PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder Bipolar System
Recruiting
Observational Study
Revision of a Shoulder Prosthesis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 40 (estimated)
- Sponsor
- Zimmer Biomet · Industry
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About This Trial
The study is a monocentric, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect long-term data confirming safety, performance and clinical benefits of the Anatomical Shoulder Bipolar System (Implants and Instrumentation) when used as a salvage solution in shoulder replacement.
The primary objective is the …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. The Anatomical Should Bipolar Adaptor is indicated for hemi shoulder replacement as a salvage solution in situations, where a Zimmer Anatomical Shoulder Inverse/Reverse prosthesis was originally planned, but it is intra-operatively found that the attachment of the Zimmer Anat…
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