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Enrolling by invitationNo phase

Follows people receiving the Tornier HRS shoulder device for shoulder conditions

Observes how a shoulder replacement system performs in adults with shoulder arthritis or fractures.

Key facts

Who runs it
Stryker Trauma and Extremities
Where
Bradenton, Denver, Lexington, and Tampa, United StatesSee the 4 sites
Trial code
Registry title
Tornier HRS (Humeral Reconstruction System) Study (REVIVE)
Status
Enrolling by invitation
People taking part
110 people, planned
Started
11 Jan 2023
Expected to end
3 Jan 2036
Type of study
Observational
Treatments tested
  • Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system
Record updated
30 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who are candidates for shoulder replacement surgery with the Tornier HRS shoulder system, for conditions such as arthritis, humerus fracture or rotator cuff tears.

Age
18 years or older
Sex
All sexes can join
Disease stage
Shoulder problems such as rheumatoid arthritis, osteoarthritis, humerus fractures, avascular necrosis, traumatic arthritis or rotator cuff tears, where shoulder replacement with the study device is being considered.

Main reasons for not taking part

  • Active infection, sepsis or osteomyelitis
  • Poor bone quality or too little bone in the upper arm bone or shoulder socket
  • Significant injury to the brachial plexus
  • Neuromuscular disease
  • Pregnancy

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • 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
  • 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

Where in United States

  • Coastal OrthopedicsBradenton, United StatesEnrolling by invitation
  • HCA Healthcare Research InstituteDenver, United StatesEnrolling by invitation
  • Baptist Health LexingtonLexington, United StatesEnrolling by invitation
  • Foundation for Orthopaedic Research & EducationTampa, United StatesEnrolling by invitation

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system

    Commercially available shoulder system available in both anatomic and reversed configurations.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Tornier HRS (Humeral Reconstruction System) Study (REVIVE)
Plain-language title
Follows people receiving the Tornier HRS shoulder device for shoulder conditionsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
30 March 2026