Recruiting

Observational Study

Sponsor:

Zimmer Biomet

Code:

NCT04228367

Conditions

Meniscus Tear, Tibial

Meniscus Lesion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JuggerStitch Meniscal Repair Device

Study Details

Brief summary:

This study is a post-market 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 repair according to the product labelling (Instruction For Use).

Conditions

Meniscus Tear, Tibial

Meniscus Lesion

Study ID

NCT04228367

Start date

Sep 25, 2020

Status verified date

Oct, 2025

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

104 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Meniscal repair

Patients in need of meniscal repair

Interventions

JuggerStitch Meniscal Repair Device

Treatment of torn meniscus with JuggerStitch.

Primary outcome measure

  • Clinical Success [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Elliott Goff, PhD

0041 79 222 23 08elliott.goff@zimmerbiomet.com

Lisa To

Lisa.To@zimmerbiomet.com

Locations

OrthoCarolina

Recruiting

Charlotte, North Carolina, United States, 28207

More Information

Sponsor

Zimmer Biomet

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Zimmer Biomet on 2025-10-14.