JuggerStitch™ for Meniscal Repair Post Market Clinical Follow-up Study
Zimmer Biomet
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).
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 avascul…
Interventions
- DeviceJuggerStitch Meniscal Repair Device
Treatment of torn meniscus with JuggerStitch.
Locations (6)
- OrthoCarolinaCharlotte, North Carolina
- OrthoVirginia, Inc.Richmond, Virginia
- Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique SantyLyon
- Medizinische Fakultät der Otto-von-Guericke-Universität MagdeburgMagdeburg
- Ichihara HospitalTsukuba, Ibaraki
- Tokyo Medical and Dental University Hospital of MedicineTokyo