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Tornier HRS (Humeral Reconstruction System) Study (REVIVE)
Sponsor: Stryker Trauma and Extremities
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
110
Start Date
2023-01-11
Completion Date
2036-01-03
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system
Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system is intended for use as: * A replacement of shoulder joints in primary anatomic or in primary reverse * A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains. The system also allows for conversion from anatomic to reverse shoulder prosthesis in case of revision.
Locations (4)
HCA Healthcare Research Institute
Denver, Colorado, United States
Coastal Orthopedics
Bradenton, Florida, United States
Foundation for Orthopaedic Research & Education
Tampa, Florida, United States
Baptist Health Lexington
Lexington, Kentucky, United States