Long-term Aseptic Revision & Advanced Hip Arthroplasty Database
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: Hip Arthropathy Associated With Other Conditions. Базовые параметры: Без ограничений · 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
- Бельгия
- 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
Long-term Follow-up of Patients Undergoing Aseptic Revision Hip Arthroplasty or Complex Primary Hip Arthroplasty Treated at University Hospitals Leuven
Обзор
Total hip arthroplasty (THA) volumes continue to rise each year as the population ages and indications broaden. Increasingly, younger patients require hip replacement for conditions beyond primary osteoarthritis or fractures. As a result, the number of revision procedures is growing and is expected to increase further. Prospective data collection within this population will enable us to address key uncertainties, particularly around optimal implant selection for complex primary and revision cases. In addition, establishing a structured prospective database will allow for systematic internal auditing for quality assurance. Even simple metrics - such as verifying whether every patient received a complete diagnostic infection workup before revision surgery - could immediately enhance service quality and inform improvements to clinical pathways.
Подробное описание
Total hip arthroplasty (THA) volumes continue to rise each year as the population ages and indications broaden. Increasingly, younger patients require hip replacement for conditions beyond primary osteoarthritis or fractures, including developmental dysplasia, avascular necrosis, post-traumatic deformities, and sequelae of childhood diseases such as femoro-acetabular impingement, septic arthritis, Legg-Calvé-Perthes disease, and slipped capital femoral epiphysis.
As a result, the number of revision procedures is growing and is expected to increase further. Two distinct patient groups drive this trend. First, individuals who received a primary THA in their 60s or 70s frequently require revision in their 80s or 90s, where reduced physiological reserve and multiple comorbidities create specific perioperative challenges. Second, patients who undergo THA at a young age - often due to congenital or childhood pathology - have a long life expectancy and a higher probability of needing revision surgery later on.
University Hospitals Leuven receive a substantial share of these complex cases, given our expertise in complex primary and revision hip arthroplasty and our multidisciplinary, patient-tailored approach.
However, the heterogeneity of these patients - due to varying indications, implant types, bone defects, and previous procedures - makes randomized controlled trials in this field difficult to conduct. Consequently, many clinical questions remain unresolved.
Prospective data collection within this population will enable us to address key uncertainties, particularly around optimal implant selection for complex primary and revision cases.
In addition, establishing a structured prospective database will allow for systematic internal auditing for quality assurance. Even simple metrics - such as verifying whether every patient received a complete diagnostic infection workup before revision surgery - could immediately enhance service quality and inform improvements to clinical pathways.
Первичные конечные точки
- Number of revision surgeries performed for any reason [Срок оценки: From enrollment to the end of the study, following 30 years of follow-up]
Вторичные конечные точки (12)
- Number of revision for aseptic loosening [Срок оценки: From enrollment to the end of the study, following 30 years of follow-up]
- Number of revision for periprosthetic joint infections (PJI) Dislocation [Срок оценки: From enrollment to the end of the study, following 30 years of follow-up]
- Overview of different treatments for periprosthetic fractures [Срок оценки: From enrollment to the end of the study, following a 30-year follow-up period]
- Overview of surgical complications [Срок оценки: From enrollment to the end of the study, following a 30-year follow-up period]
- Overview of medical complications [Срок оценки: From enrollment to the end of the study, following a 30-year follow-up period]
- Length of hospital stay for (aseptic revision) THA [Срок оценки: At the time of enrollment]
- Questionnaire about living situation [Срок оценки: From enrollment to the end of the study, following a 30-year follow-up period]
- EQ-5D-5L health questionnaire [Срок оценки: From enrollment to the end of the study, following a 30-year follow-up period]
- Hip disability and Osteoarthritis Outcome Score (HOOS) [Срок оценки: From enrollment to the end of the study, following a 30-year follow-up period]
- Oxford Hip Score [Срок оценки: From enrollment to the end of the study, following a 30-year follow-up period]
- Number of patient readmissions [Срок оценки: At the time of enrollment]
- Mortality rates [Срок оценки: From enrollment to the end of the study, following a 30-year follow-up period]
Критерии участия
Критерии включения
- Patients undergoing a hip replacement for the following indications:
- THA with hardware removal
- THA for hip dysplasia
- THA with femoral deformity or prior corrective surgery
- THA after LCPD, SCFE or septic arthritis
- THA in metabolic disease
- THA in hyperlaxity (e.g. Ehlers-Danlos syndrome, Down syndrome)
- THA with complex bony anatomy
- THA in patients aged 25 years or younger
- Other indications for which the treating surgeon expects increased surgical difficulty or increased risk of postoperative complications
Критерии исключения
- Patients unable to provide written informed consent
- Patients who prefer treatment outside of University Hospitals Leuven
- Patients with proven PJI according to the 2021 EBJIS criteria
- Patients undergoing standard, non-complex, hip replacement as judged by the treating physician.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Бельгия · 1 центр
- Universitaire Ziekenhuizen KU Leuven — Leuven
Идентификаторы
NCT: NCT07481448 · S71716