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

Status: Active_not_recruiting
Location: See all (21) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Desert Institute for Spine Care
Phoenix
California
Beverly Hills Spine Surgery
Beverly Hills
Memorial Orthopaedic Surgical Group
Long Beach
Disc Sports & Spine Center
Newport Beach
UC Irvine Medical Center
Orange
Institute of Neuro Innovation
Santa Monica
St. Charles Spine Institute
Thousand Oaks
Colorado
University of Colorado School of Medicine - Department of Orthopedics
Aurora
Steadman Philipon Research Institute
Vail
Florida
Orlando Health
Orlando
Joseph Spine Institute
Tampa
Georgia
Longstreet Clinic
Gainesville
Idaho
Axis Spine
Coeur D'alene
Illinois
Carle Health
Urbana
Massachusetts
Brigham & Women's Hospital
Boston
Michigan
Michigan Orthopedic Surgeons
Southfield
Missouri
The Orthopedic Center of St. Louis
St Louis
New Jersey
Metropolitan Neurosurgery Associates - Englewood Health
Englewood
Ohio
Mayfield Clinic
Cincinnati
Texas
St. David's Healthcare
Austin
American Neurospine Institute/Medical City Frisco
Frisco
Time Frame
Start Date: 2021-07-26
Completion Date: 2026-12
Participants
Target number of participants: 156
Treatments
Experimental: 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).
Active_comparator: 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
Related Therapeutic Areas
Sponsors
Collaborators: Spinal Kinetics
Leads: Orthofix Inc.

This content was sourced from clinicaltrials.gov