NCT04228367

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).

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
4 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

September 25, 2020

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

5.5 years

First QC Date

January 10, 2020

Last Update Submit

November 10, 2025

Conditions

Meniscus Tear, TibialMeniscus Lesion

Outcome Measures

Primary Outcomes (1)

  • Clinical Success

    The absence of reoperation due to meniscal tear. This will be measured against the success criteria of the absence of reoperation in 90.2% of the cases at one year.

    1 year

Secondary Outcomes (1)

  • Monitoring of Adverse Events to confirm safety of the meniscal repair device

    1 year

Other Outcomes (3)

  • Lysholm Knee Scoring Scale

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

  • Tegner Activity Level Scale

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

  • International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)

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

Study Arms (1)

Meniscal repair

EXPERIMENTAL

Patients in need of meniscal repair

Device: JuggerStitch Meniscal Repair Device

Interventions

JuggerStitch Meniscal Repair DeviceDEVICE

Treatment of torn meniscus with JuggerStitch.

Meniscal repair

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

OrthoCarolina

Charlotte, North Carolina, 28207, United States

ACTIVE NOT RECRUITING

OrthoVirginia, Inc.

Richmond, Virginia, 23226, United States

ACTIVE NOT RECRUITING

Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy

Lyon, 69008, France

RECRUITING

Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg

Magdeburg, 39120, Germany

RECRUITING

Ichihara Hospital

Tsukuba, Ibaraki, 300-3295, Japan

RECRUITING

Tokyo Medical and Dental University Hospital of Medicine

Tokyo, 113-8519, Japan

RECRUITING

MeSH Terms

Conditions

Tibial Meniscus Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Nesma Bayrich, DDS

    Zimmer Biomet

    STUDY CHAIR

  • Kim Blick

    Zimmer Biomet

    STUDY CHAIR

Central Study Contacts

Nesma Bayrich, DDS

CONTACT

+41 793001484Nesma.bayrich@zimmerbiomet.com

Lisa To

CONTACT

Lisa.To@zimmerbiomet.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2020

First Posted

January 14, 2020

Study Start

September 25, 2020

Primary Completion

March 31, 2026

Study Completion

April 30, 2026

Last Updated

November 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

JP(2)US(2)FR(1)DE(1)