Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06920459

Zimmer Biomet Shoulder Arthroplasty PMCF Study

Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study

Status
Recruiting
Phase
—
Study type
Observational
Enrollment
40 (estimated)
Sponsor
Zimmer Biomet · Industry
Sex
All
Age
20 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DEVICEAlliance™ GlenoidTotal Shoulder Arthroplasty using the Alliance™ Glenoid implant

Timeline

Start date
2025-04-29
Primary completion
2028-12-31
Completion
2036-12-31
First posted
2025-04-09
Last updated
2025-12-08

Locations

2 sites across 2 countries: Germany, Netherlands

Source: ClinicalTrials.gov record NCT06920459. Inclusion in this directory is not an endorsement.