RecruitingNot ApplicableNCT04228367

JuggerStitch Post Market Clinical Follow-up Study

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

Sponsor

Zimmer Biomet

Enrollment

104 participants

Start Date

Sep 25, 2020

Study Type

INTERVENTIONAL

Conditions

Meniscus Lesion Meniscus Tear, Tibial

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Subject qualifies for meniscal repair based on the physical exam and medical history and meets the approved indications for use of the study product;
Older than 18 years and skeletally mature;
Willing and able to comply with the study procedures;
Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program;
Subject is able to read and understand the informed consent form (ICF) and has voluntarily provided written informed consent.

Exclusion Criteria7

Meniscal tears in the avascular zone of meniscus;
Meniscal tears not suitable for repair because of the degree of damage(marked irregularity and complex tearing) to the meniscus body including degenerative, radial, horizontal cleavage and flap tears;
Presence of active infection;
If female, subject is pregnant;
Subject is vulnerable (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant);
The subject is unwilling or unable to give consent or to comply with the follow-up program;
Subject meets any contraindications of the appropriate Instruction for Use.

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