Follow-up on the JuggerStitch Device for meniscus repair

JuggerStitch™ for Meniscal Repair Post Market Clinical Follow-up Study

This study is testing how well the JuggerStitch device works for repairing meniscus tears in patients and whether it keeps them from needing more surgery within a year.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zimmer Biomet (Industry-sponsored)
• Locations: 6 sites (Charlotte, North Carolina and 5 other locations)
• Trial ID: NCT04228367 on ClinicalTrials.gov

What this trial studies

This post-market follow-up study aims to confirm the safety and performance of the JuggerStitch Meniscal Repair Device used for treating meniscus tears. It will collect data to assess the overall clinical success rate and ensure compliance with medical device regulations. The primary endpoint is the absence of reoperation due to meniscal tear within one year, with a target success rate of 90.2%. The study will involve patients who meet specific eligibility criteria related to their meniscal injuries.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who require meniscal repair and meet the approved indications for the JuggerStitch Device.

Not a fit: Patients with meniscal tears in the avascular zone or those with severe damage to the meniscus may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide evidence supporting the effectiveness and safety of the JuggerStitch Device, potentially leading to improved treatment options for patients with meniscus tears.

How similar studies have performed: Other studies on meniscal repair devices have shown promising results, indicating that this approach is supported by prior successful outcomes.

Eligibility criteria

Inclusion Criteria:

* Subject qualifies for meniscal repair based on the physical exam and medical history and meets the approved indications for use of the study product;
* Older than 18 years and skeletally mature;
* Willing and able to comply with the study procedures;
* Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program;
* Subject is able to read and understand the informed consent form (ICF) and has voluntarily provided written informed consent.

Exclusion Criteria:

* Meniscal tears in the avascular zone of meniscus;
* 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;
* Presence of active infection;
* If female, subject is pregnant;
* Subject is vulnerable (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant);
* The subject is unwilling or unable to give consent or to comply with the follow-up program;
* Subject meets any contraindications of the appropriate Instruction for Use.

Where this trial is running

Charlotte, North Carolina and 5 other locations

• OrthoCarolina — Charlotte, North Carolina, United States (Active_not_recruiting)
• OrthoVirginia, Inc. — Richmond, Virginia, United States (Active_not_recruiting)
• Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy — Lyon, France (Recruiting)
• Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg — Magdeburg, Germany (Recruiting)
• Ichihara Hospital — Tsukuba, Ibaraki, Japan (Recruiting)
• Tokyo Medical and Dental University Hospital of Medicine — Tokyo, Japan (Recruiting)

Study contacts

• Study coordinator: Nesma Bayrich, DDS

Conditions Meniscus Tear, Tibial; Meniscus Lesion