JuggerStitch Post Market Clinical Follow-up Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZimmer Biomet
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- JuggerStitch Meniscal Repair Device
Treatment groups
104 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov