Cervical Disc Degenerative DisorderNCT04982835
M6-C Artificial Cervical Disc Two-Level IDE Pivotal Study
A study testing M6-C Artificial Cervical Disc and ACDF in people with Cervical Disc Degenerative Disorder, run by Orthofix Inc. at 21 sites in United States.
Trial summary
Prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C™ artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of contiguous two-level symptomatic cervical radiculopathy at vertebral levels from C3 to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cervical Disc Degenerative Disorder
- What is being tested?
- M6-C Artificial Cervical Disc and ACDF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 21 sitesUnited States
- Study dates
- 26 Jul 2021to Dec 2026
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of degenerative cervical radiculopathy with or without spinal cord compression requiring surgical treatment at two contiguous levels from C3 to C7 demonstrated by signs and/or symptoms of disc herniation and/or osteophyte formation (e.g. neck and/or arm pain, radiculopathy, etc.) and is confirmed by patient history and radiographic studies (e.g. MRI, CT, x-rays, etc.)
- Inadequate response to conservative medical care over a period of at least 6 weeks or have the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management
- Neck Disability Index score of ≥ 30% (raw score of ≥ 15/50)
- Neck or arm pain Visual Analog Scale Score ≥ 4 on a scale of 0 to 10
- Willing and able to comply with the requirements of the protocol including follow-up requirements
- Willing and able to sign a study specific informed consent
- Skeletally mature and at least 18 years old but not older than 75 years old
Who cannot join
- More than two cervical levels requiring surgery, or two non-contiguous levels requiring surgery
- Previous anterior cervical spine surgery
- Axial neck pain as the solitary symptom
- Previous posterior cervical spine surgery (such as a posterior element decompression) that destabilizes the cervical spine
- Advanced cervical anatomical deformity (such as ankylosing spondylitis, scoliosis) at either of the operative levels or adjacent levels
- Symptomatic facet arthrosis
Show all 26Show fewer
- Less than four degrees of motion in flexion/extension at either of the index levels
- Instability as evidenced by subluxation greater than 3 millimeters at either of the index or adjacent levels as indicated on flexion/extension x-rays.
- Advanced degenerative changes (e.g., spondylosis) at either of the index vertebral levels as evidenced by bridging osteophytes, central disc height less than 4 millimeters and/or < 50% of the adjacent normal intervertebral disc, or kyphotic deformity > 11 degrees on neutral x-rays
- Severe cervical myelopathy (i.e., Nurick's Classification greater than 2)
- Active systemic infection or infection at the operative site
- Co-morbid medical conditions of the spine or upper extremities that may affect the cervical spine neurological and/or pain assessment
- Metabolic bone disease such as osteoporosis that contradicts spinal surgery
- History of an osteoporotic fracture of the spine, hip or wrist
- History of an endocrine or metabolic disorder (e.g. Paget's disease) known to affect bone and mineral metabolism
- Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
- Known allergy to titanium, stainless steels, polyurethane, polyethylene, or ethylene oxide residuals
- Fibromyalgia, Rheumatoid Arthritis (or other autoimmune disease), or a systemic disorder such as HIV or acute hepatitis B or C.
- Insulin dependent diabetes
- Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion
- Pregnant, or intend to become pregnant, during the course of the study
- Severe obesity (Body Mass Index greater than 45)
- Physical or mental condition (e.g. psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain or quality of life.
- Involved in current or pending spinal litigation where permanent disability benefits are being sought.
- Incarcerated at time of study enrollment
- Current participation in other investigational study.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
University of Colorado School of Medicine - Department of Orthopedics
Aurora, Colorado, 80045
St. David's Healthcare
Austin, Texas, 78705
Beverly Hills Spine Surgery
Beverly Hills, California, 90210
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Mayfield Clinic
Cincinnati, Ohio, 45209
Axis Spine
Coeur d'Alene, Idaho, 83815
Metropolitan Neurosurgery Associates - Englewood Health
Englewood, New Jersey, 07631
American Neurospine Institute/Medical City Frisco
Frisco, Texas, 75033
Longstreet Clinic
Gainesville, Georgia, 30801
Memorial Orthopaedic Surgical Group
Long Beach, California, 90806
Disc Sports & Spine Center
Newport Beach, California, 92660
UC Irvine Medical Center
Orange, California, 92868
Orlando Health
Orlando, Florida, 32809
Desert Institute for Spine Care
Phoenix, Arizona, 85020
Institute of Neuro Innovation
Santa Monica, California, 90404
Michigan Orthopedic Surgeons
Southfield, Michigan, 48033
The Orthopedic Center of St. Louis
St Louis, Missouri, 63017
Joseph Spine Institute
Tampa, Florida, 33607
St. Charles Spine Institute
Thousand Oaks, California, 91860
Carle Health
Urbana, Illinois, 61801
Steadman Philipon Research Institute
Vail, Colorado, 81657
About this study
Prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C™ artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of contiguous two-level symptomatic cervical radiculopathy at vertebral levels from C3 to C7 with or without spinal cord compression.
Read the detailed description
Patients will be concurrently enrolled in the M6-C treatment group and the ACDF control group. Patients should have failed at least six weeks of conservative treatment or demonstrate progressive symptoms despite continued non-operative treatment. For the study, 263 patients will undergo either a two-level cervical artificial disc procedure, or an instrumented (ACDF) procedure as per site group assignment. Patients will be evaluated clinically, radiographically, and via the collection of patient-reported outcomes at 6 Weeks, 3 Months, 6 Months, 12 Months and 24 Months. The primary endpoint is Overall Success at 24 Months.
- Conditions
- Cervical Disc Degenerative Disorder
- Being tested
- M6-C Artificial Cervical Disc, ACDF
- Keywords
- artificial cervical disc, degenerative disc disease, total disc replacement, Spinal Kinetics
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M6-C Artificial Cervical DiscDevice
An incision will be made in the front of the neck and the damaged disc located between cervical vertebrae (neck bones) will be removed so that the M6-C artificial cervical disc can be placed into the space where the damaged disc was removed. This procedure will be performed using x-ray technology (fluoroscopy) guide the surgeon in placement of the M6-C in between the cervical vertebrae. This process will be repeated to replace the second damaged disc.
ACDFDevice
One of four FDA-approved cervical plate systems will be used for the ACDF. An incision will be made in the front of the neck and the damaged disc located between cervical vertebrae (neck bones) will be removed. Then, a piece of donor bone will be placed in the space where the damaged disc was removed and a metal plate will be screwed into the bones above and below the disc. This procedure will be performed using x-ray technology (fluoroscopy) to guide the surgeon in the placement of the cervical plate system. This process will be repeated to treat the other damaged disc.
| Study group | Role | What they receive |
|---|---|---|
| M6-C Artificial Cervical Disc | Experimental | The M6-C is an investigational device composed of two outer and inner endplates made of titanium with a polycarbonate urethane nucleus (plastic center) and a polyethylene fiber annulus (strong thread-like binding). Around the polyethylene annulus is a polyurethane sheath (plastic cover). The outer endplates have keels to anchor the disc to bone. The outer endplates and keels are both coated with a titanium plasma spray. The M6-C is provided in two heights (6mm and 7mm) and four footprints (Medium, Medium Long, Large, Large Long). Receives: Device: M6-C Artificial Cervical Disc |
| Anterior Cervical Discectomy & Fusion (ACDF) | Active comparator | ACDF will be performed using one of four FDA-approved anterior cervical plate systems and corticocancellous allograft bone. The four plating systems used in this study are:
* Orthofix CETRA Anterior Cervical Plate System
* Medtronic Sofamor/Danek Venture Anterior Cervical Plate System
* DePuy Synthes: SKYLINE Anterior Cervical Plate System
* Stryker Aviator Anterior Cervical Plating System Receives: Device: ACDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Impairment - Neck Disability Index Score (NDI)
Change in condition-specific functional impairment will be evaluated using a 10 item NDI outcomes questionnaire to assess change in the functional impairment score. NDI scores range from 0-50 (0%-100%) with higher scores demonstrating greater disability.
Measured: 24 Month
Overall Participant Success Rate (M6-C Artificial Cervical Disc)
- Participant success is a composite endpoint of all of the listed Primary Outcome Measures.
Measured: 24 Month
- Serious Adverse Event(s)
No serious adverse events classified as device or device procedure related (as determined by the Clinical Events Committee).
Measured: 24 Month
- Additional Surgical Intervention
No supplemental surgical procedure at the index level(s) including supplemental fixation, revision and/or device removal.
Measured: 24 Month
- Neurologic Function
Maintenance or improvement in neurological function as determined by Clinical Events Committee review of neurological exam results.
Measured: 24 Month
Secondary outcomes (7)
Neck and Arm Pain
Change in severity of neck and arm pain will be evaluated on a 10-cm Visual Analog Scale (VAS). Zero = no pain, 10 = worst possible pain.
Measured: 24 Month
Health-Related Quality of Life
Maintenance or improvement of health-related quality of life will be evaluated using the SF-12v2 Health Survey.
Measured: 24 Month
Radiographic Assessments
Quantitative and qualitative assessments compared to baseline evaluating surgical success outcomes for both cohorts.
Measured: 24 Month
FOSS Dysphagia Scale
The five-stage Functional Outcome Swallowing Scale (FOSS) will be used to determine presence/absence of post-operative oropharyngeal dysphagia and severity of the disorder and outcome. On the 0 to 4 FOSS scale, 0=normal; asymptomatic, whereas 5=severe dysphagia; nonoral feeding.
Measured: 24 Month
Odom's Criteria
Physician assessment of the clinical disposition of a participant at two-years using the 4-point rating scale (excellent, good, satisfactory, poor) for assessing the clinical outcome after cervical spine surgery.
Measured: 24 Month
Patient Satisfaction
A brief Participant Satisfaction Questionnaire (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied) regarding the outcome of their surgery at two-years.
Measured: 24 Month
Pain Medication Usage
Change in usage of post-operative pain medications specifically prescribed for cervical spine will be documented.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start26 Jul 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc Degenerative DisorderStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthofix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Spinal Kinetics
- Responsible party
- Sponsor
- Investigators
- Jay Erturan, MD, JD, Study director, Orthofix Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982835
- Sponsor's protocol ID
- CA-C003-Pivotal
- Status last verified
- Nov 2025
- First submitted
- 17 Sep 2019
- Last updated
- 14 Nov 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 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- M6-C Artificial Cervical Disc Two-Level IDE Pivotal Study
- ClinicalTrials.gov ID
- NCT04982835
- Acronym / sponsor ID
- CA-C003-Pivotal
- Conditions
- Cervical Disc Degenerative Disorder
- Keywords
- artificial cervical disc, degenerative disc disease, total disc replacement, Spinal Kinetics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Orthofix Inc.Industry (pharma, biotech, devices)
- Collaborators
- Spinal Kinetics
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Jul 2021 (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.
Prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C™ artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of contiguous two-level symptomatic cervical radiculopathy at vertebral levels from C3 to C7 with or without spinal cord compression.
Detailed description
Patients will be concurrently enrolled in the M6-C treatment group and the ACDF control group. Patients should have failed at least six weeks of conservative treatment or demonstrate progressive symptoms despite continued non-operative treatment. For the study, 263 patients will undergo either a two-level cervical artificial disc procedure, or an instrumented (ACDF) procedure as per site group assignment. Patients will be evaluated clinically, radiographically, and via the collection of patient-reported outcomes at 6 Weeks, 3 Months, 6 Months, 12 Months and 24 Months. The primary endpoint is Overall Success at 24 Months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M6-C Artificial Cervical Disc | Experimental | Device: M6-C Artificial Cervical DiscThe M6-C is an investigational device composed of two outer and inner endplates made of titanium with a polycarbonate urethane nucleus (plastic center) and a polyethylene fiber annulus (strong thread-like binding). Around the polyethylene annulus is a polyurethane sheath (plastic cover). The outer endplates have keels to anchor the disc to bone. The outer endplates and keels are both coated with a titanium plasma spray. The M6-C is provided in two heights (6mm and 7mm) and four footprints (Medium, Medium Long, Large, Large Long). |
| Anterior Cervical Discectomy & Fusion (ACDF) | Active comparator | Device: ACDFACDF will be performed using one of four FDA-approved anterior cervical plate systems and corticocancellous allograft bone. The four plating systems used in this study are: * Orthofix CETRA Anterior Cervical Plate System * Medtronic Sofamor/Danek Venture Anterior Cervical Plate System * DePuy Synthes: SKYLINE Anterior Cervical Plate System * Stryker Aviator Anterior Cervical Plating System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of degenerative cervical radiculopathy with or without spinal cord compression requiring surgical treatment at two contiguous levels from C3 to C7 demonstrated by signs and/or symptoms of disc herniation and/or osteophyte formation (e.g. neck and/or arm pain, radiculopathy, etc.) and is confirmed by patient history and radiographic studies (e.g. MRI, CT, x-rays, etc.)
- Inadequate response to conservative medical care over a period of at least 6 weeks or have the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management
- Neck Disability Index score of ≥ 30% (raw score of ≥ 15/50)
- Neck or arm pain Visual Analog Scale Score ≥ 4 on a scale of 0 to 10
- Willing and able to comply with the requirements of the protocol including follow-up requirements
Key exclusion criteria (26 listed)
- More than two cervical levels requiring surgery, or two non-contiguous levels requiring surgery
- Previous anterior cervical spine surgery
- Axial neck pain as the solitary symptom
- Previous posterior cervical spine surgery (such as a posterior element decompression) that destabilizes the cervical spine
- Advanced cervical anatomical deformity (such as ankylosing spondylitis, scoliosis) at either of the operative levels or adjacent levels
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 |
|---|---|---|
| M6-C Artificial Cervical DiscAn incision will be made in the front of the neck and the damaged disc located between cervical vertebrae (neck bones) will be removed so that the M6-C artificial cervical disc can be placed into the space where the damaged disc was removed. This procedure will be performed using x-ray technology (fluoroscopy) guide the surgeon in placement of the M6-C in between the cervical vertebrae. This process will be repeated to replace the second damaged disc. | Device | M6-C Artificial Cervical Disc |
| ACDFOne of four FDA-approved cervical plate systems will be used for the ACDF. An incision will be made in the front of the neck and the damaged disc located between cervical vertebrae (neck bones) will be removed. Then, a piece of donor bone will be placed in the space where the damaged disc was removed and a metal plate will be screwed into the bones above and below the disc. This procedure will be performed using x-ray technology (fluoroscopy) to guide the surgeon in the placement of the cervical plate system. This process will be repeated to treat the other damaged disc. | Device | Anterior Cervical Discectomy & Fusion (ACDF) |
Primary outcome
Functional Impairment - Neck Disability Index Score (NDI)
Time frame: 24 Month
Change in condition-specific functional impairment will be evaluated using a 10 item NDI outcomes questionnaire to assess change in the functional impairment score. NDI scores range from 0-50 (0%-100%) with higher scores demonstrating greater disability.
Overall Participant Success Rate (M6-C Artificial Cervical Disc)
Time frame: 24 Month
- Participant success is a composite endpoint of all of the listed Primary Outcome Measures.
- Serious Adverse Event(s)
Time frame: 24 Month
No serious adverse events classified as device or device procedure related (as determined by the Clinical Events Committee).
- Additional Surgical Intervention
Time frame: 24 Month
No supplemental surgical procedure at the index level(s) including supplemental fixation, revision and/or device removal.
- Neurologic Function
Time frame: 24 Month
Maintenance or improvement in neurological function as determined by Clinical Events Committee review of neurological exam results.
7 secondary outcomes
Neck and Arm Pain
Time frame: 24 Month
Health-Related Quality of Life
Time frame: 24 Month
Radiographic Assessments
Time frame: 24 Month
FOSS Dysphagia Scale
Time frame: 24 Month
Odom's Criteria
Time frame: 24 Month
Patient Satisfaction
Time frame: 24 Month
Pain Medication Usage
Time frame: 24 Months
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 14 Nov 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.
Jay Erturan, MD, JD study director
Orthofix Inc.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M6-C Artificial Cervical Disc and ACDF in people with Cervical Disc Degenerative Disorder, run by Orthofix Inc. 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 7 inclusion and 26 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 14 Nov 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?
Functional Impairment - Neck Disability Index Score (NDI) (time frame: 24 Month). The study lists 5 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 14 Nov 2025.