JuggerStitch Post Market Clinical Follow-up Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Meniscus Tear, Tibial, Meniscus Lesion

Intervention / Treatment
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* Device: JuggerStitch Meniscal Repair Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meniscal repair<br>Patients in need of meniscal repair | Device: JuggerStitch Meniscal Repair Device<br>* Treatment of torn meniscus with JuggerStitch.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitoring of Adverse Events to confirm safety of the meniscal repair device | The safety of the system will be assessed by monitoring the frequency and incidence of adverse events | 1 year |