Evaluating the Zimmer Biomet Shoulder Replacement System

Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study

This study is testing how safe and effective the Zimmer Biomet Shoulder Replacement System is for people getting shoulder surgery, looking at their pain, movement, and quality of life over two years.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Zimmer Biomet (industry)
• Locations: 2 sites (Pforzheim and 1 other locations)
• Trial ID: NCT06920459 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective observational study aims to assess the safety and performance of the Zimmer Biomet Shoulder Arthroplasty systems in patients undergoing primary anatomic shoulder arthroplasty. The study will monitor adverse events and evaluate improvements in pain, functional performance, quality of life, and radiographic parameters over a two-year period. The primary endpoint focuses on the American Shoulder and Elbow Surgeons (ASES) shoulder score, while secondary endpoints will further assess safety and overall patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 20 and older who require shoulder arthroplasty due to conditions like osteoarthritis, rheumatoid arthritis, or shoulder fractures.

Not a fit: Patients who are unwilling or unable to provide consent or have conditions that may pose undue risk are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide evidence for the effectiveness and safety of the Zimmer Biomet Shoulder Arthroplasty systems, potentially improving treatment options for patients with shoulder conditions.

How similar studies have performed: Other studies evaluating shoulder arthroplasty systems have shown promising results, indicating that this approach is supported by prior successful research.

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.

Where this trial is running

Pforzheim and 1 other locations

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

Study contacts

• Study coordinator: Carina Hafner

Conditions: Shoulder Fractures, Shoulder Arthritis Osteoarthritis, Shoulder Injury, Shoulder Pain, Degenerative Joint Disease, Arthritis Shoulder, medical device, PMCF