Powered Impaction and Broaching in Elderly Total Hip Arthroplasty
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: Total Hip Replacement with Automatic impaction and broaching device, Total Hip Replacement.
- Кому может быть актуально
- Состояния в реестре: Hip Arthroplasty Replacement, Gait Biomechanics, Surgeon Physiologic Stress. Базовые параметры: от 70 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
- Канада
- 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
Demonstrating the Effect of Powered Broaching and Impaction in Direct Anterior Total Hip Arthroplasty. A Multi-centre Comparison of Patients 70 Years and Older
Обзор
Placing the parts of a hip replacement requires substantial force. This can lead to additional stress on the surgeon as well as the bone. A device was developed to help reduce this stress. This study aims to see whether this device impacts implant positioning and the surrounding bone in patients 70 years and older. It also will investigate surgeon efficiency and how patients walk after surgery.
Подробное описание
Preparation of the femoral canal and acetabulum impaction have traditionally been accomplished with the use of a mallet and manual instruments. During manual broaching or impaction, force is transmitted with each mallet strike, which distributes horizontal forces to cortical bone. Excessive force and malalignment of instruments can lead to intraoperative fractures, or unrecognized fractures contributing to early failure of the total hip arthroplasty (THA). This risk can be elevated in direct anterior (DA) THA when exposure is compromised due to the minimally invasiveness of the approach. The advent of powered broaching devices which provide a consistent force and are more ergonomic, now provide an alternative to manual techniques. Despite its proposed benefits, it has yet to achieve widespread adoption.
The study aims to assess whether the use of a powered broaching device (KINCISE2) has an impact on intraoperative or early postoperative femoral or acetabular fractures in patients 70 years or older, when compared to traditional manual techniques in DA THA. Patients will be subgrouped based on femoral/acetabular bone quality/morphology. Secondary outcomes measured will consist of femoral canal fil, femoral version and acetabular cup-floor gap and gait analysis measures via markerless motion capture. Surgical efficiency will be measured via operative time, broaching/impaction time and surgical stress via biometric monitoring. PROMs will be measured via the short form Hip disability and Osteoarthritis Outcome Score (HOOS-Jr). Surgeons can use a standard OR table vs. a specialized traction table (HANA) and may use fluoroscopy or no intraoperative imaging.
Вмешательства
- Процедура Total Hip Replacement with Automatic impaction and broaching device
Total hip replacement with the use of an automatic impaction and broaching device - Процедура Total Hip Replacement
Total hip replacement without automatic impaction and broaching
Первичные конечные точки
- Incidence of Periprosthetic fracture [Срок оценки: 90 days]
Вторичные конечные точки (6)
- Gait analysis [Срок оценки: 90 days]
- Image based implant positioning [Срок оценки: 7 days]
- Surgical efficiency [Срок оценки: 1 day]
- Surgical stress as measured by heart rate [Срок оценки: 1 day]
- Surgical stress as measured by respiratory rate [Срок оценки: 1 day]
- Patient reported outcome measure [Срок оценки: 90 days]
Критерии участия
Критерии включения
- Patients 70 years or older undergoing total hip replacement
Критерии исключения
- Unable to undergo the informed consent process
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Канада · 2 центра
- Concordia Joint Replacement Group / Concordia Hospital — Winnipeg
- Nova Scotia Health — Halifax
Публикации
- Kutzer KM, Deckey DG, Florance JM, Rosas S, Mont MA, Seyler TM. Automatic Impactors in Total Hip Arthroplasty: A State-of-the-Art Review. J Arthroplasty. 2026 Jan;41(1):153-160.e1. doi: 10.1016/j.arth.2025.04.077. Epub 2025 May 6. PMID 40339939
Идентификаторы
NCT: NCT07747831 · DPS-Joints-2026-009