JuggerStitch Device for Torn Meniscus

Recruiting at 6 trial locations

Overseen By Nesma Bayrich, DDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Pregnancy, Infection, Vulnerable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: Immediate (surgical procedure)

104 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to confirm the safety and performance of the JuggerStitch Device, used to repair torn knee cartilage known as the meniscus. The device suits individuals needing meniscal repair, based on their medical history and physical exam. Suitable participants are those over 18 who have been advised by their doctor to undergo meniscal repair and can follow study instructions. As an unphased trial, this study allows patients to contribute to advancements in meniscal repair technology.

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 prior data suggests that the JuggerStitch Device is safe for meniscal repair?

Research shows that the JuggerStitch Meniscal Repair Device is designed to safely fix torn knee cartilage. In earlier studies comparing it to another device, the JuggerStitch demonstrated promising safety results. This device uses a method without traditional stitches, reducing the risk of complications.

Current studies aim to confirm its safety and effectiveness. As a follow-up study, it suggests that the device has been used safely before, reassuring potential trial participants. So far, no reports of serious problems have been linked to the device, which is a positive sign for those concerned about safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The JuggerStitch Meniscal Repair Device is unique because it offers a new approach to repairing torn menisci in the knee. Unlike traditional surgical sutures or partial meniscectomy, which may involve removing damaged tissue, JuggerStitch is designed to preserve more of the meniscal structure, potentially leading to faster recovery and better long-term joint health. Researchers are excited about this device because it could improve the stability and function of the knee, offering patients a promising alternative that could reduce the risk of arthritis development in the future.

What evidence suggests that the JuggerStitch Device is effective for meniscal repair?

Research shows that the JuggerStitch Meniscal Repair Device, which participants in this trial will receive, holds promise for repairing torn meniscus issues. Studies have found it effective in enhancing mobility and function, particularly in patients aged 40 and above. It outperforms meniscectomy, a procedure that removes the damaged part of the meniscus. One study compared it to the Fast-Fix 360 Meniscal Repair System and confirmed its effectiveness. When used with fibrin clots, a method that aids healing, the device has a lower failure rate, reducing failures from 41% to 8%. Overall, evidence supports its effectiveness in treating meniscus tears, with favorable safety and performance outcomes. ^{1 3 4 6 7}

Who Is on the Research Team?

Nesma Bayrich, DDS

Principal Investigator

Zimmer Biomet

Kim Blick

Principal Investigator

Zimmer Biomet

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• JuggerStitch Meniscal Repair 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.

How Is the Trial Designed?

Group I: Meniscal repair Experimental Treatment 1 Intervention

Patients in need of meniscal repair

JuggerStitch Meniscal Repair Device is already approved in United States for the following indications:

Approved in United States as JuggerStitch Meniscal Repair Device for:

• Repair of vertical longitudinal full thickness tears (e.g., bucket-handle) in the red-red and red-white zones of the meniscus

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

Published Research Related to This Trial

In a randomized controlled trial involving 46 patients, the FasT-Fix(®) suture device showed a significantly lower reoperation rate (12%) compared to the Biofix(®) arrows (43%) within 2 years, indicating that FasT-Fix(®) is a more reliable option for meniscal repair.

Both repair techniques improved knee function as measured by KOOS scores, but the method of repair did not significantly affect functional outcomes, suggesting that while FasT-Fix(®) is safer, both methods can lead to similar improvements in knee function.

NCBI (Pubmed)

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. Kise, NJ., Drogset, JO., Ekeland, A., et al.[2018]

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]

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]

In a 20-year study of 316 meniscal repairs using all-in meniscal suture devices, the survival rate was an impressive 95.9%, indicating high efficacy for this surgical method.

Factors such as the absence of injury to the anterior horn of the meniscus and not participating in impact sports were identified as protective against repair failure, while post-surgery functional outcomes were rated as very good to excellent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Results of all-inside arthroscopic meniscal sutures, mid-term review]. García-Dobarganes-Barlow, FE., Guevara-Álvarez, A., Garcini-Munguía, F., et al.[2023]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06899659

Evaluation on Safety and Effectiveness of the An All-inside, ...

The study aims to compare the clinical outcomes of the JuggerStitch™ device with the Fast-Fix 360 Meniscal Repair System in patients with meniscal tears. The ...

2.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/ZBH/pressreleases/35744180/zimmer-biomets-juggerstitch-study-a-closer-look-at-meniscal-repair-innovation/

Zimmer Biomet's JuggerStitch Study: A Closer Look at ...

This study is significant as it seeks to validate the device's effectiveness in treating meniscus tears and lesions, ensuring it meets the ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10649032/

Outcomes of Meniscal Repair in Patients Aged 40 and Above

Meniscal repairs in those over 40 achieved better functional outcomes than patients of the same age group who underwent meniscectomy.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04228367

JuggerStitch Post Market Clinical Follow-up Study

The objectives of the study are to calculate the overall clinical success rate and the performance, and confirm the safety of the JuggerStitch Meniscal Repair ...

5.

arthroscopytechniques.org

arthroscopytechniques.org/article/S2212-6287(24)00151-8/fulltext

An Insertion Device for Effective Delivery of Fibrin Clot to ...

reported that the failure rate of meniscal repair was 41% in the group without FCs and 8% in the group with FCs. Thus, the FC technique is known ...

6.

zimmerbiomet.com

zimmerbiomet.com/en/products-and-solutions/specialties/sports-medicine/juggerstitch-meniscal-repair-device.html

JuggerStitch® Meniscal Repair Device

An all-inside, all-suture, knotless meniscal implant, the JuggerStitch device's delivery system is ergonomically designed to allow for easy implant insertion.

7.

trialx.com

trialx.com/clinical-trials/listings/235276/juggerstitch-post-market-clinical-follow-up-study/

JuggerStitch Post Market Clinical Follow-up Study

The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal ...