Clinical Trial

M6-C Artificial Cervical Disc Two-Level IDE Pivotal Study

Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated November 14, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 16 amendments
This ClinicalTrials.gov record has been amended 16 times since 2021-07-23; most recent amendment 2025-11-12.
Status change: Recruiting → Active, Not Recruiting 2025-07-25
Status change: Withdrawn → Recruiting 2021-08-05
Trial Details
NCT Number NCT04982835
Lead Sponsor Orthofix Inc.
Collaborators: Spinal Kinetics
Conditions Cervical Disc Degenerative Disorder
Enrollment 156 participants
Start Date 2021-07-26
Primary Completion 2025-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-11-14