Perform Humeral System Study
Eligible age
18+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation. Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.
Sponsor: Stryker Trauma and Extremities
You may qualify if…
- ✓ 18 years or older at the time of the informed consent or non-opposition (when applicable).
- ✓ Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).
- ✓ Willing and able to comply with the requirements of the study protocol.
- ✓ Considered a candidate for shoulder arthroplasty using a 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
- ✕ 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
Where it's recruiting
Lexington
Eagan · Rochester
St Louis
Sioux Falls
Salt Lake City
Source: ClinicalTrials.gov · NCT05067543 · last updated 2026-02-20