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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: Active study of Cervical Degenerative Disc Disease and Cervical Radiculopathy, sponsored by Spinal Kinetics.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

A study subject will be considered an overall success if he/she meets the following criteria: * No serious adverse event(s) classified as device or device procedure related (as determined by the CEC), and * No subsequent surgical procedure at the index level (including revision, removal, reoperation, or supplemental fixation), and * Maintenance or improvement in neurological function, and * Improvement on the NDI of at least 15 points.

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
Spinal Kinetics

1 total trials

What the registry record for NCT04122248 still lists

NCT04122248 is an observational study that tracks outcomes without assigning an intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 256-participant average among 4 other Cervical Degenerative Disc Disease trials with a reported enrollment target (41% lower).

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 names 20 study sites across 13 states, led by 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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Related registry views

Source: ClinicalTrials.gov NCT04122248, the US trial registry maintained by the National Library of Medicine. NCT04122248 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.