Phase
Condition
N/ATreatment
JuggerStitch Meniscal Repair Device
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject qualifies for meniscal repair based on the physical exam and medical historyand 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 hisinstructions and is able to participate in the follow-up program;
Subject is able to read and understand the informed consent form (ICF) and hasvoluntarily provided written informed consent.
Exclusion
Exclusion Criteria:
Meniscal tears in the avascular zone of meniscus;
Meniscal tears not suitable for repair because of the degree of damage(markedirregularity 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 whatparticipation to the study entails, a known alcohol or drug abuser, anticipated tobe non-compliant);
The subject is unwilling or unable to give consent or to comply with the follow-upprogram;
Subject meets any contraindications of the appropriate Instruction for Use.
Study Design
Study Description
Connect with a study center
Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy
Lyon, 69008
FranceSite Not Available
Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg
Magdeburg, 39120
GermanySite Not Available
Ichihara Hospital
Tsukuba-shi, Ibaraki-ken 300-3295
JapanSite Not Available
Tokyo Medical and Dental University Hospital of Medicine
Tokyo, 113-8519
JapanSite Not Available
OrthoCarolina
Charlotte, North Carolina 28207
United StatesSite Not Available
OrthoVirginia, Inc.
Richmond, Virginia 23226
United StatesSite Not Available
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