Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04214535 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: Stryker Spine
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Mar 30, 2026 → Mar 30, 2027
See other at-risk trials from Corewell Health East

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Mar 30, 2026 to Mar 30, 2027
    • Study completion pushed from Mar 30, 2027 to Mar 30, 2028
    • Eligibility criteria expanded, about 7 words
    • Publications: details revised at 13 of 13 entries
  2. Re-verified, no change to tracked fieldsv12
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Dec 30, 2026 to Mar 30, 2026
    • Study completion date: Dec 30, 2026 to Mar 30, 2027
    • Site details revised
    v11
  4. Primary and study completion dates: Dec 30, 2024 to Dec 30, 2026
    • Site contact updated
    v10
  5. Study site revisedv9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary and study completion dates: Dec 30, 2023 to Dec 30, 2024
    • Secondary endpoints: details revised at 7 of 7 entries
    • Study description expanded, about 2 words
    v8
  2. Primary completion date: May 30, 2022 to Dec 30, 2023
    • Study completion date: May 30, 2023 to Dec 30, 2023
    v7
  3. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Primary completion date: Dec 1, 2021 to May 30, 2022
    • Study completion date: Dec 1, 2022 to May 30, 2023
    • Start date changed from estimate of Jun 2021 to May 5, 2021
    • Site details revised
  4. Start date: Sep 2020 to Jun 2021v5
  5. Start date: Jun 2020 to Sep 2020v4
  6. Start date: Feb 2020 to Jun 2020v3
  7. Secondary endpoints: details revised at 1 of 7 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04214535
Lead Sponsor Corewell Health East
Collaborators: VB Spine, LLC
Conditions
(from sponsor)		 Cervical Disc Herniation, Cervical Disc Degeneration, Degenerative Disc Disease
Related terms Intervertebral Disc Degeneration, Klippel-Feil Syndrome
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov