Evaluation of the PERFORM™ Humeral System for shoulder conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international, multicenter observational study aims to collect safety and performance data on the PERFORM™ Humeral System after shoulder arthroplasty. Participants will be monitored at baseline, immediately post-operation, and annually for up to 10 years. The study will utilize Patient Reported Outcome Measures to assess quality of life, pain, functional improvements, and safety of the implants, alongside radiographic evaluations. The data gathered will support post-market surveillance and contribute to regulatory submissions and educational materials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Metabolic disorders which may impair bone formation
* Patient pregnancy
* Planned for two-stage surgery

Where it's running

• Baptist Healthcare
  Lexington, Kentucky, United States Recruiting
• Summit Orthopedics
  Eagan, Minnesota, United States Recruiting
• Ohio State University
  Columbus, Ohio, United States Recruiting
• Orthopedic Institute
  Sioux Falls, South Dakota, United States Recruiting
• University of Utah
  Salt Lake City, Utah, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Terminated

Study contacts

• Study coordinator: Amjad Uneisi
• Email: amjad.uneisi@stryker.com
• Phone: 33638213703

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.