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Active, not recruiting Not applicable Interventional

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

ClinicalTrials.gov ID: NCT04982835

Public ClinicalTrials.gov record NCT04982835. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 12:51 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04982835
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Orthofix Inc.
Industry
Enrollment
156 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 26, 2021 (Actual)
Primary completion
Dec 2025 (Estimated)
Completion
Dec 2026 (Estimated)
Last update posted
Nov 14, 2025

2021 – 2026

United States locations

U.S. sites
21
U.S. states
13
U.S. cities
21
Facility City State ZIP Site status
Desert Institute for Spine Care Phoenix Arizona 85020 —
Beverly Hills Spine Surgery Beverly Hills California 90210 —
Memorial Orthopaedic Surgical Group Long Beach California 90806 —
Disc Sports & Spine Center Newport Beach California 92660 —
UC Irvine Medical Center Orange California 92868 —
Institute of Neuro Innovation Santa Monica California 90404 —
St. Charles Spine Institute Thousand Oaks California 91860 —
University of Colorado School of Medicine - Department of Orthopedics Aurora Colorado 80045 —
Steadman Philipon Research Institute Vail Colorado 81657 —
Orlando Health Orlando Florida 32809 —
Joseph Spine Institute Tampa Florida 33607 —
Longstreet Clinic Gainesville Georgia 30801 —
Axis Spine Coeur d'Alene Idaho 83815 —
Carle Health Urbana Illinois 61801 —
Brigham & Women's Hospital Boston Massachusetts 02115 —
Michigan Orthopedic Surgeons Southfield Michigan 48033 —
The Orthopedic Center of St. Louis St Louis Missouri 63017 —
Metropolitan Neurosurgery Associates - Englewood Health Englewood New Jersey 07631 —
Mayfield Clinic Cincinnati Ohio 45209 —
St. David's Healthcare Austin Texas 78705 —
American Neurospine Institute/Medical City Frisco Frisco Texas 75033 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04982835, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 14, 2025 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04982835 live on ClinicalTrials.gov.

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