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)
Clinical Success — 1 year 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.
Trial sites (6)
Facility
City
Region
Status
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
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.
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