ACTIVE_NOT_RECRUITING

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

Conditions

Cervical Disc Degenerative Disorder artificial cervical disc degenerative disc disease total disc replacement Spinal Kinetics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-07-26

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04982835

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Principal Investigator

Jay Erturan, MD, JD

STUDY_DIRECTOR

Orthofix Inc.

Study Locations (Sites)

Desert Institute for Spine Care

Phoenix, Arizona, 85020

United States

Beverly Hills Spine Surgery

Beverly Hills, California, 90210

United States

Memorial Orthopaedic Surgical Group

Long Beach, California, 90806

United States

Disc Sports & Spine Center

Newport Beach, California, 92660

United States

UC Irvine Medical Center

Orange, California, 92868

United States

Institute of Neuro Innovation

Santa Monica, California, 90404

United States

St. Charles Spine Institute

Thousand Oaks, California, 91860

United States

University of Colorado School of Medicine - Department of Orthopedics

Aurora, Colorado, 80045

United States

Steadman Philipon Research Institute

Vail, Colorado, 81657

United States

Hartford Healthcare Bone & Joint Institute

Hartford, Connecticut, 06106

United States

Orlando Health

Orlando, Florida, 32809

United States

Joseph Spine Institute

Tampa, Florida, 33607

United States

Longstreet Clinic

Gainesville, Georgia, 30801

United States

Axis Spine

Coeur d'Alene, Idaho, 83815

United States

Carle Health

Urbana, Illinois, 61801

United States

Brigham & Women's Hospital

Boston, Massachusetts, 02115

United States

Baystate Health

Springfield, Massachusetts, 01199

United States

Michigan Orthopedic Surgeons

Southfield, Michigan, 48033

United States

The Orthopedic Center of St. Louis

St. Louis, Missouri, 63017

United States

Metropolitan Neurosurgery Associates - Englewood Health

Englewood, New Jersey, 07631

United States

Upstate Medical University

East Syracuse, New York, 13057

United States

Mayfield Clinic

Cincinnati, Ohio, 45209

United States

Ascension Texas Spine and Scoliosis

Austin, Texas, 78705

United States

St. David's Healthcare

Austin, Texas, 78705

United States

American Neurospine Institute/Medical City Frisco

Frisco, Texas, 75033

United States

University of Utah Medical Center

Salt Lake City, Utah, 84132

United States

Collaborators and Investigators

Sponsor: Spinal Kinetics

Jay Erturan, MD, JD, STUDY_DIRECTOR, Orthofix Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-26

Study Completion Date2026-12

Study Record Updates

Study Start Date2021-07-26

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

artificial cervical disc
degenerative disc disease
total disc replacement
Spinal Kinetics

Additional Relevant MeSH Terms

Cervical Disc Degenerative Disorder