JuggerStitch Post Market Clinical Follow-up Study

Status Recruiting

Clinical Trial Summary

This study is a post-market follow-up study. The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (Instruction For Use).

Clinical Trial Description

This study is a post-market follow-up study to fulfil the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12/2 and the Medical Devices Regulation (MDR 2017/745). The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (IFU). The objectives of the study are to calculate the overall clinical success rate and the performance, and confirm the safety of the JuggerStitch Meniscal Repair Device. The primary endpoint of this study is defined by the absence of reoperation due to meniscal tear. This will be measured against the success criteria of the absence of reoperation in 90.2% of the cases at one year. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04228367
Study type	Interventional
Source	Zimmer Biomet
Contact	Elliott Goff, PhD
Phone	0041 79 222 23 08
Email	elliott.goff@zimmerbiomet.com
Status	Recruiting
Phase	N/A
Start date	September 25, 2020
Completion date	August 31, 2026

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