RECRUITING

JuggerStitch Post Market Clinical Follow-up Study

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Conditions

Meniscus Tear, TibialMeniscus Lesion

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2020-09-25
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04228367

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject qualifies for meniscal repair based on the physical exam and medical history and meets the approved indications for use of the study product;
  2. * Older than 18 years and skeletally mature;
  3. * Willing and able to comply with the study procedures;
  4. * Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program;
  5. * Subject is able to read and understand the informed consent form (ICF) and has voluntarily provided written informed consent.
  1. * Meniscal tears in the avascular zone of meniscus;
  2. * 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;
  3. * Presence of active infection;
  4. * If female, subject is pregnant;
  5. * 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);
  6. * The subject is unwilling or unable to give consent or to comply with the follow-up program;
  7. * Subject meets any contraindications of the appropriate Instruction for Use.

Contacts and Locations

Study Contact

Elliott Goff, PhD
CONTACT
0041 79 222 23 08
elliott.goff@zimmerbiomet.com
Lisa To
CONTACT
Lisa.To@zimmerbiomet.com

Principal Investigator

Elliott Goff, PhD
STUDY_CHAIR
Zimmer Biomet
Kim Blick
STUDY_CHAIR
Zimmer Biomet

Study Locations (Sites)

OrthoCarolina
Charlotte, North Carolina, 28207
United States
OrthoVirginia, Inc.
Richmond, Virginia, 23226
United States

Collaborators and Investigators

Sponsor: Zimmer Biomet

  • Elliott Goff, PhD, STUDY_CHAIR, Zimmer Biomet
  • Kim Blick, STUDY_CHAIR, Zimmer Biomet

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-25
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2020-09-25
Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Meniscus Tear, Tibial
  • Meniscus Lesion