Меню
Идёт набор NCT05397210

Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock Button System for Acromioclavicular Joint Stabilisation

— Наблюдательное Acromioclavicular; Dislocation

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: Infinity-Lock Button System.
Кому может быть актуально
Состояния в реестре: Acromioclavicular; Dislocation. Базовые параметры: от 16 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
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock™ Button System for Acromioclavicular Joint Stabilisation

Обзор

This is a Post-market Clinical Follow-up Study. It will verify the long-term safety and performance of the Infinity-Lock Button System (ILBS) when used for acute and chronic dislocations of the Acromioclavicular Joint and used as described by the manufacturer's instructions.

Подробное описание

This is a Post-market Clinical Follow-up Study. It will verify the long-term safety and performance of the Infinity-Lock Button System (ILBS) when used for acute and chronic dislocations of the Acromioclavicular Joint and used as described by the manufacturer's instructions.

The medical device (ILBS) in this study is already on the market and is manufactured by Xiros Ltd.

The ILBS comprises of a polyester flexible tubular tape and a titanium button. The tape is used to secure the joint and the button is used to secure the tape into position.

This study will collect data on patients who meet the entry criteria and receive the device; it will recruit patients from several clinical sites.

All patients in the study will receive the ILBS, as it is a single armed study. The total length of the study is expected to be 4.5 years; this includes a recruitment period of approximately 18 months and a 3-year follow-up.

A total of 58 subjects will be enrolled into the study. Follow up is at 3 months, 6 months, 1,2 and 3 years.

Вмешательства

  • Устройство Infinity-Lock Button System
    Infinity-Lock Button System

Первичные конечные точки

  • Constant Murley Score (CMS) [Срок оценки: 1 year]
  • Device Related or Procedure Related Adverse events [Срок оценки: 1 year]
Вторичные конечные точки (7)
  • Constant Murley Score (CMS) [Срок оценки: 3 years]
  • American Shoulder and Elbow Surgeons Score (ASES) [Срок оценки: 3 years]
  • RAND Short Form 36 (SF-36) V1 [Срок оценки: 3 years]
  • Nottingham Clavicle Score (NCS) [Срок оценки: 3 years]
  • Ability to perform normal daily work and normal recreational activities [Срок оценки: 3 years]
  • coracoclavicular distance [Срок оценки: 1 year]
  • Device-related and/or procedure-related adverse events [Срок оценки: 3 years]

Критерии участия

Критерии включения

  • Patient must be 16 years old or above.
  • Patient is diagnosed with acute or chronic Grade Ill-VI ACJ dislocation.
  • Patient is willing to participate in the study and have been informed of the nature of the study, agree to its follow-up and have provided written informed consent as approved by the Research Ethics Committee (REC).

Exclusion criteria.

  • Known hypersensitivity to implant materials. If the patient is suspected of having any foreign body sensitivity, appropriate tests should be made prior to implantation.
  • Infections or any other structural or pathological condition of the bone or soft tissue (such as hyperlaxity) that would be expected to impair healing or secure fixation.
  • Patients unable or unwilling to restrict activities to prescribed levels or follow a rehabilitation programme during the healing period.
  • Skeletally immature patients are not suited as the Infinity-Lock™ Button System will not elongate with growth. The use of this medical device and placement of hardware or implants must not bridge, disturb or disrupt the growth plate.
  • Any other conditions or factors which in the opinion of the Investigator may interfere with study conduct.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Великобритания · 4 центра
  • East Kent Hospitals University NHS Foundation Trust, — Canterbury
  • Barts Health NHS Trust — London
  • Nottingham University Hospitals — Nottingham
  • Royal Berkshire NHS Foundation Trust — Reading

Идентификаторы

NCT: NCT05397210 · CRE 019

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗