Actively Recruiting
Zimmer Biomet Shoulder Arthroplasty PMCF Study
Led by Zimmer Biomet · Updated on 2025-12-08
40
Participants Needed
2
Research Sites
609 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Zimmer Biomet Shoulder Arthroplasty PMCF Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 treatments are inadequate, or difficult clinical management problems where other treatments may not be suitable.
- 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 will not qualify if you...
- Patient is unwilling or unable to give consent or comply with follow-up.
- Patient has any condition that places them at undue risk or interferes with the study in the investigator's judgment.
- Patient is pregnant or breastfeeding.
- Patient is a vulnerable subject such as prisoner, mentally incompetent, known alcohol or drug abuser, or expected to be non-compliant.
- Patient is uncooperative or has neurologic disorders preventing following directions.
- Patient has infection affecting the shoulder joint or nearby area that may spread to the implant site.
- Patient has rapid joint destruction, marked bone loss, or bone resorption on X-ray.
- Patient has neuromuscular disease affecting the limb making the procedure unjustifiable.
- Patient has osteoporosis that may limit ability to support the implant.
- Patient has metabolic disorder impairing bone formation.
- Patient has osteomalacia.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
ARCUS Kliniken Pforzheim
Pforzheim, Germany, 75179
Active, Not Recruiting
2
Meander Medisch Centrum
Amersfoort, TZ, Netherlands, 3813
Actively Recruiting
Research Team
C
Carina Hafner
CONTACT
L
Lisa To
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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