Zimmer Biomet Shoulder Arthroplasty PMCF Study

Recruiting now

Conditions studied: Shoulder Fractures, Shoulder Arthritis Osteoarthritis, Shoulder Injury, Shoulder Pain, Degenerative Joint Disease, Arthritis Shoulder

In brief

This is a multicenter, prospective, non-controlled post market surveillance study. The objectives of this study are to confirm the safety, performance, and clinical benefits of the Zimmer Biomet Shoulder Arthroplasty systems in primary anatomic shoulder arthroplasty and its instrumentation. Safety of the systems will be assessed by monitoring the frequency and incidence of adverse events. The performance and clinical benefits will be evaluated by assessment of the overall pain and functional performance, qualify of life, and radiographic parameters of all enrolled study subjects.

Key facts

Study ID

NCT06920459

Run by

Zimmer Biomet

People needed

50

Starts

2025-04-29

Expected to finish

2037-06-01

Last updated by the study team

2026-06-08

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

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. 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.

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.
• 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.

Where it is running

• ARCUS Kliniken Pforzheim — Pforzheim, Germany (enrolling)
• Meander Medisch Centrum — Amersfoort, TZ, Netherlands (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.