JuggerStitch Post Market Clinical Follow-up Study (NCT04228367) | Clinical Trial Compass
RecruitingNot Applicable
JuggerStitch Post Market Clinical Follow-up Study
United States, France, Germany104 participantsStarted 2020-09-25
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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.