Zimmer Biomet Shoulder Arthroplasty PMCF Study

Launched by ZIMMER BIOMET · Apr 2, 2025

Keywords

ClinConnect Summary

The Zimmer Biomet Shoulder Arthroplasty PMCF Study is a clinical trial designed to evaluate the safety and effectiveness of a specific shoulder replacement system for patients with shoulder problems, such as fractures, arthritis, or degenerative joint disease. The study aims to understand how well this shoulder system works in relieving pain and improving patients' quality of life after surgery. Researchers will keep track of any side effects and assess how patients feel and function over time.

To participate in this study, you must be at least 20 years old and have a shoulder condition that makes you a good candidate for shoulder replacement surgery. This could include conditions like arthritis or previous shoulder fractures that haven’t responded well to other treatments. Participants will need to agree to follow up after their surgery and sign an informed consent form, which means they understand what the study involves. It's important to note that certain individuals, such as those who are pregnant or have significant health issues affecting their ability to follow the study's requirements, may not be eligible. If you join the study, you can expect regular check-ins to monitor your progress and help researchers gather important information about the shoulder replacement system.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient must be 20 years of age or older.
• • Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants.
• * Patient is a candidate for shoulder arthroplasty due to one or more of the following:
• • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• • Rheumatoid arthritis. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• • Difficult clinical management problems, where other method of treatment may not be suitable or may be inadequate.
• • Patient must be able and willing to complete the protocol required follow-up.
• • Patient must be able and willing to sign the IRB/EC approved informed consent.
• Exclusion Criteria:
• • Patient is unwilling or unable to give consent or to comply with the follow-up program.
• • Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study.
• • Patient is known to be pregnant or breastfeeding.
• • Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non- compliant).
• • Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.
• • Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site.
• • Patient has rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram.
• • Patient has any neuromuscular disease compromising the affected limb that would render the procedure unjustifiable.
• • Patient presents with osteoporosis, which in the opinion of the Investigator, may limit the subject's ability to support total shoulder arthroplasty using the study device.
• • Patient has a metabolic disorder that may impair bone formation.
• • Patient has osteomalacia.