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NCT04122248 · ClinicalTrials.gov registry record

M6-C Post Approval Study (PAS)

A clinical trial of Cervical Degenerative Disc Disease and Cervical Radiculopathy, sponsored by Spinal Kinetics.

Active
Registry status
152
Enrollment target
20
Study locations

NCT04122248 is a study of Cervical Degenerative Disc Disease and Cervical Radiculopathy that is active but no longer recruiting, run by Spinal Kinetics. The registered enrollment target is 152 participants, below the 256-participant average among 4 other Cervical Degenerative Disc Disease trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT04122248, a study of Cervical Degenerative Disc Disease and Cervical Radiculopathy, is active but no longer recruiting, sponsored by Spinal Kinetics.

ACTIVE NOT RECRUITING
Registry status
152 participants
Enrollment target
20
Study locations

Study Summary

The M6-C Post Approval Study is a long term follow-up study of subjects previously enrolled and treated in the M6-C Artificial Cervical Disc IDE Study.

Conditions Studied

Cervical Degenerative Disc Disease Cervical Radiculopathy Cervical Disc Herniation Cervical Spinal Cord Compression

Interventions

  • OTHER standard radiographic imaging
  • DEVICE cervical total disc replacement

Study Locations (20)

California

  • Spine MD - Beverly Hills
  • Memorial Orthopedic Surgical Group - Long Beach
  • Stanford University - Stanford

North Carolina

  • CNSA - Charlotte
  • OrthoCarolina Research Institute - Charlotte
  • EmergeOrtho - Durham

Arizona

  • Desert Institute for Spine Care - Phoenix
  • The CORE Institute - Sun City West

Colorado

  • University of Colorado School of Medicine - Aurora
  • ClinTech Center for Spine - Johnstown

New York

  • HSS - New York
  • Upstate Medical University - Syracuse

Connecticut

  • Yale University School of Medicine - New Haven

District of Columbia

  • Medstar Hospital/Georgetown University - Washington D.C.

Illinois

  • Midwest Orthopedics - Chicago

Trial Details

FieldValue
Enrollment Target 152 participants
Start Date 2019-11-30
Est. Completion 2026-06-30

Sponsor

Spinal Kinetics

1 total trials

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What the Registry Record Tells You About NCT04122248

The ClinicalTrials.gov registry entry for NCT04122248 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 256-participant average among 4 other Cervical Degenerative Disc Disease trials with a reported enrollment target (41% lower). The listed sponsor is Spinal Kinetics, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Cervical Degenerative Disc Disease appearing as the primary indexed condition, and to 2 interventions - of which standard radiographic imaging is the first listed.

NCT04122248 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, North Carolina, Arizona.

Frequently Asked Questions

What is clinical trial NCT04122248 about?

NCT04122248 is a clinical study titled "M6-C Post Approval Study (PAS)". The M6-C Post Approval Study is a long term follow-up study of subjects previously enrolled and treated in the M6-C Artificial Cervical Disc IDE Study.

What is the current status of trial NCT04122248?

This trial is currently active not recruiting. The enrollment target is 152 participants. The study started on 2019-11-30. Estimated completion is 2026-06-30.

What conditions does trial NCT04122248 study?

This clinical trial studies the following conditions: Cervical Degenerative Disc Disease, Cervical Radiculopathy, Cervical Disc Herniation, Cervical Spinal Cord Compression.

What interventions are being tested in trial NCT04122248?

The interventions under investigation include: standard radiographic imaging (OTHER), cervical total disc replacement (DEVICE).

Who is sponsoring clinical trial NCT04122248?

This trial is sponsored by Spinal Kinetics, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04122248 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.