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Идёт набор NCT06532929

Sport Surgery Products Outcomes - A Post-market Follow-up

— Наблюдательное Sport Surgery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Orthopaedic surgeries (ankle), Orthopaedic surgeries (shoulder), Orthopaedic surgeries (knee), Orthopaedic surgeries.
Кому может быть актуально
Состояния в реестре: Sport Surgery. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Safety and Clinical Performance Assessment of Sport Surgery Products - A Post-market Clinical Follow-up

Обзор

Teknimed is currently conducting a post-market clinical follow-up which will confirm performance, safety and usability for all the Teknimed range of Sports products. TEKNIMED has developed several devices currently used in orthopaedic surgery. With the increasing use of these procedures, there is a need for real-life long-term safety and efficacy data on these products. The study is a retrospective and prospective global, single arm, non-controlled, multicentric, ambispective observational study. Patients will be followed as per local standard medical care of the site.

Подробное описание

It is admitted that:

* Bioabsorbable interference screws are frequently used for graft attachment in knee cruciate ligament reconstruction, * Bioabsorbable pins are indicated for the realignment and fixation of epiphyseal fractures, osteotomies, arthrodesis and bone grafts of toes, * Non-absorbable suture is usually used for the repair and the reinforcement of ligaments or tendons structures during surgery procedures, * Anchor devices are usually used for the repair of rotator cuff tendons and biceps tenodesis.

Furthermore, resorption properties of many available devices (screws, pins) that are marketed as bioabsorbable may be different and not always very well defined.

This retro-prospective study is performed to confirm the safety and performance of TEKNIMED sports surgery products in their current clinical use.

Studied products include - but are not restricted to - the following TEKNIMED products:

* EUROSCREW® NG * ISOFIX® * SUTUR'LINK® * A'LINK'S® * BIORESORBABLE PINS

And following associated TEKNIMED instrumentation:

* ACL Instrumentation * A'LINK'S® Instrumentation * STAINLESS STEEL PINS

Вмешательства

  • Устройство Orthopaedic surgeries (ankle)
    ankle lateral ligament reconstruction in ligamentoplasty procedures
  • Устройство Orthopaedic surgeries (shoulder)
    rotator cuff repair
  • Устройство Orthopaedic surgeries (knee)
    knee cruciate ligaments reconstruction in ligamentoplasty procedures
  • Устройство Orthopaedic surgeries
    rotator cuff repair or closure of capsule after arthroplasty surgery
  • Устройство Orthopaedic surgeries (foot)
    stabilization of metatarsal and phalangeal osteotomies during treatment of hallux

Первичные конечные точки

  • Evaluation of join function [Срок оценки: 4 years (until the lifetime of the device)]
  • Adverse event [Срок оценки: 5 years]
Вторичные конечные точки (6)
  • Pain level [Срок оценки: 4 years]
  • Antalgic consumption [Срок оценки: 4 years]
  • Patients' satisfaction [Срок оценки: 4 years]
  • Quality of patient life [Срок оценки: 4 years]
  • Radiological outcomes [Срок оценки: 4 years]
  • Devices and instrumentations usability [Срок оценки: Once, during surgery]

Критерии участия

Критерии включения

  • Be 18 years or older.
  • Be willing to sign an informed consent approved by IRB or EC (where applicable) or not being opposed to the use of their clinical data in the study (France)

For prospective inclusion:

\- Be considered for a surgery with one of the TEKNIMED sports surgery product comprised in this study.

For retrospective inclusion:

  • Have undergone a surgery with a TEKNIMED sports surgery product between the 1st January 2016 and the date of the site initiation visit.
  • Be informed of the study and not being opposed to the use of their clinical data in the study (France) or be willing to sign an informed consent during the first follow-up visit following the site initiation (when applicable).

Критерии исключения

  • Patients presenting one of the following conditions will not be included: under trusteeship or guardianship, pregnancy
  • Anyone of the contraindications mentioned in the respective IFU of each device under study

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 10 центров
  • Milaire — Aubenas
  • Centre Claude Bernard — Guilherand-Granges
  • Centre Mistral -Clinique Pasteur — Guilherand-Granges
  • Orthopole des 3 provinces — Brive-la-Gaillarde
  • Clinique Pasteur — Bergerac
  • Médipôle Toulouse — Toulouse
  • Clinique Chénieux — Limoges
  • Clinique St Privat — Boujan-sur-Libron
  • … и ещё 2 центра

Идентификаторы

NCT: NCT06532929 · SM01-TK-SPORTS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗