Меню
Идёт набор NCT06885359

CoCrMo LOCK Bipolar Femoral Heads FU

— Наблюдательное Femoral Fractures Hip Arthropathy

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Femoral Fractures, Hip Arthropathy. 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
Словения
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

A Post-market Study Evaluating Clinical and Safety Outcomes of Bipolar Hemiarthroplasty Using CoCrMo LOCK Bipolar Femoral Heads in Subjects With Hip Fracture

Обзор

Study design: monocentric, retrospective, observational and post-market clinical study. Purpose: To demonstrate the safety and performance of CoCrMo LOCK bipolar femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with CoCrMo LOCK bipolar femoral heads from 1st January 2023 onwards at the site in accordance with the indication for use of the product.

Подробное описание

The study is aiming to demoranstrate safety and performance of LOCK Bipolar femoral heads and will do it by considering the rate of revision of any prosthesis component and dislocation, by x-ray evaluation, by patient reported outcomes and walking/residential status. Patients are followed for 2 years after hemiarthroplasty and data are collected at 6 timepoints (pre-operative, intra-operative, at discharge, 4-months follow up, 12 months follow up and 24 months follow up).

Первичные конечные точки

  • Evaluation of the revision rate of CoCrMo LOCK Bipolar femoral heads at 24 months after surgery. [Срок оценки: At 24 months after intraoperative visit]
Вторичные конечные точки (8)
  • Evaluation of the dislocation rate (including close reduction) in subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after bipolar hemiarthroplasty [Срок оценки: At 24 months after intraoperative visit]
  • Evaluation of the revision incidence of any hip component for any reason at 24 months after bipolar hemiarthroplasty. [Срок оценки: At 24 months after intraoperative visit]
  • Evaluation of acetabular erosion (according to Baker classification) in subjects with CoCrMo LOCK Bipolar femoral heads at 12 months after Bipolar Hemiarthroplasty. [Срок оценки: At 12 months after intraoperative visit]
  • Assessment of Harris Hip Score (HHS) at 24 months after Bipolar Hemiarthroplasty with CoCrMo LOCK Bipolar femoral heads. [Срок оценки: At 24 months after intraoperative visit]
  • Assessment of Oxford Hip Score (OHS) completed by subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after Bipolar Hemiarthroplasty. [Срок оценки: At 24 months after intraoperative visit]
  • Assessment of Pain Likert-scale in subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after Bipolar Hemiarthroplasty. [Срок оценки: At 24 months after intraoperative visit]
  • Comparison between pre-operative and 4-month walking ability. [Срок оценки: Performed at preoperative visit and 4months follow up visit]
  • Comparison between pre-operative and 4-month residential status. [Срок оценки: Performed at preoperative visit and 4months follow up visit]

Критерии участия

Критерии включения

  • Displaced intracapsular hip fracture (Garden III-IV).
  • Subjects underwent a Bipolar Hemiarthroplasty with a CoCrMo LOCK Bipolar femoral head as per their Indication For Use from January 1st, 2023, onwards.
  • No concurrent joint disease at the time of the surgery.
  • Absence of severe cognitive dysfunction demonstrated by 3 or more correct answers on the Pfeiffer test.
  • Ability to ambulate independently with or without walking aids before surgery.
  • Subject willingness to participate.

Критерии исключения

  • Undisplaced or minimally displaced intracapsular hip fracture (Garden I-II).
  • Any CoCrMo LOCK Bipolar femoral head contraindication for use as reported in the current Instruction For Use.
  • Pathological fracture secondary to malignant disease.
  • Subjects with rheumatoid arthritis or symptomatic osteoarthritis.
  • Previous treatment to the same hip for a fracture at the time of the surgery.
  • Subjects who were deemed unsuitable for the surgical procedures by the anesthesiologist.
  • Severe cognitive dysfunction or cognitive impairment demonstrated by 2 or less correct answers on the Pfeiffer test.
  • Unable to walk before surgery (e.g., wheelchair or bed-ridden subjects).

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Словения · 1 центр
  • Splošna bolnišnica Celje — Celje

Идентификаторы

NCT: NCT06885359 · H-46

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗