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ACDF Using Structural Allograft vs. Tritanium C

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv10
  2. Site contact updatedv9
  3. Phase: Not specified to Not applicablev8 Show 4 more changesShow less
    • Enrollment target: 40 to 60
    • Eligibility criteria expanded, about 47 words
    • Study description expanded, about 43 words
    • Site contact updated
  4. Primary completion date: Dec 2022 to Dec 2026
    • Study completion date: Dec 2023 to Dec 2026
    v7
  5. Primary completion date: Jul 2022 to Dec 2022
    • Study completion date: Aug 2022 to Dec 2023
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Jul 2021 to Jul 2022
    • Study completion date: Aug 2021 to Aug 2022
    • Site contact updated
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2020 to Aug 20, 2020
    • Site details revised
    v4
  3. Start date: Jul 2020 to Aug 2020v3
  4. Start date: May 2020 to Jul 2020
    • Primary completion date: Jun 2021 to Jul 2021
    • Study completion date: Sep 2021 to Aug 2021
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 an observational, descriptive, prospective and retrospective data collection study. The purpose of this study is to observe radiographic outcomes of patients who will undergo anterior cervical discectomy and fusion (ACDF) utilizing Tritanium C (Stryker Spine). The rate of fusion success and adverse events will be compared retrospectively to patients who underwent instrumented ACDF utilizing structural allograft bone with plates.
Trial Details
NCT Number NCT04388332
Lead Sponsor Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators: VB Spine, LLC
Conditions
(from sponsor)		 Degenerative Disc Disease
Related terms Intervertebral Disc Degeneration
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov