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Perform Humeral System Study

Study acronym: PHS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jun 30, 2036 → Jun 30, 2037
See other at-risk trials from Stryker Trauma and Extremities

Record History

  1. Re-verified, no change to tracked fieldsv11
  2. Primary completion pushed from Jun 30, 2036 to Jun 30, 2037 Completion pushed from Dec 1, 2036 to Dec 1, 2037 · Study sites: 10 to 11v10 Show 2 more changesShow less
    • Completion pushed from Dec 1, 2036 to Dec 1, 2037
    • Study sites: 10 to 11
  3. Primary completion date: Jun 30, 2035 to Jun 30, 2036 Completion date: Dec 1, 2035 to Dec 1, 2036 · Site details revised at 7 of 10 sitesv9 Show 2 more changesShow less
    • Completion date: Dec 1, 2035 to Dec 1, 2036
    • Site details revised at 7 of 10 sites
  4. Study sites: 9 to 10v8
  5. Enrollment target: 200 to 300 Primary completion date: Jun 30, 2033 to Jun 30, 2035 · Trial status: Enrolling by Invitation to Recruiting · Study sites: 7 to 9 · 2 morev7 Show 5 more changesShow less
    • Primary completion date: Jun 30, 2033 to Jun 30, 2035
    • Trial status: Enrolling by Invitation to Recruiting
    • Study sites: 7 to 9
    • Completion date: Dec 1, 2033 to Dec 1, 2035
    • Study description expanded, about 88 words

    See this version in full on ClinicalTrials.gov ↗

Show 5 earlier versionsHide 5 earlier versions
  1. 2 versions Re-verified since Mar 24, 2023, no change to tracked fieldsv5-v6
  2. Study sites: 5 to 7v4
  3. Study sites: 2 to 5v3
  4. Study sites: 1 to 2v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation. Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.
Trial Details
NCT Number NCT05067543
Lead Sponsor Stryker Trauma and Extremities
Conditions Osteoarthritis Shoulder, Avascular Necrosis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Rotator Cuff Tear Arthropathy
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov