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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
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
Timeline
Screening 45 days
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
My neck or arm pain is moderate or severe.
Select...
I need neck surgery for pain or nerve issues confirmed by scans.
Select...
My symptoms haven't improved after 6 weeks of standard treatment, or they're getting worse despite ongoing non-surgical care.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Operative Surgical Procedures
- Neurologic Function
- Serious Adverse Event(s)
+2 moreSecondary outcome measures
FOSS Dysphagia Scale
Health-Related Quality of Life
Neck and Arm Pain
+4 moreTrial 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:- I need neck surgery for pain due to disc or bone issues confirmed by scans.My symptoms did not improve after 6 weeks of standard treatment, or they are getting worse.I need neck surgery for pain or nerve issues confirmed by scans.You have significant neck pain or disability, with a score of 15 or higher out of 50 on a questionnaire.I am between 18 and 75 years old and my bones have stopped growing.I have had surgery on the front part of my neck spine before.I have back pain due to facet joint arthritis.My spine shows more than 3mm movement in certain areas on bending x-rays.I have severe spine wear at certain levels shown by specific changes on X-rays.My spinal cord condition severely limits my ability to walk.I currently have an infection in my body or at a surgery site.I have a condition like Paget's disease that affects bone health.I am on medications that could affect healing, like steroids.I have fibromyalgia, rheumatoid arthritis, another autoimmune disease, HIV, or acute hepatitis B or C.I use insulin to manage my diabetes.I do not have a serious health condition that could interfere with the study.My only symptom is neck pain.My symptoms haven't improved after 6 weeks of standard treatment, or they're getting worse despite ongoing non-surgical care.I had neck surgery that made my spine less stable.I have had a fracture in my spine, hip, or wrist due to osteoporosis.My BMI is over 45, indicating severe obesity.I have a severe spine deformity near my neck area.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 have a bone condition like osteoporosis that prevents spinal surgery.I have conditions affecting my spine or arms that could change neck nerve or pain tests.I have limited movement in my spine.You are willing and able to comply with the requirements of the protocol including follow-up requirements.I am between 18 and 75 years old and my bones have stopped growing.I need surgery on more than two levels of my neck, or on two levels that are not next to each other.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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there numerous sites in this state where the trial is being conducted?
"This clinical trial is taking place at 13 medical centres, such as Orlando Health in Orlando, Brigham & Women's Hospital in Boston and Longstreet Clinic in Gainesville."
Answered by AI
Am I eligible to partake in this medical experiment?
"This study, which has a total enrolment of 263 people, is accepting patients between the ages 18 to 75 who have intervertebral disc degeneration."
Answered by AI
Are there any opportunities for prospective participants to join this scientific investigation?
"Clinicaltrials.gov attests to this clinical trial's current active recruitment status, which was initiated on July 26th 2021 and most recently updated on November 3rd 2022."
Answered by AI
Does this particular medical trial accept enrollees beyond age 60?
"This clinical trial is restricted to participants aged 18-75. Those younger or older have 2 and 58 trials respectively which may be appropriate for them."
Answered by AI
What is the upper limit of individuals included in this clinical trial?
"Spinal Kinetics is the sponsor of this medical trial, which necessitates 263 participants that satisfy the pre-defined inclusion criteria. The research will be conducted at various sites such as Orlando Health (Orlando, Florida) and Brigham & Women's Hospital (Boston, Massachusetts)."
Answered by AI
What goals are being sought through this scientific exploration?
"Per Spinal Kinetics, the study's primary outcome - Additional Surgical Intervention - will be observed over a two year timespan. Secondary outcomes such as Patient Satisfaction (measured on a five point scale), Health-Related Quality of Life assessed with the SF-12v2 survey and FOSS Dysphagia Scale (ranging from 0 to 4) are also being taken into consideration."
Answered by AI
Who else is applying?
What state do they live in?
New York
Other
California
Texas
How old are they?
18 - 65
65+
What site did they apply to?
Memorial Orthopaedic Surgical Group
Beverly Hills Spine Surgery
Metropolitan Neurosurgery Associates - Englewood Health
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
3+
Why did patients apply to this trial?
I'm in a seemingly endless downward spiral with less and less hope for my existence.
PatientReceived 1 prior treatment
I would like to contribute to research on cervical disk degeneration, if I am a suitable candidate.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
what are the exclusion criteria?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Average response time
- < 2 Days
Most responsive sites:
- Institute of Neuro Innovation: < 48 hours
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