PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder 2.0 Fracture System

The study is a multicenter, 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 2.0 Fracture System (Implants and Instrumentation) when used for fracture shoulder arthroplasty. 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	NCT05351112
Lead Sponsor	Zimmer Biomet
Conditions	Proximal Humerus Fracture, Posttraumatic Arthrosis After Humeral Head Fracture, Posttraumatic Necrosis of the Humeral Head
Enrollment	78 participants
Start Date	2022-07-07
Primary Completion	2034-01-21 (estimated)
Study Completion	2034-01-21 (estimated)
Updated on ClinicalTrials.gov	2025-08-17