Condition: Proximal Humerus Fracture · Posttraumatic Arthrosis After Humeral Head Fracture · Posttraumatic Necrosis of the Humeral Head · Sponsor: Zimmer Biomet
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.
This description comes directly from the study's public registry record.
Julie Nicoux · +33 06 72 61 35 02 · julie.nicoux@zimmerbiomet.com
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| Salamenca University Hospital | Salamanca, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05351112