NCT05500066Enrolling by invitation
Tornier HRS (Humeral Reconstruction System) Study (REVIVE)
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 110 (estimated)
- First submitted
- 4 Aug 2022
- Start date
- 11 Jan 2023
- Primary completion date
- 6 Jan 2028
- Lead sponsor
- Stryker Trauma and Extremities
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05500066
What you commit to
- Study type: Observational
- Planned participants: 110
- From 11 Jan 2023 to the primary completion date, 6 Jan 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Planned for two-stage surgery (reassessed at time of surgery)
Other illness
- Active local or systemic infection, sepsis, or osteomyelitis
- Neuromuscular disease (e.g., joint neuropathy)
- Patient with known allergy to one of the product materials
- Metabolic disorders which may impair bone formation
Other
- 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).
- Significant injury to the brachial plexus
- Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
- Patient pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Coastal Orthopedics Coordinator of this site? Confirm its status | Bradenton | United States | Unknown status |
| HCA Healthcare Research Institute Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Baptist Health Lexington Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Foundation for Orthopaedic Research & Education Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.