RecruitingShoulder FracturesShoulder ArthritisShoulder Osteoarthritis

Zimmer Biomet Shoulder Arthroplasty PMCF

Eligible age

20+ yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

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About this study

The objectives of this study are to confirm the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation in primary or revision shoulder arthroplasty. These objectives will be assessed using standard scoring systems, radiographic evidence, and adverse event records. Safety of the system will be assessed by monitoring the frequency an incidence of adverse events.

Sponsor: Zimmer Biomet

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.