What side effects are associated with this type of intervention?

Common treatments for a torn meniscus, such as arthroscopic meniscal repair and partial meniscectomy, can have several side effects. Arthroscopic meniscal repair may lead to complications like infection, nerve damage, stiffness, and persistent pain. Partial meniscectomy can result in swelling, stiffness, and an increased risk of osteoarthritis in the long term. Non-surgical treatments like physical therapy generally have fewer side effects but may not be as effective in severe cases. The JuggerStitch Device, which facilitates meniscal tissue repair, aims to minimize these risks by promoting natural healing, though specific side effects related to this device are not detailed in the provided context.

What prior FDA approvals exist?

The FDA has approved several treatments for torn meniscus, primarily focusing on surgical interventions and biologic therapies. Arthroscopic partial meniscectomy and meniscal repair are common surgical procedures. Devices like the JuggerStitch, which facilitate meniscal tissue repair, are part of ongoing advancements in this field. While specific FDA approvals for devices similar to JuggerStitch are not detailed, the general approach includes using sutures and anchors to repair the meniscus. Additionally, biologic therapies such as platelet-rich plasma (PRP) are used to enhance healing, although their efficacy is still under investigation.

What other types of research exist?

Promising alternatives to the JuggerStitch Device for meniscal repair include: 1) Bioinductive implants, which promote tissue regeneration and healing, 2) Meniscal scaffolds, such as collagen or polyurethane-based scaffolds, which provide a framework for new tissue growth, and 3) Stem cell therapy, which uses mesenchymal stem cells to enhance repair and regeneration of the meniscal tissue. These methods are being explored for their potential to improve outcomes in meniscal repair.

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Device

JuggerStitch Device for Torn Meniscus

N/A

Recruiting

Research Sponsored by Zimmer Biomet

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

No Placebo-Only Group

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 below

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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:

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My knee injury involves complex tears in the meniscus that can't be surgically repaired.

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I have a tear in the non-blood supply area of my knee cartilage.

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I currently have an active infection.

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I am currently pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Meniscal repairExperimental Treatment1 Intervention

Patients in need of meniscal repair

0 / 5Eligibility criteria met

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.