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).
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 defined by 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
104
Treatment of torn meniscus with JuggerStitch.
OrthoCarolina
Charlotte, North Carolina, United States
ACTIVE_NOT_RECRUITINGOrthoVirginia, Inc.
Richmond, Virginia, United States
ACTIVE_NOT_RECRUITINGRamsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy
Lyon, France
Clinical Success
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.
Time frame: 1 year
Monitoring of Adverse Events to confirm safety of the meniscal repair device
The safety of the system will be assessed by monitoring the frequency and incidence of adverse events
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg
Magdeburg, Germany
RECRUITINGIchihara Hospital
Tsukuba, Ibaraki, Japan
RECRUITINGTokyo Medical and Dental University Hospital of Medicine
Tokyo, Japan
RECRUITING