PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder 2.0 Fracture System
Recruiting
Observational Study
Proximal Humerus Fracture
Posttraumatic Arthrosis After Humeral Head Fracture
Posttraumatic Necrosis of the Humeral Head
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
- 78 (estimated)
- Sponsor
- Zimmer Biomet · Industry
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About This Trial
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 assessm…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients 18 years or older and skeletally mature
* Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study
* Replacement of the proximal…
Contacts