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Clinical Trials in the USA / NCT04228367
Recruiting Not applicable

JuggerStitch Post Market Clinical Follow-up Study

NCT04228367 · tracked via the Priya Life Science USA tracker
Sponsor
Zimmer Biomet
Phase
Not applicable
Started
2020-09-25
Last updated
2025-11-12

Condition(s) studied

Meniscus Tear, TibialMeniscus Lesion

Investigational drug(s) / intervention(s)

JuggerStitch Meniscal Repair Device

JuggerStitch Meniscal Repair Device: Treatment of torn meniscus with JuggerStitch.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
OrthoCarolina Charlotte North Carolina Active Not Recruiting
OrthoVirginia, Inc. Richmond Virginia Active Not Recruiting
Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy Lyon France Recruiting
Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg Magdeburg Germany Recruiting
Ichihara Hospital Tsukuba Ibaraki Recruiting
Tokyo Medical and Dental University Hospital of Medicine Tokyo Japan Recruiting

More Zimmer Biomet trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04228367 on ClinicalTrials.gov ↗ ← All trials in the USA