JuggerStitch Device for Torn Meniscus

Recruiting at5 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Zimmer Biomet

Disqualifiers: Pregnancy, Infection, Vulnerable, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the JuggerStitch Meniscal Repair Device treatment?

The research suggests that all-inside suture devices, like the JuggerStitch, are generally effective for meniscal repair, as they have been shown to have better outcomes compared to other methods like meniscal arrows. These devices are designed to simplify the repair process and improve the strength of the repair, which can lead to better healing. ^{1 2 3 4 5}

Research Team

Kim Blick

Principal Investigator

Zimmer Biomet

Elliott Goff, PhD

Principal Investigator

Zimmer Biomet

Eligibility Criteria

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.

Inclusion Criteria

Willing and able to comply with the study procedures

I am over 18 years old and my bones have stopped growing.

Subject is able to read and understand the informed consent form (ICF) and has voluntarily provided written informed consent

Exclusion 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.

The subject is unwilling or unable to give consent or to comply with the follow-up program

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo meniscal repair using the JuggerStitch Device

Immediate (surgical procedure)

1 visit (in-person, surgical)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Pre-operatively, 6 weeks, 6 months, and 1 year post-surgery

Post-market surveillance

Data collection to confirm the safety and performance of the JuggerStitch Device

1 year

Treatment Details

Interventions

• JuggerStitch Meniscal Repair Device (Device)

Trial Overview 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.

Participant Groups

Group I: Meniscal repair Experimental Treatment 1 Intervention

Patients in need of meniscal repair

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead Sponsor

Trials

383

Recruited

67,800+

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business

Findings from Research

The TSS (two simple sutures) technique showed the least displacement after cyclic loading in meniscal root repairs, making it a strong option for minimizing movement at the repair site.

The modified Mason-Allen (MMA) technique demonstrated significantly higher ultimate failure loads compared to TSS and single double-locking loop (S-DLL) techniques, suggesting it may be a more robust option despite being technically more challenging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cyclic displacement after meniscal root repair fixation: a human biomechanical evaluation. LaPrade, RF., LaPrade, CM., Ellman, MB., et al.[2018]

In a study using a porcine model, various meniscal repair devices were tested for their load-to-failure characteristics, revealing that traditional double vertical stitches provided the highest load-to-failure at 113 N, while newer devices like the Meniscus Arrow and Clearfix screw showed significantly lower loads, indicating potential differences in their effectiveness.

The study highlighted that different devices have unique failure mechanisms, such as sutures breaking away from knots or devices pulling through the meniscus, suggesting that while material properties are important, they may not directly predict clinical outcomes in meniscal repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meniscal repair devices. Barber, FA., Herbert, MA.[2022]

The FasT-Fix suture device demonstrated a high success rate of 86% in repairing meniscal tears in a study of 42 repairs across 37 patients, with significant improvements in both objective and subjective knee function scores after an average follow-up of 24.3 months.

This all-inside repair technique was found to be safe, with no intra-articular or extra-articular complications reported, and it showed comparable efficacy to traditional meniscal repair methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meniscal repair using the FasT-Fix all-inside meniscal repair device. Haas, AL., Schepsis, AA., Hornstein, J., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cyclic displacement after meniscal root repair fixation: a human biomechanical evaluation. [2018]

2. Mexico pubmed.ncbi.nlm.nih.gov

[Results of all-inside arthroscopic meniscal sutures, mid-term review]. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Meniscal repair devices. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Meniscal repair using the FasT-Fix all-inside meniscal repair device. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

All-inside suture device is superior to meniscal arrows in meniscal repair: a prospective randomized multicenter clinical trial with 2-year follow-up. [2018]