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Идёт набор NCT06888934

Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes With Lync

Без фазы С лечением Arthritis Foot Bone Alignment Defaults

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: Intervention with Lync device..
Кому может быть актуально
Состояния в реестре: Arthritis Foot, Bone Alignment Defaults. 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 →
Официальное название

Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes Using the Lync® Medical Device

Обзор

The "LYNC" clinical investigation aims to confirm the clinical benefits, performance and safety of the Lync® device when implanted in the toes for the treatment of arthritis and correction of bone misalignments. The main objective of the study is to confirm the clinical benefits of the Lync® device for the treatment of arthritis and the correction of bone alignment default, by evaluating the restoration of the functional capacities of the forefoot at 3 -4 months post-operative follow-up with AOFAS-LMIS score.

Подробное описание

The clinical evaluation demonstrates that the clinical benefits, performance and safety of the Lync® device when implanted in the toes for the treatment of arthritis are not covered by any clinical data on similar devices.

The "LYNC" clinical investigation aims to confirm the clinical benefits, performance and safety of the Lync® device on 76 cases (feet) when implanted in the toes for the treatment of arthritis and correction of bone misalignments.

The main objective of the study is to confirm the clinical benefits of the Lync® device for the treatment of arthritis and the correction of bone alignment default, by evaluating the restoration of the functional capacities of the forefoot at 3 -4 months post-operative follow-up with AOFAS-LMIS score as primary endpoint.

The secondary objectives of the study are:

* To confirm the clinical benefits of the Lync® device for the treatment of arthritis and the correction of bone alignment default in the toes, by evaluating the reduction in patient pain during the 3-4 month postoperative visit. * To confirm the clinical performance of the Lync® device for the treatment of arthritis and the correction of bone alignment default in the toes, by evaluating the radiographic parameters (bone consolidation) during the 3-4 month postoperative visit. * To confirm the safety of the Lync® device for the treatment of arthritis and the correction of bone alignment default in the toes, by evaluating the occurrence of adverse events, complications and device defects at the various postoperative follow-up visits.

The secondary endpoints associated with the secondary objective are:

* The change in the VAS score will be evaluated at the postoperative visit at 3-4 months compared to that at the preoperative visit. * The assessment of bone consolidation will be carried out at the post-operative visit at 3-4 months. An additional visit at 6 months, assessing bone union, will be carried out ifbone union has not occurred 3-4 months post-operatively, in accordance with theinvestigators' current practice. * The collection of adverse events and defects will be done throughout the follow-up by the surgeons thanks to questioning of the patient, assessments of clinical and radiographic examinations of the foot.

Вмешательства

  • Устройство Intervention with Lync device.
    Treatment of arthritis and/or correction of bone alignement default in the toes (mallet toes, claw toes, hammer toes) with Lync device.

Первичные конечные точки

  • EFAS (EUROPEAN FOOT AND ANKLE SOCIETY) score [Срок оценки: 3 to 4 post-operative months]
Вторичные конечные точки (3)
  • VAS (Visual Analogue Scale) pain score [Срок оценки: 3 to 4 post-operative months]
  • Bone consolidation [Срок оценки: 3 to 4 post-operative months]
  • occurrence of adverse events, complications, device defects [Срок оценки: through study completion, an average of 6 months]

Критерии участия

Критерии включения

  • Patient requiring treatment of arthritis and/or correction of bone alignement defaultin the toes (mallet toes, claw toes, hammer toes),
  • Use of the Lync® intramedullary osteosynthesis implantable medical device,
  • No associated surgical procedures except:▪Flexor release/tenotomy
  • MTP Arthrolysis / Extensor Lengthening
  • Tendon transfers
  • Phalangeal osteotomy
  • Adult patient,
  • Patient capable of respecting the prescriptions and recommendations of his surgeon,
  • Patient able to read and understand the information note and the consent form,
  • Patient able to sign a consent form.

Критерии исключения

  • Patient presenting a contraindication to the device under investigation;
  • Simultaneous participation in another clinical investigation protocol;
  • Adults subject to legal protection (judicial protection, curatorship, guardianship),persons deprived of their liberty, pregnant or breastfeeding women, minors

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
Другое

Центры проведения

Франция · 5 центров
  • Clinique Saint-Charles — Lyon
  • Polyclinique du Val de Saône — Mâcon
  • Centre Chirurgical ADR — Nancy
  • Clinique Mutualiste Catalane — Perpignan
  • Polyclinique Lyon Nord — Rillieux-la-Pape

Идентификаторы

NCT: NCT06888934 · 2024-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗