Perform Humeral System Study

Launched by STRYKER TRAUMA AND EXTREMITIES · Oct 4, 2021

Keywords

ClinConnect Summary

The Perform Humeral System Study is a clinical trial aimed at evaluating the safety and effectiveness of a new device for shoulder surgery in patients with conditions like osteoarthritis, rotator cuff tears, and other shoulder issues. This study is open to adults aged 18 and older who are considering shoulder joint replacement surgery using the study device. Participants will need to provide informed consent, meaning they understand the study and agree to take part. However, certain individuals may not be eligible, such as those with infections, poor bone quality, or those who cannot follow the study's procedures.

If you choose to participate, you can expect to be followed for up to 10 years after your surgery. Researchers will collect information at various points, including before the surgery, immediately after, and then annually, to understand how the device performs and ensure it is safe for patients. This study will help improve patient care and may contribute to future medical research and education.

Gender

ALL

Eligibility criteria

• 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