NCT04228367 JuggerStitch Post Market Clinical Follow-up Study
| NCT ID | NCT04228367 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zimmer Biomet |
| Condition | Meniscus Tear, Tibial |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2020-09-25 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 104 participants in total. It began in 2020-09-25 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Nesma Bayrich, DDS
STUDY CHAIR
Zimmer Biomet
Frequently Asked Questions
Who can join the NCT04228367 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Meniscus Tear, Tibial. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04228367 currently recruiting?
Yes, NCT04228367 is actively recruiting participants. Contact the research team at Nesma.bayrich@zimmerbiomet.com for enrollment information.
Where is the NCT04228367 trial being conducted?
This trial is being conducted at Charlotte, United States, Richmond, United States, Lyon, France, Magdeburg, Germany and 2 additional locations.
Who is sponsoring the NCT04228367 clinical trial?
NCT04228367 is sponsored by Zimmer Biomet. The principal investigator is Nesma Bayrich, DDS at Zimmer Biomet. The trial plans to enroll 104 participants.