PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System

Launched by ZIMMER BIOMET · Jan 28, 2022

Keywords

ClinConnect Summary

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 plating. In this study, the focus is on the Zimmer® Plates and Screws System used to stabilize diaphyseal, proximal humerus and proximal tibia fractures.

One site will be involved in this study. The aim is to include a maximum of 112 consecutive series cases who received the Zimmer® Plates and Screws System at the Istituto Ortopedico Rizzoli (Bologna, Italy) between 2008 and 2018. All potential...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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