Tornier HRS (Humeral Reconstruction System) Study (REVIVE)

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.

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	2023-01-11
Primary Completion	2028-01-06 (estimated)
Study Completion	2036-01-03 (estimated)
Updated on ClinicalTrials.gov	2026-03-30