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ACTIVE NOT RECRUITING NA

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

NCT04982835 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 156 participants
Start Date 2021-07-26
Est. Completion 2026-12
Phase NA

Sponsor

Orthofix

6 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04982835 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04982835?

The interventions under investigation include: M6-C Artificial Cervical Disc (DEVICE), ACDF (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04982835?

This trial is sponsored by Orthofix, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial