Tornier HRS (Humeral Reconstruction System) Study (REVIVE)

Enrolling by invitation

Conditions studied: 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

In brief

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 facts

Study ID

NCT05500066

Run by

Stryker Trauma and Extremities

People needed

110

Starts

2023-01-11

Expected to finish

2036-01-03

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years or older at the time of the informed consent.
• Informed and willing to sign an informed consent form approved by IRB or Ethics Committee (EC) (when applicable).
• Willing and able to comply with the requirements of the study protocol.
• Considered for a candidate for shoulder arthroplasty using the study device
• Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements

You may not qualify if…

• Not able to comply with the study procedures based on the judgment of the assessor (e.g., cannot comprehend study questions, inability to keep scheduled assessment times)
• Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm).
• Active local or systemic infection, sepsis, or osteomyelitis
• Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid (reassessed at time of surgery)
• Significant injury to the brachial plexus
• Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
• Neuromuscular disease (e.g., joint neuropathy)
• Patient with known allergy to one of the product materials
• Metabolic disorders which may impair bone formation
• Patient pregnancy
• Planned for two-stage surgery (reassessed at time of surgery)

Where it is running

• 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

Full record on ClinicalTrials.gov

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