M6-C Artificial Cervical Disc for Cervical Disc Degeneration

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cervical Disc DegenerationM6-C Artificial Cervical Disc - Device
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Cervical Disc Degeneration

Treatment Effectiveness

Study Objectives

5 Primary · 7 Secondary · Reporting Duration: 24 Month

24 Month
Operative Surgical Procedures
- Neurologic Function
- Serious Adverse Event(s)
FOSS Dysphagia Scale
Neck
Health-Related Quality of Life
Neck and Arm Pain
Odom's Criteria
Overall Participant Success Rate (M6-C Artificial Cervical Disc)
Patient Satisfaction
Radiographic Assessments
24 Months
Pain Medication Usage

Trial Safety

Trial Design

3 Treatment Groups

Anterior Cervical Discectomy & Fusion (ACDF)
1 of 3
Ant. Cervical Discectomy & Fusion (ACDF)
1 of 3
M6-C Artificial Cervical Disc
1 of 3

Active Control

Experimental Treatment

263 Total Participants · 3 Treatment Groups

Primary Treatment: M6-C Artificial Cervical Disc · No Placebo Group · N/A

M6-C Artificial Cervical Disc
Device
Experimental Group · 1 Intervention: M6-C Artificial Cervical Disc · Intervention Types: Device
Anterior Cervical Discectomy & Fusion (ACDF)
Device
ActiveComparator Group · 1 Intervention: ACDF · Intervention Types: Device
Ant. Cervical Discectomy & Fusion (ACDF)
Device
ActiveComparator Group · 1 Intervention: ACDF · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 month

Who is running the clinical trial?

Spinal KineticsLead Sponsor
2 Previous Clinical Trials
466 Total Patients Enrolled
Frank Phillips, MDPrincipal InvestigatorRush University Medical Center

Eligibility Criteria

Age 18 - 75 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have 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.
You are 18 or older and you are skeletally mature.
You have progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management.
The Neck Disability Index score is 30% or higher.
Neck or arm pain is present.
You are willing and able to comply with the requirements of the protocol including follow-up requirements.

Who else is applying?

What state do they live in?
California50.0%
New York50.0%
How old are they?
65+50.0%
18 - 6550.0%
What site did they apply to?
Memorial Orthopaedic Surgical Group50.0%
Upstate Medical University50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%