Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04228367

JuggerStitch Post Market Clinical Follow-up Study

Led by Zimmer Biomet · Updated on 2025-11-12

104

Participants Needed

6

Research Sites

291 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

JuggerStitch Post Market Clinical Follow-up Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

OrthoCarolina

Charlotte, North Carolina, United States, 28207

Active, Not Recruiting

2

OrthoVirginia, Inc.

Richmond, Virginia, United States, 23226

Active, Not Recruiting

3

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

Lyon, France, 69008

Actively Recruiting

4

Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg

Magdeburg, Germany, 39120

Actively Recruiting

5

Ichihara Hospital

Tsukuba, Ibaraki, Japan, 300-3295

Actively Recruiting

6

Tokyo Medical and Dental University Hospital of Medicine

Tokyo, Japan, 113-8519

Actively Recruiting

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Research Team

N

Nesma Bayrich, DDS

CONTACT

L

Lisa To

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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