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NCT05500066

Tornier HRS (Humeral Reconstruction System) Study (REVIVE)

Enrolling by Invitation
Not specifiedAges 18+Observational
Stryker 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

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

Explore related trials

Avascular NecrosisHumerus FractureOsteoarthritis of glenohumeral jointRheumatoid ArthritisRupture of rotator cuff of shoulderTraumatic Arthritis

NCT05500066

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baptist Health Lexington

    Lexington, Kentuckyno site contact published

  • Coastal Orthopedics

    Bradenton, Floridano site contact published

  • Foundation for Orthopaedic Research & Education

    Tampa, Floridano site contact published

  • HCA Healthcare Research Institute

    Denver, Coloradono site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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

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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