JuggerStitch Post Market Clinical Follow-up Study

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Clinical Success [Срок оценки: 1 year]

Вторичные конечные точки (1)

• Monitoring of Adverse Events to confirm safety of the meniscal repair device [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• OrthoCarolina — Charlotte
• OrthoVirginia, Inc. — Richmond

Япония · 2 центра

• Ichihara Hospital — Tsukuba
• Tokyo Medical and Dental University Hospital of Medicine — Tokyo

Франция · 1 центр

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

Германия · 1 центр

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

Идентификаторы

NCT: NCT04228367 · CMG2017-14SM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗