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Recruiting NCT04228367

JuggerStitch Post Market Clinical Follow-up Study

No phase Interventional Meniscus Tear, Tibial Meniscus Lesion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JuggerStitch Meniscal Repair Device.
Who it may be relevant to
Registry conditions: Meniscus Tear, Tibial, Meniscus Lesion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, France, Germany, Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Detailed 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.

Interventions

  • Device JuggerStitch Meniscal Repair Device
    Treatment of torn meniscus with JuggerStitch.

Primary outcome measures

  • Clinical Success [Time frame: 1 year]
Secondary outcome measures (1)
  • Monitoring of Adverse Events to confirm safety of the meniscal repair device [Time frame: 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • OrthoCarolina — Charlotte
  • OrthoVirginia, Inc. — Richmond
Japan · 2 centers
  • Ichihara Hospital — Tsukuba
  • Tokyo Medical and Dental University Hospital of Medicine — Tokyo
France · 1 center
  • Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy — Lyon
Germany · 1 center
  • Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg — Magdeburg

Identifiers

NCT: NCT04228367 · CMG2017-14SM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗