NCT04228367

JuggerStitch Post Market Clinical Follow-up Study

JuggerStitch™ for Meniscal Repair Post Market Clinical Follow-up Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Meniscus Tear, Tibial
• Meniscus Lesion

Interventions

Type	Name	Description
DEVICE	JuggerStitch Meniscal Repair Device	Treatment of torn meniscus with JuggerStitch.

Timeline

• Start date: 2020-09-25
• Primary completion: 2026-03-31
• Completion: 2026-04-30
• First posted: 2020-01-14
• Last updated: 2025-11-12

Locations

6 sites across 4 countries: United States, France, Germany, Japan

Regulatory

• FDA-regulated device study