Zimmer Biomet Shoulder Arthroplasty PMCF

Launched by ZIMMER BIOMET · Jul 29, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of Zimmer Biomet Shoulder Arthroplasty Systems, which are devices used to replace or repair damaged shoulders. The goal is to see how well these systems work for patients with various shoulder problems, such as arthritis, fractures, or serious shoulder injuries. Researchers will track the health and recovery of participants using standard scoring methods and will also keep an eye on any side effects that may occur during the study.

To join this trial, participants need to be at least 20 years old and have specific shoulder issues that make them suitable for this type of surgery. This includes conditions like severe arthritis or fractures that haven’t responded to other treatments. Participants should be able to follow the study guidelines and will need to sign a consent form agreeing to take part. Throughout the trial, participants can expect regular check-ins with the research team to monitor their progress and any potential side effects from the shoulder replacement system. It’s important to note that certain health conditions, like infections or severe bone loss, may prevent someone from participating.

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.
• • Correction of functional deformity.
• • Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• • Difficult clinical management problems, where other methods 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.
• • Patient has grossly deficient rotator, (for reverse application)
• • With severe arthropathy and/or
• • Previously failed shoulder joint replacement
• • Patient must have functional deltoid muscle (for reverse application)
• 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 osteomalacia.
• • Patient has a metabolic disorder that may impair bone formation.
• • Patient has deficient rotator cuff.
• • Patient presents with significant injury to the upper brachial plexus.
• • Patient has paralysis of the axillary nerve.
• • Patient has non-functional deltoid or external rotator muscles.