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

NCT04982835•Orthofix Inc.

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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)
+16 more criteria

Locations (21)

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

Key Dates

Start Date

July 26, 2021

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2026

Last Updated

November 14, 2025

Enrollment

156

ACTUAL participants

Conditions

Cervical Disc Degenerative Disorder

Interventions

M6-C Artificial Cervical Disc

DEVICE

ACDF

DEVICE

Evaluating The Safety and Effectiveness of The NeoDisc™ Versus ACDF in Subjects With Single-Level Cervical Disc Disease

NCT00478088

Cervical Disc Degenerative Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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