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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
Must not have
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
Meniscal tears in the avascular zone of meniscus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Summary
This trial aims to confirm the safety and effectiveness of the JuggerStitch Device, which is used to repair torn knee cartilage (meniscus). It targets patients with meniscal tears to help them avoid further knee surgeries by stitching the torn parts together.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My knee injury involves complex tears in the meniscus that can't be surgically repaired.
Select...
I have a tear in the non-blood supply area of my knee cartilage.
Select...
I currently have an active infection.
Select...
I am currently pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical Success
Secondary study objectives
Monitoring of Adverse Events to confirm safety of the meniscal repair device
Other study objectives
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for a torn meniscus include conservative management, physical therapy, and surgical interventions such as meniscal repair. Conservative management involves rest, ice, compression, and elevation (RICE) to reduce inflammation and pain.
Physical therapy aims to strengthen the muscles around the knee to provide better support and stability. Surgical interventions, like the JuggerStitch Device, facilitate meniscal tissue repair by suturing the torn edges of the meniscus together, promoting natural healing and preserving the meniscus' function.
This is crucial for patients as it helps maintain knee stability, reduces the risk of osteoarthritis, and improves long-term joint health.
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Who is running the clinical trial?
Zimmer BiometLead Sponsor
375 Previous Clinical Trials
67,429 Total Patients Enrolled
Kim BlickStudy ChairZimmer Biomet
Oliver Schätti, PhDStudy ChairZimmer Biomet
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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.
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