PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder Bipolar System

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 assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.

NCT Number	NCT05358574
Lead Sponsor	Zimmer Biomet
Conditions	Revision of a Shoulder Prosthesis
Enrollment	40 participants
Start Date	2022-04-22
Primary Completion	2033-07-16 (estimated)
Study Completion	2033-07-16 (estimated)
Updated on ClinicalTrials.gov	2025-11-25