Cervical Degenerative Disc DiseaseNCT04122248
M6-C Post Approval Study (PAS)
An observational study of Cervical Degenerative Disc Disease and Cervical Radiculopathy, run by Spinal Kinetics at 21 sites in United States.
Trial summary
The M6-C Post Approval Study is a long term follow-up study of subjects previously enrolled and treated in the M6-C Artificial Cervical Disc IDE Study. Read more about this study
- Who is it for?
- Ages 21 to 68 years
- Conditions the study is for
- Cervical Degenerative Disc Disease, Cervical Radiculopathy, Cervical Spinal Cord Compression
- What is being tested?
- standard radiographic imaging and cervical total disc replacement
- Type of treatment
- Medical device
- How many people
- 152 participants
- Where
- 21 sitesUnited States
- Study dates
- 30 Nov 2019to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects eligible for study enrollment will include subjects implanted in the M6-C™ IDE pivotal study
Who may be able to join
- Since the subjects have already been screened as part of the IDE's pivotal study, and only subjects that participated in that study make up the subject cohort for this long-term follow-up study, there are no additional inclusion criteria
Who cannot join
- Subjects who were withdrawn or withdrew consent to participate in the investigation
- Subjects who do not consent to participate in long-term follow-up or provide personal contact information to the sponsor (solely for the purposes of tracking subjects to help ensure follow-up compliance)
- Patients with terminal failures (SSI or device- or procedure-related SAE) by Month 24 and all known patient deaths in the M6-C IDE study are excluded for enrollment into the PAS
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
University of Colorado School of Medicine
Aurora, Colorado, 80045
Spine MD
Beverly Hills, California, 90210
Indiana Spine Group
Carmel, Indiana, 46032
CNSA
Charlotte, North Carolina, 28204
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
Center for Sports Medicine & Orthopedics
Chattanooga, Tennessee, 37404
Midwest Orthopedics
Chicago, Illinois, 60612
The Ohio State University - Wexner Medical Center
Columbus, Ohio, 43202
EmergeOrtho
Durham, North Carolina, 27704
ClinTech Center for Spine
Johnstown, Colorado, 80534
Memorial Orthopedic Surgical Group
Long Beach, California, 90806
West Virginia University
Morgantown, West Virginia, 26506
Yale University School of Medicine
New Haven, Connecticut, 06519
HSS
New York, New York, 10021
Desert Institute for Spine Care
Phoenix, Arizona, 85020
Texas Back Institute
Plano, Texas, 75093
Spine Institute of Lousianna
Shreveport, Louisiana, 71101
Stanford University
Stanford, California, 94305
The CORE Institute
Sun City West, Arizona, 85375
Upstate Medical University
Syracuse, New York, 13057
Medstar Hospital/Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: M6-C Artificial Cervical Disc IDE Post Approval Study
The M6-C Post Approval Study is a long term follow-up study of subjects previously enrolled and treated in the M6-C Artificial Cervical Disc IDE Study.
Read the detailed description
A prospective, concurrently controlled, multi-center pivotal study to evaluate the safety and effectiveness of the M6-C™ Artificial Cervical Disc compared to anterior cervical discectomy and fusion (ACDF) was performed in the United States under IDE #G050254. To fulfill the concurrent control design of the study, there were clinical sites that evaluated the safety and effectiveness of the M6-C™ Artificial Cervical Disc and there were other clinical sites that evaluated ACDF. Subjects in the study were treated between May 2014 and June 2016 and remain in follow-up. The M6-C™ Artificial Cervical Disc received FDA approval to market on February 6, 2019. As a condition of approval, the FDA requested that the sponsor perform a post market approval study (PAS). The subjects enrolled and remaining in the M6-C IDE pivotal study are the prospective patient population for the PAS.
- Conditions
- Cervical Degenerative Disc Disease, Cervical Radiculopathy, Cervical Spinal Cord Compression, Cervical Disc Herniation
- Being tested
- standard radiographic imaging, cervical total disc replacement
- Keywords
- artificial cervical disc arthroplasty
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard radiographic imagingOther
standard radiographic imaging
cervical total disc replacementDevice
Also called cervical disc arthroplasty, cervical artificial disc replacement
Artificial disc replacement (ADR) in the cervical spine is a minimally invasive procedure that involves removing diseased disc tissue and replacing it with an artificial disc. The artificial disc is designed to preserve the spine\'s natural motion while remaining securely attached to the surrounding vertebral bones. The goal of ADR is to help preserve the motion of the cervical spine or spinal segment after surgery, which can improve the quality of life for patients.
| Study group | Role | What they receive |
|---|---|---|
| M6-C | Subjects treated with an M6-C device Receives: Other: standard radiographic imaging; Device: cervical total disc replacement | |
| ACDF | Subjects treated with Anterior Cervical Discectomy and Fusion (ACDF) Receives: Other: standard radiographic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall subject success
A study subject will be considered an overall success if he/she meets the following criteria:
- No serious adverse event(s) classified as device or device procedure related (as determined by the CEC), and
- No subsequent surgical procedure at the index level (including revision, removal, reoperation, or supplemental fixation), and
- Maintenance or improvement in neurological function, and
- Improvement on the NDI of at least 15 points.
Measured: 10 year follow-up
Secondary outcomes (5)
Neck Disability Index (NDI)
The NDI is a patient reported outcome questionnaire for the measurement of pain and function related to cervical spine problems. A total NDI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage. Therefore, the NDI score ranges from 0% to 100%. A lower score represents less pain and dysfunction.
Measured: annually to 10 years
Neck and arm pain
A visual analogue scale is a patient reported outcome measure utilized to determine neck and arm pain on a zero to ten scale with zero being the least amount of pain and 10 the most possible pain.
Measured: annually to 10 years
SF-36 Health Survey
The SF-36 is a patient reported outcome questionnaire to measure health-related Quality of Life. An increase in score from baseline represents an improvement in health.
Measured: annually to 10 years
Patient Satisfaction
The following 5 point Likert Scale will be used to further assess subject satisfaction:
- How satisfied are you with the results of your surgery? Very Satisfied; Satisfied; Neutral; Unsatisfied; Very Unsatisfied
- All things considered, would you have the surgery again? Very likely; likely; not sure; Unlikely; Very Unlikely
- Would you recommend the surgery to a friend or family member? Very likely; likely; not sure; Unlikely; Very Unlikely
Measured: annually to 10 years
Odom's Criteria
At the 5, 7 and 10 year follow-up visits, the Investigator will rate the clinical disposition of each study subject according to Odom's Criteria[18] as follows:
Excellent: No symptoms related to cervical disease. Able to perform daily activities without limitations.
Good: Moderate symptoms related to cervical disease. Able to perform daily activities without significant limitations.
Satisfactory: Slight improvement is symptoms related to cervical disease. Significant limitations in daily activities.
Poor: No improvement in, or aggravation of, symptoms related to cervical disease. Not able to perform daily activities.
Measured: annually to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start30 Nov 2019
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spinal Kinetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122248
- Sponsor's protocol ID
- CA-C004
- Status last verified
- Jul 2025
- First submitted
- 8 Oct 2019
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- M6-C Artificial Cervical Disc IDE Post Approval Study
- ClinicalTrials.gov ID
- NCT04122248
- Acronym / sponsor ID
- CA-C004
- Conditions
- Cervical Degenerative Disc Disease, Cervical Radiculopathy, Cervical Spinal Cord Compression, Cervical Disc Herniation
- Keywords
- artificial cervical disc arthroplasty
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Spinal KineticsIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Oct 2019 (actual)
- 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.
The M6-C Post Approval Study is a long term follow-up study of subjects previously enrolled and treated in the M6-C Artificial Cervical Disc IDE Study.
Detailed description
A prospective, concurrently controlled, multi-center pivotal study to evaluate the safety and effectiveness of the M6-C™ Artificial Cervical Disc compared to anterior cervical discectomy and fusion (ACDF) was performed in the United States under IDE #G050254. To fulfill the concurrent control design of the study, there were clinical sites that evaluated the safety and effectiveness of the M6-C™ Artificial Cervical Disc and there were other clinical sites that evaluated ACDF. Subjects in the study were treated between May 2014 and June 2016 and remain in follow-up. The M6-C™ Artificial Cervical Disc received FDA approval to market on February 6, 2019. As a condition of approval, the FDA requested that the sponsor perform a post market approval study (PAS). The subjects enrolled and remaining in the M6-C IDE pivotal study are the prospective patient population for the PAS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M6-C | – | Other: standard radiographic imaging, Device: cervical total disc replacementSubjects treated with an M6-C device |
| ACDF | – | Other: standard radiographic imagingSubjects treated with Anterior Cervical Discectomy and Fusion (ACDF) |
Who may qualify
- Ages
- 21 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects eligible for study enrollment will include subjects implanted in the M6-C™ IDE pivotal study
Key inclusion criteria (1 listed)
- Since the subjects have already been screened as part of the IDE's pivotal study, and only subjects that participated in that study make up the subject cohort for this long-term follow-up study, there are no additional inclusion criteria
Key exclusion criteria (3 listed)
- Subjects who were withdrawn or withdrew consent to participate in the investigation
- Subjects who do not consent to participate in long-term follow-up or provide personal contact information to the sponsor (solely for the purposes of tracking subjects to help ensure follow-up compliance)
- Patients with terminal failures (SSI or device- or procedure-related SAE) by Month 24 and all known patient deaths in the M6-C IDE study are excluded for enrollment into the PAS
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 |
|---|---|---|
| standard radiographic imagingstandard radiographic imaging | Other | ACDF, M6-C |
| cervical total disc replacementAlso: cervical disc arthroplasty, cervical artificial disc replacementArtificial disc replacement (ADR) in the cervical spine is a minimally invasive procedure that involves removing diseased disc tissue and replacing it with an artificial disc. The artificial disc is designed to preserve the spine\'s natural motion while remaining securely attached to the surrounding vertebral bones. The goal of ADR is to help preserve the motion of the cervical spine or spinal segment after surgery, which can improve the quality of life for patients. | Device | M6-C |
Primary outcome
Overall subject success
Time frame: 10 year follow-up
A study subject will be considered an overall success if he/she meets the following criteria: * No serious adverse event(s) classified as device or device procedure related (as determined by the CEC), and * No subsequent surgical procedure at the index level (including revision, removal, reoperation, or supplemental fixation), and * Maintenance or improvement in neurological function, and * Improvement on the NDI of at least 15 points.
5 secondary outcomes
Neck Disability Index (NDI)
Time frame: annually to 10 years
Neck and arm pain
Time frame: annually to 10 years
SF-36 Health Survey
Time frame: annually to 10 years
Patient Satisfaction
Time frame: annually to 10 years
Odom's Criteria
Time frame: annually to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Degenerative Disc Disease and Cervical Radiculopathy, run by Spinal Kinetics at 21 sites in United States.
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 1 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Overall subject success (time frame: 10 year follow-up). 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 30 Jul 2025.