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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
JuggerStitch Meniscal Repair Device
DeviceTreatment of torn meniscus with JuggerStitch.
Treatment groups
104 Participants
are divided into 1 treatment groupGroup A: Meniscal repairExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 yearSecondary outcomes
1
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 yearOther outcomes
1
Lysholm Knee Scoring Scale
The scale is used to evaluate the outcomes of meniscus surgery. It consists of items that measure: pain, instability, locking, swelling, limp, stair climbing, squatting, and need for support. Lowest and highest scores are 0 and 100 (better), respectively.
Time frame
Pre-operatively, 6 weeks, 6 months and 1 year post-surgery2
Tegner Activity Level Scale
The Tegner Activity Level Scale aims to provide a standardized method of grading work and sporting activities and complements Lysholm Knee Scoring Scale. The Scale is based on 10 levels with Level 10 being "Competitive Sports" and Level 0 being "Sick Leave".
Time frame
Pre-operatively, 6 weeks, 6 months and 1 year post-surgery3
International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)
The IKDC is used to measure symptoms, function, and sports activity for people with meniscal injuries. Lowest and highest (better) scores are 0 and 100, respectively.
Time frame
Pre-operatively, 6 weeks, 6 months and 1 year post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov