Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 20 study locations across 13 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04982835
The ClinicalTrials.gov registry entry for NCT04982835 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 156 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Orthofix, which has 14 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.