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Pyrocarbon Clinical Follow-up Study

Study acronym: PYC CFS
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv8
  2. Study sites revised (8)v7 See this version in full on ClinicalTrials.gov ↗
  3. Trial status: Enrolling by Invitation to Active, Not Recruiting Enrollment target: estimated 100 to confirmed 76v6 Show 1 more changeShow less
    • Enrollment target: estimated 100 to confirmed 76
  4. Study sites: 7 to 8v5
  5. Study sites: 1 to 7v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Enrolling by Invitation Start date changed from estimate of Sep 13, 2021 to Oct 27, 2021 · Site contact updatedv3 Show 2 more changesShow less
    • Start date changed from estimate of Sep 13, 2021 to Oct 27, 2021
    • Site contact updated
  2. Lead sponsor: [Redacted] to Stryker Trauma and Extremities Trial status: Withheld to Not Yet Recruiting · Primary completion date: May 31, 2027 · Completion date: Dec 31, 2027 · 2 morev2 Show 5 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary completion date: May 31, 2027
    • Completion date: Dec 31, 2027
    • Start date: Sep 13, 2021
    • Study title shortened, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The objective of this multi-center study is to collect medium and long-term data on the related clinical complications and functional outcomes of the Pyrocarbon Humeral Head to demonstrate safety and performance, in subjects from the Pyrocarbon IDE Study cohort. Data collected from this study will support post-market surveillance and MDR requirements as well provide the basis for peer-reviewed publications on mid- and long-term product performance and safety (five to ten years post-op).
Trial Details
NCT Number NCT05049993
Lead Sponsor Stryker Trauma and Extremities
Conditions Osteoarthritis of the Shoulder, Avascular Necrosis, Traumatic Arthritis
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov