JuggerStitch Post Market Clinical Follow-up Study
Start Date
9/25/2020
Completion Date
4/30/2026
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).
Detailed 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 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
JuggerStitch Meniscal Repair Device
Conditions
Locations
OrthoCarolina
Charlotte, North Carolina 28207
United States
OrthoVirginia, Inc.
Richmond, Virginia 23226
United States
Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy
Lyon, 69008
France
Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg
Magdeburg, 39120
Germany
Ichihara Hospital
Tsukuba, Ibaraki 300-3295
Japan
Tokyo Medical and Dental University Hospital of Medicine
Tokyo, 113-8519
Japan