An observational study in Shoulder Fractures, Shoulder Arthritis Osteoarthritis and Shoulder Injury, sponsored by Zimmer Biomet. Recruiting at 2 sites in 2 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Zimmer Biomet · Observational
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.
The primary endpoint for this study will be performance assessed by improvement in the American Shoulder and Elbow Surgeons (ASES) shoulder score from baseline to 2 years (as evaluated using the overall cohort mean showing at least the minimal clinically important difference (MCID) of 6.4 points).
The secondary endpoint is represented by the safety of the system, which will be assessed by monitoring the frequency and incidence of adverse events. The secondary endpoint evaluation will also assess the overall pain, functional performance, quality of life and radiographic parameters of all enrolled study subjects.
113 studies on the registry are indexed under Shoulder Fractures; 30 are open to participants now.
This study's planned enrollment of 50 is below the median of 97 across 60 observational studies indexed under Shoulder Fractures.
Browse Shoulder Fractures studies →Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
The Alliance Glenoid is intended to be used as part of an anatomic total shoulder arthroplasty to reduce shoulder pain an improve shoulder function. The Alliance Glenoid is intended to be used as a component of a total shoulder replacement system for primary arthroplasty. It provides the surface on the glenoid side that articulates with the modular head component and stem component on the humeral side. Patients must meet all inclusion and none on the exclusion criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who are having primary total shoulder arthroplasty who will receive a Zimmer Biomet Total Shoulder Arthroplasty System
Device: Alliance™ Glenoid
Total Shoulder Arthroplasty using the Alliance™ Glenoid implant
American Shoulder and Elbow Surgeons (ASES)
The primary endpoint for this study will be performance assessed by improvement in the American Shoulder and Elbow Surgeons (ASES) shoulder score from baseline to 2 years (as evaluated using the overall cohort mean showing at least the minimal clinically important difference (MCID) of 6.4 points). Pain, function, and activities of daily living are measured. The ASES scale is 0-100. 100 is the highest score and indicates the greatest function while 0 is the lowest score.
Time frame: 2 years
Frequency and Incidence of Adverse Events (Safety)
Monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.
Time frame: 10 years
Euroqol Patient Quality of life (EQ-5D-5L)
The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death.
Time frame: 10 years
Radiographic Performance
X-Rays will be evaluated for radiolucency, osteolysis, osteophytes, component migration, subsidence and heterotopic ossification.
Time frame: 10 years
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