M6-C Artificial Cervical Disc Two-Level IDE Pivotal Study

NCT04982835 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CA-C003-Pivotal
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 21

Brief 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 C7 with or without spinal cord compression.

Conditions

Cervical Disc Degenerative Disorder

Keywords

artificial cervical disc; degenerative disc disease; total disc replacement; Spinal Kinetics

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  24 Month

• - Serious Adverse Event(s)

  No serious adverse events classified as device or device procedure related (as determined by the Clinical Events Committee).

  24 Month

• - Additional Surgical Intervention

  No supplemental surgical procedure at the index level(s) including supplemental fixation, revision and/or device removal.

  24 Month

• - Neurologic Function

  Maintenance or improvement in neurological function as determined by Clinical Events Committee review of neurological exam results.

  24 Month

Secondary Outcomes (7)

• Neck and Arm Pain

  24 Month

• Health-Related Quality of Life

  24 Month

• Radiographic Assessments

  24 Month

• FOSS Dysphagia Scale

  24 Month

• Odom's Criteria

  24 Month

Study Arms (2)

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).

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

Device: ACDF

Interventions

M6-C Artificial Cervical Disc DEVICE

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.

M6-C Artificial Cervical Disc

ACDF DEVICE

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.

Anterior Cervical Discectomy & Fusion (ACDF)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthofix Inc.: lead
• Spinal Kinetics: collaborator

Study Sites (21)

Desert Institute for Spine Care

Phoenix, Arizona, 85020, United States

Location

Beverly Hills Spine Surgery

Beverly Hills, California, 90210, United States

Location

Memorial Orthopaedic Surgical Group

Long Beach, California, 90806, United States

Location

Disc Sports & Spine Center

Newport Beach, California, 92660, United States

Location

UC Irvine Medical Center

Orange, California, 92868, United States

Location

Institute of Neuro Innovation

Santa Monica, California, 90404, United States

Location

St. Charles Spine Institute

Thousand Oaks, California, 91860, United States

Location

University of Colorado School of Medicine - Department of Orthopedics

Aurora, Colorado, 80045, United States

Location

Steadman Philipon Research Institute

Vail, Colorado, 81657, United States

Location

Orlando Health

Orlando, Florida, 32809, United States

Location

Joseph Spine Institute

Tampa, Florida, 33607, United States

Location

Longstreet Clinic

Gainesville, Georgia, 30801, United States

Location

Axis Spine

Coeur d'Alene, Idaho, 83815, United States

Location

Carle Health

Urbana, Illinois, 61801, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Michigan Orthopedic Surgeons

Southfield, Michigan, 48033, United States

Location

The Orthopedic Center of St. Louis

St Louis, Missouri, 63017, United States

Location

Metropolitan Neurosurgery Associates - Englewood Health

Englewood, New Jersey, 07631, United States

Location

Mayfield Clinic

Cincinnati, Ohio, 45209, United States

Location

St. David's Healthcare

Austin, Texas, 78705, United States

Location

American Neurospine Institute/Medical City Frisco

Frisco, Texas, 75033, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Jay Erturan, MD, JD

  Orthofix Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Participants will be assigned a treatment group by enrolling site and will not be blinded to the treatment group assignment before their surgery. Investigator, and site will not be blinded to treatment assignment due to the need to prepare for the respective surgery associated with the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: July 29, 2021
• Study Start: July 26, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)