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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Older than 18 years and skeletally mature
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is to confirm the safety and performance of a device used to repair meniscuses.
Who is the study for?
This trial is for adults over 18 with a torn meniscus who are physically and mentally able to follow the study's procedures and attend follow-up appointments. Participants must understand and consent to the study. Those with certain types of complex meniscal tears, active infections, or pregnancy cannot join.Check my eligibility
What is being tested?
The JuggerStitch Meniscal Repair Device is being evaluated in this post-market study to confirm its safety and performance for repairing meniscal injuries as per product guidelines.See study design
What are the potential side effects?
While specific side effects are not listed, typical risks may include pain at the repair site, swelling, infection risk from surgery, or potential device failure leading to additional medical intervention.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 years old and my bones have stopped growing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Success
Secondary outcome measures
Monitoring of Adverse Events to confirm safety of the meniscal repair device
Other outcome measures
International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)
Lysholm Knee Scoring Scale
Tegner Activity Level Scale
Trial Design
1Treatment groups
Experimental Treatment
Group I: Meniscal repairExperimental Treatment1 Intervention
Patients in need of meniscal repair
Find a Location
Who is running the clinical trial?
Zimmer BiometLead Sponsor
373 Previous Clinical Trials
67,267 Total Patients Enrolled
Kim BlickStudy ChairZimmer Biomet
Oliver Schätti, PhDStudy ChairZimmer Biomet
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My knee injury involves complex tears in the meniscus that can't be surgically repaired.I have a tear in the non-blood supply area of my knee cartilage.I am over 18 years old and my bones have stopped growing.I am eligible for meniscal repair based on my doctor's examination and my medical history.I understand my doctor's explanations and can follow instructions for follow-up.I currently have an active infection.I am currently pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Meniscal repair
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are partaking in this trial?
"Indeed, clinicaltrials.gov indicates that this research is in need of volunteers. Initially posted on September 25th 2020, the study was recently revised on October 17th 2022. To date, 130 individuals are required to be recruited from two medical facilities for participation."
Answered by AI
Are there any available opportunities for volunteers to participate in this clinical investigation?
"The clinical trial data hosted on the website shows that this study is presently recruiting patients. It was first announced in September of 2020 and has been updated as recently as October 17th 2022."
Answered by AI
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