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Tornier HRS (Humeral Reconstruction System) Study (REVIVE)

Study acronym: REVIVE
StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study Identification, Study Statusv7
  2. Interventions: Aequalis Flex Revive Shoulder System (Device) to Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system (Device) Study description expanded, about 41 words · Study sites revised (4) · Study title expanded, about 2 wordsv6 Show 3 more changesShow less
    • Study description expanded, about 41 words
    • Study sites revised (4)
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv5
  4. Study sites: 3 to 4v4
  5. Study sites: 1 to 3v3
  6. Trial status: Not Yet Recruiting to Enrolling by Invitation Start date: Dec 2, 2022 to Jan 11, 2023 · Study sites: 0 to 1v2 Show 2 more changesShow less
    • Start date: Dec 2, 2022 to Jan 11, 2023
    • Study sites: 0 to 1
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study. Data will be collected for the commercially available Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system in both the anatomic and reversed configurations. Retrospective inclusions are allowed: study patients may be enrolled up to 3 months after date of surgery provided that the necessary pre-operative (baseline) and surgery data are accessible. Follow-up visits conducted from 3-month post-surgery onward must be prospective. The purpose of this study is to collect data needed to satisfy the European Union (EU) Medical Device Regulation (MDR) clinical post-market surveillance (PMS) and reporting requirements, and to support future regulatory submissions and peer-reviewed publications on device performance and safety.
Trial Details
NCT Number NCT05500066
Lead Sponsor Stryker Trauma and Extremities
Conditions Rheumatoid Arthritis, Osteoarthritis Shoulder, Fractures Humerus, Avascular Necrosis, Correction of Functional Deformity, Traumatic Arthritis, Revision of Other Devices if Sufficient Bone Stock Remains, Rotator Cuff Tears
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov