AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Zimmer Biomet Shoulder Arthroplasty PMCF Study

Recruitingn/aAges 20 Years - anyAllZimmer Biomet
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
๐Ÿ’Š

What it tests

  • Allianceโ„ข Glenoid
๐Ÿ“

Where

2 sites
ARCUS Kliniken Pforzheim
Pforzheim, Germany
Meander Medisch Centrum
Amersfoort, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy