Actively Recruiting
Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study
Led by Zimmer Biomet · Updated on 2026-06-08
50
Participants Needed
2
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to confirm the safety, performance, and clinical benefits of the Zimmer Biomet Shoulder Arthroplasty systems used in primary anatomic shoulder arthroplasty. It is a multicenter, prospective, non-controlled post market surveillance study focusing on patients with shoulder conditions such as osteoarthritis, fractures, rheumatoid arthritis, and other degenerative joint diseases. The study evaluates safety by monitoring adverse events and measures clinical benefits including pain, function, quality of life, and radiographic parameters. Participants will receive the Zimmer Biomet Total Shoulder Arthroplasty System, including the Alliance™ Glenoid implant, as part of their primary total shoulder arthroplasty procedure. The study does not include a control group and involves long-term follow-up to assess the device's performance and safety. The primary endpoint is improvement in the American Shoulder and Elbow Surgeons (ASES) shoulder score at 2 years, with secondary endpoints including adverse event frequency, quality of life assessments (EQ-5D-5L), and radiographic performance over 10 years. During the study, participants will be monitored for clinical outcomes such as pain relief, shoulder function, and quality of life through standardized assessments and imaging studies. Follow-up visits will continue up to 10 years to track safety and device performance. Researchers will collect data on adverse events and changes in radiographic parameters to evaluate long-term effects. Participants are expected to complete all required follow-up assessments and provide informed consent before joining.
CONDITIONS
Brief 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 non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Patient is a candidate due to rheumatoid arthritis.
- Patient is a candidate due to fractures of the proximal humerus where other treatments are inadequate.
- Patient is a candidate due to difficult clinical management problems unsuitable for other treatments.
- 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 would place them at undue risk or interfere with the study.
- Patient is known to be pregnant or breastfeeding.
- Patient is a vulnerable subject such as prisoner, mentally incompetent, known alcohol or drug abuser, or anticipated to be non-compliant.
- Patient is uncooperative or has neurologic disorders preventing following directions.
- Patient has signs of infection affecting the shoulder joint or nearby which may spread to the implant site.
- Patient has rapid joint destruction, marked bone loss, or bone resorption on roentgenogram.
- Patient has neuromuscular disease compromising the affected limb making surgery unjustifiable.
- Patient has osteoporosis that may limit their ability to support the implant.
- Patient has a metabolic disorder impairing bone formation.
- Patient has osteomalacia.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo total shoulder arthroplasty using the Alliance™ Glenoid implant as part of the Zimmer Biomet Total Shoulder Arthroplasty System.
1 surgical visit (in-person)
Duration - Up to 10 years
Participants are monitored for safety, pain, functional performance, quality of life, and radiographic parameters after surgery.
Regular follow-up visits over 10 years
Trial Site Locations
Total: 2 locations
1
ARCUS Kliniken Pforzheim
Pforzheim, Germany, 75179
Actively Recruiting
2
Meander Medisch Centrum
Amersfoort, TZ, Netherlands, 3813
Actively Recruiting
Research Team
C
Carina Hafner
L
Lisa To
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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