NCT05500066
Tornier HRS (Humeral Reconstruction System) Study (REVIVE)
Enrolling by Invitation
Not specifiedAges 18+ObservationalStryker Trauma and Extremities
~110 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system
At a glance
Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Average Improvement from Baseline to last follow-up visit in ASES Score
Measured over 24 Month
Conditions
Where it's being run
4 sites across 3 statesFlorida2
Colorado1
Kentucky1
Study leadership
- Rebecca Gibson · STUDY_DIRECTOR · Stryker Trauma and Extremities
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Exclusion
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)
What this trial measures
- Average Improvement from Baseline to last follow-up visit in ASES Score24 Month
ASES Score = American Shoulder and Elbow Surgeons Score, 11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function