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ID04228367

JuggerStitch Device for Meniscal Repair Post-Market Follow-up Study Confirming Safety and Performance in Adults

Led by Zimmer Biomet · Updated on 2025-11-12

104

Participants Needed

6

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to confirm the safety and performance of the JuggerStitch Device used for meniscal repair. It is a post-market follow-up study designed to fulfill surveillance requirements under medical device regulations and directives. The study focuses on patients needing meniscal repair due to meniscus tears or lesions and evaluates the device according to its approved labeling. Participants will receive treatment using the JuggerStitch Meniscal Repair Device for torn meniscus. The study tracks clinical success primarily by checking for the absence of reoperation due to meniscal tear over one year. This device-focused study does not involve placebo or comparison groups and monitors adverse events to confirm safety throughout the study period. During the study, participants will be assessed over one year to measure clinical success and monitor adverse events. Researchers will collect data on the need for reoperation and any safety concerns related to the device. Participants must be willing and able to follow study procedures and attend follow-up visits as part of the monitoring program.

CONDITIONS

Brief Title

JuggerStitch Post Market Clinical Follow-up Study

Research Team

N

Nesma Bayrich, DDS

L

Lisa To

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