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NCT04214535 · ClinicalTrials.gov registry record · NA

Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels

A NA study of Degenerative Disc Disease and Cervical Disc Herniation, sponsored by Corewell Health East.

Active
Registry status
NA
Development phase
50
Enrollment target
1
Study location

NCT04214535: Active NA study of Degenerative Disc Disease and Cervical Disc Herniation, sponsored by Corewell Health East.

NCT04214535 is a NA study of Degenerative Disc Disease and Cervical Disc Herniation that is active but no longer recruiting, run by Corewell Health East. The registered enrollment target is 50 participants, below the 168-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04214535, a NA study of Degenerative Disc Disease and Cervical Disc Herniation, is active but no longer recruiting, sponsored by Corewell Health East.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
50 participants
Enrollment target
1
Study location

Study Summary

This is a prospective, single arm clinical study to evaluate fusion status and patient reported outcomes utilizing the Stryker Tritanium® C Anterior Cervical interbody device at one or two contiguous levels. Subjects that are recommended for surgical treatment of either a 1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) between the levels of Cervical Spine 2 to Thoracic 1 (C2-T1) and diagnosed with degenerative disc disease will be screened for the study.

Primary Outcome

Count of participants with successful cervical fusion as measured by CT scan of the cervical spine and flexion and extension view x-rays at 12-months postoperative as evidenced by the following three criteria: bony bridging, no presence of radiolucency, and no development of pseudoarthrosis at the treated cervical level(s).

Interventions

  • DEVICE Tritanium C Anterior Cervical Cage

Study Locations (1)

Michigan

  • Corewell Health William Beaumont University Hospital - Royal Oak

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2021-05-05
Est. Completion 2027-03-30
Phase NA
Corewell Health East

106 total trials

What the registry record for NCT04214535 still lists

NCT04214535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 168-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (70% lower).

The record links to 3 conditions, with Degenerative Disc Disease appearing as the primary indexed condition, and to 1 intervention - of which Tritanium C Anterior Cervical Cage is the first listed.

NCT04214535 reports a single indexed study location in Michigan.

Frequently Asked Questions

What is clinical trial NCT04214535 about?

NCT04214535 is a clinical study titled "Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels". This is a prospective, single arm clinical study to evaluate fusion status and patient reported outcomes utilizing the Stryker Tritanium® C Anterior Cervical interbody device at one or two contiguous levels. Subjects that are recommended for surgical treatment of either a 1- or 2-level ACDF (Anterio...

What is the current status of trial NCT04214535?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2021-05-05. Estimated completion is 2027-03-30.

What conditions does trial NCT04214535 study?

This clinical trial studies the following conditions: Degenerative Disc Disease, Cervical Disc Herniation, Cervical Disc Degeneration.

What interventions are being tested in trial NCT04214535?

The interventions under investigation include: Tritanium C Anterior Cervical Cage (DEVICE).

Who is sponsoring clinical trial NCT04214535?

This trial is sponsored by Corewell Health East, which has 106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04214535 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Degenerative Disc Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04214535's enrollment target sits among peer trials

50 30th of 42 higher than 13 of 42 other Degenerative Disc Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Degenerative Disc Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04214535, the US trial registry maintained by the National Library of Medicine. NCT04214535 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.