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NCT05500066

Tornier HRS (Humeral Reconstruction System) Study (REVIVE)

Sponsor: Stryker Trauma and Extremities

View on ClinicalTrials.gov

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

Interventions

DEVICE

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