NCT06920459|Recruiting
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Sponsor study identifier
observational
50
2 countries
2
Study Start
April 29, 2025
Actual (reported)Primary Completion
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2, 2025
Actual (reported)April 9, 2025
Actual (reported)April 29, 2025
Actual (reported)June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
2 years
Frequency and Incidence of Adverse Events (Safety)
10 years
Euroqol Patient Quality of life (EQ-5D-5L)
10 years
Patients who are having primary total shoulder arthroplasty who will receive a Zimmer Biomet Total Shoulder Arthroplasty System
Total Shoulder Arthroplasty using the Alliance™ Glenoid implant
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
ARCUS Kliniken Pforzheim
Pforzheim, 75179, Germany
Meander Medisch Centrum
Amersfoort, TZ, 3813, Netherlands
Emilie Rohmer
Zimmer Biomet
First Submitted
April 2, 2025
First Posted
April 9, 2025
Study Start
April 29, 2025
Actual (reported)Primary Completion
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head
Radiographic Performance
10 years
Contact the study team to confirm eligibility.
Study Completion
June 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 8, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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