JuggerStitch Post Market Clinical Follow-up Study

Last updated: September 3, 2024
Sponsor: Zimmer Biomet
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

JuggerStitch Meniscal Repair Device

Clinical Study ID

NCT04228367
CMG2017-14SM
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject qualifies for meniscal repair based on the physical exam and medical historyand 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 hisinstructions and is able to participate in the follow-up program;

  • Subject is able to read and understand the informed consent form (ICF) and hasvoluntarily provided written informed consent.

Exclusion

Exclusion Criteria:

  • Meniscal tears in the avascular zone of meniscus;

  • Meniscal tears not suitable for repair because of the degree of damage(markedirregularity 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 whatparticipation to the study entails, a known alcohol or drug abuser, anticipated tobe non-compliant);

  • The subject is unwilling or unable to give consent or to comply with the follow-upprogram;

  • Subject meets any contraindications of the appropriate Instruction for Use.

Study Design

Total Participants: 104
Treatment Group(s): 1
Primary Treatment: JuggerStitch Meniscal Repair Device
Phase:
Study Start date:
September 25, 2020
Estimated Completion Date:
August 31, 2026

Study Description

This study is a post-market follow-up study to fulfil the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12/2 and the Medical Devices Regulation (MDR 2017/745). 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 (IFU).

The objectives of the study are to calculate the overall clinical success rate and the performance, and confirm the safety of the JuggerStitch Meniscal Repair Device. The primary endpoint of this study is defined by 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.

Connect with a study center

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

    Lyon, 69008
    France

    Site Not Available

  • Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg

    Magdeburg, 39120
    Germany

    Site Not Available

  • Ichihara Hospital

    Tsukuba-shi, Ibaraki-ken 300-3295
    Japan

    Site Not Available

  • Tokyo Medical and Dental University Hospital of Medicine

    Tokyo, 113-8519
    Japan

    Site Not Available

  • OrthoCarolina

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • OrthoVirginia, Inc.

    Richmond, Virginia 23226
    United States

    Site Not Available

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