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Artificial Cervical Disc
M6-C Artificial Cervical Disc for Degenerative Disc Disease
N/A
Recruiting
Led By Frank Phillips, MD
Research Sponsored by Spinal Kinetics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
You have been diagnosed with Cervical Radiculopathy
You have been diagnosed with Cervical Radiculopathy
Must not have
More than 2 specific places on the spine requiring surgery
Prior spine surgery in specific areas
Timeline
Screening 45 days
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying whether the M6-C artificial cervical disc is safe and effective compared to anterior cervical discectomy and fusion for treating 2-level cervical radiculopathy.
Who is the study for?
Adults aged 18-75 with neck or arm pain and degenerative cervical radiculopathy needing surgery at two levels from C3 to C7. Participants must have tried non-surgical treatments for at least 6 weeks without success, be able to follow the study protocol, and not have had certain previous surgeries or conditions like severe myelopathy, infections, metabolic bone diseases, severe obesity, or mental conditions affecting self-assessment.
What is being tested?
The trial is testing the safety and effectiveness of the M6-C Artificial Cervical Disc against traditional anterior cervical discectomy and fusion (ACDF) in treating two-level symptomatic cervical radiculopathy. It's a prospective study where participants are concurrently controlled across multiple centers.
What are the potential side effects?
Potential side effects may include typical surgical risks such as infection risk at the operative site, reactions to materials used in devices like titanium or polyurethane allergies if known priorly. Specific side effects related to each procedure will vary but can involve nerve damage or persistent pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 45 days1 visit
Treatment ~ Varies
Follow Up ~ 6 weeks4 visits
Screening ~ 45 days
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Operative Surgical Procedures
- Neurologic Function
- Serious Adverse Event(s)
+2 moreSecondary study objectives
FOSS Dysphagia Scale
Health-Related Quality of Life
Neck and Arm Pain
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: M6-C Artificial Cervical DiscExperimental Treatment1 Intervention
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 II: Anterior Cervical Discectomy & Fusion (ACDF)Active Control1 Intervention
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
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Spinal KineticsLead Sponsor
2 Previous Clinical Trials
466 Total Patients Enrolled
Frank Phillips, MDPrincipal InvestigatorRush University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have significant neck pain or disability, with a score of 15 or higher out of 50 on a questionnaire.My symptoms haven't improved after 6 weeks of standard treatment, or they're getting worse despite ongoing non-surgical care.I need neck surgery for pain due to disc or bone issues confirmed by scans.I need neck surgery for pain or nerve issues confirmed by scans.My symptoms did not improve after 6 weeks of standard treatment, or they are getting worse.My neck or arm pain is moderate or severe.You have neck pain that significantly affects your ability to perform daily activities, with a score of 15 or higher out of 50 on a questionnaire.My symptoms haven't improved after 6 weeks of standard treatment, or they're getting worse despite ongoing non-surgical care.My neck or arm pain is moderate or severe, scoring 4 or more out of 10.I am between 18 and 75 years old and my bones have stopped growing.You are willing and able to comply with the requirements of the protocol including follow-up requirements.You have a neck disability that affects more than 30% of your daily activities, which is measured by a questionnaire.My neck or arm pain is moderate or severe.
Timeline:
This trial has the following timeline:- Screening: It may take up to 45 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 1 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Weeks after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Anterior Cervical Discectomy & Fusion (ACDF)
- Group 2: M6-C Artificial Cervical Disc
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Cervical Disc Degeneration Patient Testimony for trial: Trial Name: NCT04982835 — N/A
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