neuralgia and/or myelopathy.
Purpose: The main objective of the study is the comparison of efficacy between total disc replacement (TDR) and Anterior Cervical Decompression and Fusion (ACDF) as surgical treatment of symptomatic cervical degenerative disc disease in term of "Success" rate, defined as preservation of adjacent segments, 24 months after surgery.
In our knowledge, there are no published data about randomized clinical trials comparing these radiological parameters (worsening of degeneration signs on static cervical spine radiographs and worsening of disc degeneration signs on MRI) at levels adjacent to surgery, between these 2 surgical approaches in patients suffering from cervical degenerative disc disease.
Detailed description
Surgical treatment of cervical degenerative disc disease usually consists in neural decompression followed by intervertebral space reconstruction.
ACDF consists in interbody fusion by replacing disc space with a cage packed with bone substitute, and inserted into the anterior portion of the interspace. Fusion is successful in approximately 95% of patients with good to excellent clinical results in most of them. Unfortunately, up to 25% of these patients will develop degenerative changes at adjacent levels after surgery.
TDR consists in total disc replacement with preserved segmental motion decreasing load on adjacent levels.
Worsening of radiological degeneration signs at adjacent levels seems to be an important long term prognostic factor for reoperation.
In this trial, included patients will be randomly assigned to undergo either TDR or ACDF Six visits are planned during the study: pre inclusion visit within 3 months before surgery, inclusion/randomisation the day before surgery, 3 follow up visits (45 days, 6, and 12 months after surgery) and an end of study visit 24 months after surgery (or at time of withdrawal if relevant).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total disc replacement (TDR) | Experimental | Device: Surgical treatment of cervical degenerative disc disease (CP ESP®)Total disc replacement with preserved segmental motion decreasing load on adjacent levels. |
| Anterior Cervical Decompression and Fusion (ACDF) | Experimental | Device: Surgical treatment of cervical degenerative disc disease (Axelle®)Interbody fusion by replacing disc space with a cage packed with bone substitute, and inserted into the anterior portion of the interspace. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18-60 years
- suffering from cervical disc degenerative disease (whatever the grade, level and intervertebral disc height) needing one-level surgical treatment due to either invalidating cervicobrachial nevralgia despite 3-month optimal medical treatment or neurological symptoms, with motion of surgical level at least equal to 2° degrees, and non-degenerative adjacent discs.
- Being affiliated to health insurance
- Having signed an informed consent (later than the day of inclusion and before any examination required by research)
Key exclusion criteria (15 listed)
- Previous cervical traumatism and/or cervical surgery.
- Cervical degeneration defined as a Grade 4 according to modified Mehren classification and/or a Grade 5 according to Miyazaki et al classification on T2 magnetic resonance imaging (MRI), at symptomatic level and/or its adjacent levels.
- Myelopathy.
- Cervical spine instability.
- Presence of at least one major contraindication to surgery and/or general anaesthesia (ie, non-controlled coagulopathy, active infection, or serious underlying disease, auto-immune affection).
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 |
|---|---|---|
| Surgical treatment of cervical degenerative disc disease (CP ESP®) | Device | Total disc replacement (TDR) |
| Surgical treatment of cervical degenerative disc disease (Axelle®)Axelle® | Device | Anterior Cervical Decompression and Fusion (ACDF) |
Primary outcome
To compare efficacy of TDR and ACDF as surgical treatment of cervical degenerative disc disease in term of "success rate" defined as absence of radiological degenerative disease at adjacent levels
Time frame: 24 months after surgery
2 secondary outcomes
Between-group comparison of tolerance
Time frame: 24 months after surgery
Between-group comparison of efficacy
Time frame: 45 days, 6, 12 and 24 months after surgery
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 3 Jan 2022.
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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.
Antoine BENARD, MD study chair
University Hospital Bordeaux, France
Olivier GILLE, Prof principal investigator
University Hospital Bordeaux, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical treatment of cervical degenerative disc disease (CP ESP®) and Surgical treatment of cervical degenerative disc disease (Axelle®) in people with Cervical Degenerative Disc Disease, run by University Hospital, Bordeaux at 3 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 4 inclusion and 15 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 3 Jan 2022. 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. 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?
To compare efficacy of TDR and ACDF as surgical treatment of cervical degenerative disc disease in term of "success rate" defined as absence of radiological degenerative disease at adjacent levels (time frame: 24 months after surgery). 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 3 Jan 2022.