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

NCT ID: NCT04982835

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-26
• Study Completion Date: 2026-12-31

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.

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

Keywords

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

M6-C Artificial Cervical Disc

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).

Group Type: EXPERIMENTAL

M6-C Artificial Cervical Disc

Intervention Type: 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.

Anterior Cervical Discectomy & Fusion (ACDF)

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

Group Type: ACTIVE_COMPARATOR

ACDF

Intervention Type: 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.

Interventions

M6-C Artificial Cervical Disc

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.

Intervention Type: DEVICE

ACDF

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spinal Kinetics

INDUSTRY

Sponsor Role: collaborator

Orthofix Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay Erturan, MD, JD

Role: STUDY_DIRECTOR

Orthofix Inc.

Locations

Desert Institute for Spine Care

Phoenix, Arizona, United States

Beverly Hills Spine Surgery

Beverly Hills, California, United States

Memorial Orthopaedic Surgical Group

Long Beach, California, United States

Disc Sports & Spine Center

Newport Beach, California, United States

UC Irvine Medical Center

Orange, California, United States

Institute of Neuro Innovation

Santa Monica, California, United States

St. Charles Spine Institute

Thousand Oaks, California, United States

University of Colorado School of Medicine - Department of Orthopedics

Aurora, Colorado, United States

Steadman Philipon Research Institute

Vail, Colorado, United States

Orlando Health

Orlando, Florida, United States

Joseph Spine Institute

Tampa, Florida, United States

Longstreet Clinic

Gainesville, Georgia, United States

Axis Spine

Coeur d'Alene, Idaho, United States

Carle Health

Urbana, Illinois, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Michigan Orthopedic Surgeons

Southfield, Michigan, United States

The Orthopedic Center of St. Louis

St Louis, Missouri, United States

Metropolitan Neurosurgery Associates - Englewood Health

Englewood, New Jersey, United States

Mayfield Clinic

Cincinnati, Ohio, United States

St. David's Healthcare

Austin, Texas, United States

American Neurospine Institute/Medical City Frisco

Frisco, Texas, United States

Countries

United States

Other Identifiers

CA-C003-Pivotal

Identifier Type: -

Identifier Source: org_study_id