Actively Recruiting
JuggerStitch™ for Meniscal Repair Post Market Clinical Follow-up Study
Led by Zimmer Biomet · Updated on 2025-11-12
104
Participants Needed
6
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to confirm the safety and performance of the JuggerStitch Device used for meniscal repair. It is a post-market follow-up study designed to fulfill surveillance requirements under medical device regulations and directives. The study focuses on patients needing meniscal repair due to meniscus tears or lesions and evaluates the device according to its approved labeling. Participants will receive treatment using the JuggerStitch Meniscal Repair Device for torn meniscus. The study tracks clinical success primarily by checking for the absence of reoperation due to meniscal tear over one year. This device-focused study does not involve placebo or comparison groups and monitors adverse events to confirm safety throughout the study period. During the study, participants will be assessed over one year to measure clinical success and monitor adverse events. Researchers will collect data on the need for reoperation and any safety concerns related to the device. Participants must be willing and able to follow study procedures and attend follow-up visits as part of the monitoring program.
CONDITIONS
Brief Title
JuggerStitch Post Market Clinical Follow-up Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient qualifies for meniscal repair based on physical exam and medical history and meets approved indications for the device
- Older than 18 years and skeletally mature
- Willing and able to comply with study procedures
- Able to understand doctor's explanations and participate in follow-up
- Able to read, understand, and voluntarily sign the informed consent form
You will not qualify if you...
- Meniscal tears in the avascular zone of meniscus
- Meniscal tears unsuitable for repair due to severe damage, including degenerative, radial, horizontal cleavage, or flap tears
- Presence of active infection
- Pregnant females
- Vulnerable individuals (prisoners, mentally incompetent, known alcohol or drug abusers, or expected non-compliant)
- Unwilling or unable to give consent or comply with follow-up
- Meets any contraindications listed in the device's Instructions for Use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure at enrollment
Participants receive treatment of torn meniscus with the JuggerStitch Meniscal Repair Device.
1 visit (in-person)
Duration - 1 year
Participants are monitored to confirm the safety and performance of the meniscal repair device and to assess clinical success over one year.
Follow-up visits over 1 year
Trial Site Locations
Total: 6 locations
1
OrthoCarolina
Charlotte, North Carolina, United States, 28207
Active, Not Recruiting
2
OrthoVirginia, Inc.
Richmond, Virginia, United States, 23226
Active, Not Recruiting
3
Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy
Lyon, France, 69008
Actively Recruiting
4
Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg
Magdeburg, Germany, 39120
Actively Recruiting
5
Ichihara Hospital
Tsukuba, Ibaraki, Japan, 300-3295
Actively Recruiting
6
Tokyo Medical and Dental University Hospital of Medicine
Tokyo, Japan, 113-8519
Actively Recruiting
Research Team
N
Nesma Bayrich, DDS
L
Lisa To
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here