Tornier HRS (Humeral Reconstruction System) Study (REVIVE)

Official 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.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 110 participants

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.

Primary Outcomes

• Average Improvement from Baseline to last follow-up visit in ASES Score (24 Month)

Secondary Outcomes

• Constant Score (through study completion, an average of 1 year)
• SANE (through study completion, an average of 1 year)
• EQ 5-D (through study completion, an average of 1 year)
• Patient Satisfaction (through study completion, an average of 1 year)
• Radiographic Findings (Baseline, 1 year, 2 year, 5 year and 10 year)

Trial Locations

• 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

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