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NCT04982835 · ClinicalTrials.gov registry record · NA
M6-C Artificial Cervical Disc Two-Level IDE Pivotal Study
A NA study of Cervical Disc Degenerative Disorder, sponsored by Orthofix.
- Active
- Registry status
- NA
- Development phase
- 156
- Enrollment target
- 20
- Study locations
NCT04982835: Active NA study of Cervical Disc Degenerative Disorder, sponsored by Orthofix.
NCT04982835 is a NA study of Cervical Disc Degenerative Disorder that is active but no longer recruiting, run by Orthofix. The registered enrollment target is 156 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04982835, a NA study of Cervical Disc Degenerative Disorder, is active but no longer recruiting, sponsored by Orthofix.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 156 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Change in condition-specific functional impairment will be evaluated using a 10 item NDI outcomes questionnaire to assess change in the functional impairment score. NDI scores range from 0-50 (0%-100%) with higher scores demonstrating greater disability.
Conditions Studied
Interventions
- DEVICE M6-C Artificial Cervical Disc
- DEVICE ACDF
Study Locations (20)
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
Arizona
- Desert Institute for Spine Care - Phoenix
Georgia
- Longstreet Clinic - Gainesville
Idaho
- Axis Spine - Coeur d'Alene
Illinois
- Carle Health - Urbana
Massachusetts
- Brigham & Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2021-07-26 |
| Est. Completion | 2026-12 |
| Phase | NA |
What the registry record for NCT04982835 still lists
NCT04982835 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Cervical Disc Degenerative Disorder appearing as the primary indexed condition, and to 2 interventions - of which M6-C Artificial Cervical Disc is the first listed.
NCT04982835 names 20 study sites across 13 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT04982835 about?
NCT04982835 is a clinical study titled "M6-C Artificial Cervical Disc Two-Level IDE Pivotal Study". 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...
What is the current status of trial NCT04982835?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 156 participants. The study started on 2021-07-26. Estimated completion is 2026-12.
What conditions does trial NCT04982835 study?
This clinical trial studies the following conditions: Cervical Disc Degenerative Disorder.
What interventions are being tested in trial NCT04982835?
The interventions under investigation include: M6-C Artificial Cervical Disc (DEVICE), ACDF (DEVICE).
Who is sponsoring clinical trial NCT04982835?
This trial is sponsored by Orthofix, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04982835 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04982835's enrollment target sits among peer trials
156 656th of 2000 higher than 1,345 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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