Status:
COMPLETED
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System
Lead Sponsor:
Zimmer Biomet
Conditions:
Proximal Humeral Fracture
Proximal Tibia Fractures
Eligibility:
All Genders
18+ years
Brief Summary
The study is a monocentric, retro- and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical be...
Detailed Description
The Zimmer® Plates and Screws System consists of temporary internal fixation devices comprised of plates and screws that provide management of fractures through interfragmentary compression and bone p...
Eligibility Criteria
Inclusion
- Patients having received one of the plates belonging to the Zimmer® Plates and Screws System, designed for temporary internal fixation to stabilize fractures during the normal healing process. In this study we will collect data specifically on Zimmer® Plates and Screws System plates belonging to the Diaphysis, Proximal Humerus and Proximal Tibia groups.
Exclusion
- Off-label use
- Patients under the age of 18
- Prisoners
- Severely comminuted fractures in which bone fragments are too small or numerous to adequately fix or maintain a reduced position
- Infection
- Metal sensitivity or intolerance
- Severe osteopenia and/or osteoporosis, or in the presence of marked or rapid bone absorption, metabolic bone disease, cancer, or any other tumor-like condition of the bone which may compromise fixation
- Sternal or spinal fractures
- Anatomical location in which the device would interfere with nerves, blood vessels, or other vital structures
- Patients with inadequate soft tissue coverage at the implant site
Key Trial Info
Start Date :
March 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 27 2024
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT05215613
Start Date
March 15 2023
End Date
March 27 2024
Last Update
February 25 2025
Active Locations (1)
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1
SC Clinica Ortopedica e Traumatologica II IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy, 40136