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Perform® Humeral System - Fracture Study (PFX)

Study acronym: PFX
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 1, 2026 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Re-verified, no change to tracked fieldsv11
  2. Primary completion moved earlier from Sep 1, 2028 to Oct 1, 2026 Completion pushed from Sep 1, 2033 to Sep 1, 2034 · Enrollment target: 125 to 118v10 Show 2 more changesShow less
    • Completion pushed from Sep 1, 2033 to Sep 1, 2034
    • Enrollment target: 125 to 118
  3. Re-verified, no change to tracked fieldsv9
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 120 to confirmed 125 · Study sites: 7 to 9 · Study description expanded, about 2 wordsv8 Show 3 more changesShow less
    • Enrollment target: estimated 120 to confirmed 125
    • Study sites: 7 to 9
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 5 to 7v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 3 to 5v6
  2. Study sites: 2 to 3v5
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Aug 28, 2023 to Aug 31, 2023v4 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Aug 28, 2023 to Aug 31, 2023
  4. Start date: Jun 1, 2023 to Aug 28, 2023 Primary completion date: Jun 1, 2028 to Sep 1, 2028 · Completion date: Jun 1, 2033 to Sep 1, 2033v3 Show 2 more changesShow less
    • Primary completion date: Jun 1, 2028 to Sep 1, 2028
    • Completion date: Jun 1, 2033 to Sep 1, 2033
  5. Secondary endpoints: 5 to 6v2 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF), which is designed to collect safety and performance data on commercially available Perform® Fracture. Data collected from this study will be used for purposes, including but not limited to, PMS, peer-reviewed publications, education materials, future regulatory submissions, and/or product development.
Trial Details
NCT Number NCT05773352
Lead Sponsor Stryker Trauma and Extremities
Conditions Traumatic Arthropathy of Shoulder, Fracture Humerus, Traumatic Arthritis, Revision of Other Devices if Sufficient Bone Stock Remains
Enrollment 118 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov