New artificial disc could replace fusion for neck pain

NCT ID NCT04982835

Disease control Sponsor: Orthofix Inc. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new artificial disc (M6-C) for people with two damaged discs in their neck. It compares the disc to standard fusion surgery. The goal is to see if the artificial disc can safely improve neck function and reduce pain. About 156 adults with neck and arm pain from disc disease are taking part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: M6-C artificial cervical disc (a medical device)
What this could lead to: If successful, this could offer a motion-preserving alternative to spinal fusion for people with two-level disc disease, potentially reducing pain and improving neck function.
What could go wrong: This is a mid-stage study with 156 participants, so results may not apply to everyone. Device-related risks include implant failure, infection, or need for additional surgery.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

156 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.

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Conditions

The condition(s) this trial relates to.

cervical disk degenerative disorder intervertebral disk degenerative disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical disc degenerative disorder

Contacts and locations

Locations

American Neurospine Institute/Medical City Frisco

Frisco, Texas, 75033, United States
Axis Spine

Coeur d'Alene, Idaho, 83815, United States
Beverly Hills Spine Surgery

Beverly Hills, California, 90210, United States
Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States
Carle Health

Urbana, Illinois, 61801, United States
Desert Institute for Spine Care

Phoenix, Arizona, 85020, United States
Disc Sports & Spine Center

Newport Beach, California, 92660, United States
Institute of Neuro Innovation

Santa Monica, California, 90404, United States
Joseph Spine Institute

Tampa, Florida, 33607, United States
Longstreet Clinic

Gainesville, Georgia, 30801, United States
Mayfield Clinic

Cincinnati, Ohio, 45209, United States
Memorial Orthopaedic Surgical Group

Long Beach, California, 90806, United States
Metropolitan Neurosurgery Associates - Englewood Health

Englewood, New Jersey, 07631, United States
Michigan Orthopedic Surgeons

Southfield, Michigan, 48033, United States
Orlando Health

Orlando, Florida, 32809, United States
St. Charles Spine Institute

Thousand Oaks, California, 91860, United States
St. David's Healthcare

Austin, Texas, 78705, United States
Steadman Philipon Research Institute

Vail, Colorado, 81657, United States
The Orthopedic Center of St. Louis

St Louis, Missouri, 63017, United States
UC Irvine Medical Center

Orange, California, 92868, United States
University of Colorado School of Medicine - Department of Orthopedics

Aurora, Colorado, 80045, United States

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