NCT05215613

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

PMCF Study to Provide Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System Applied for Diaphyseal, Proximal Humerus and Proximal Tibia Fractures (Implants and Instrumentation) - A Retro- and Prospective Consecutive Series Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 57 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 benefits of the Zimmer® Plates and Screws System (implants and instrumentation) when used to stabilize diaphyseal, proximal humerus and proximal tibia fractures. The primary objective is the assessment of performance by analyzing fracture healing. The secondary objectives are the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Subjects' outcomes will also be assessed.

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 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 study subjects will be required to participate in the Informed Consent process. Baseline data from the preoperative, intraoperative, immediate post-operative and last consultation visit at minimum 6 months post-operative will be available in medical notes and collected retrospectively. During a follow up phone call the subject will be asked to complete questionnaires and a clinical assessment of the fracture healing. In addition, any complications since the last consultation visit at the clinic and information about the treatment of the complications will also be collected over the phone.

Conditions

• Proximal Humeral Fracture
• Proximal Tibia Fractures
• Diaphyseal Fracture

Timeline

• Start date: 2023-03-15
• Primary completion: 2024-03-27
• Completion: 2024-03-27
• First posted: 2022-01-31
• Last updated: 2025-02-25
• Results posted: 2025-02-25

Locations

1 site across 1 country: Italy