JuggerStitch Post Market Clinical Follow-up Study

Launched by ZIMMER BIOMET · Jan 10, 2020

Keywords

ClinConnect Summary

The JuggerStitch Post Market Clinical Follow-up Study is a research project aimed at checking the safety and effectiveness of the JuggerStitch Device, which is used to repair meniscus tears in the knee. This study is important because it helps ensure that the device works well for patients who have these types of injuries. The study is currently recruiting participants who are 18 years or older and meet certain health criteria, such as having a meniscal tear that can be repaired and being able to understand the study procedures.

If you or a loved one participates in this trial, you will be asked to follow specific guidelines and attend follow-up appointments to monitor your recovery. Participants will need to provide informed consent, which means you will be given clear information about the study and must agree to take part. It's important to know that not everyone can join; for example, those with certain types of meniscus tears or active infections will be excluded. Overall, this study is a chance to help improve treatment options for knee injuries while ensuring patient safety.

Gender

ALL

Eligibility criteria

• 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.