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Идёт набор NCT06850818

Heidelberg Registry for Hip and Knee Joint Implants and Revisions

Наблюдательное Osteoarthritis 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Osteoarthritis, Arthroplasty. 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
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Endoprosthesis Registry Heidelberg (EPR-HD): Registry for the Analysis of Patients Following Primary Implantation or Revision Surgery of Artificial Joints in Hip and Knee Joint Pathologies

Обзор

The Endoprosthesis Registry Heidelberg (EPR-HD) is a clinical registry designed to systematically collect and analyze data from patients undergoing primary implantation or revision surgery of artificial hip and knee joints. The main objective of the registry is to evaluate long-term outcomes, complication rates, implant survival, and functional results associated with joint replacement procedures in patients with various hip and knee joint pathologies. By gathering comprehensive clinical data, EPR-HD aims to improve the understanding of patient outcomes after endoprosthetic procedures, identify potential factors influencing implant success, and support evidence-based improvements in surgical techniques and patient care. The registry includes adult patients treated at Heidelberg University Hospital, with data collected at multiple time points during routine clinical follow-up. This registry will contribute to the optimization of joint replacement strategies and promote high-quality patient care.

Подробное описание

The Endoprosthesis Registry Heidelberg (EPR-HD) is designed to provide comprehensive, long-term data on patients undergoing primary implantation or revision surgery of hip and knee endoprostheses. The registry aims to enhance the understanding of factors affecting the survival and functionality of joint implants, providing essential insights for optimizing surgical strategies and improving patient outcomes.

Hip and knee arthroplasty are among the most common orthopedic procedures worldwide, yet long-term data on implant performance and patient-specific risk factors remain limited. The EPR-HD registry addresses this knowledge gap by systematically collecting clinical data, including patient demographics, surgical details, implant characteristics, perioperative outcomes, and long-term follow-up results. Complication rates, reasons for revision, and functional outcomes such as mobility, pain levels, and quality of life will be assessed over time.

The registry includes adult patients treated at Heidelberg University Hospital who undergo either primary implantation or revision surgery of hip or knee joints due to various pathologies, including osteoarthritis, rheumatoid arthritis, and post-traumatic conditions. Data will be collected prospectively during routine clinical visits at standardized follow-up intervals (e.g., 1 year, 3 years and every 5 years postoperatively).

By evaluating real-world clinical outcomes, EPR-HD will contribute to identifying risk factors associated with implant failure and complications, supporting the development of evidence-based treatment protocols. The insights gained from this registry will promote high-quality care, optimize surgical decision-making, and improve the long-term success of joint replacement procedures in diverse patient populations

Первичные конечные точки

  • Survival analysis with the endpoint revision for any reason [Срок оценки: Preoperative, 1 year, 3 years, and every 5 years]
Вторичные конечные точки (6)
  • Knee Society Score [Срок оценки: preoperative, 1 year, 3 years and every 5 years]
  • Forgotten Joint Score [Срок оценки: preoperative, 1 year, 3 years and every 5 years]
  • Oxford Knee/Hip Score [Срок оценки: preoperative, 1 year, 3 years and every 5 years]
  • Harris Hip [Срок оценки: preoperative, 1 year, 3 years and every 5 years]
  • Tegner Activity Scale [Срок оценки: preoperative, 1 year, 3 years and every 5 years]
  • The University of California, Los Angeles (UCLA) Activity Score [Срок оценки: preoperative, 1 year, 3 years and every 5 years]

Критерии участия

Критерии включения

  • All patients undergoing hip or knee arthroplasty at our institution
  • All patients undergoing revision surgery following hip oder knee arthroplasty

Критерии исключения

  • Lack of prospective consent for study participation
  • Lack of capacity to provide informed consent
  • Minor status (underage)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Германия · 1 центр
  • University Hospital Heidelberg — Heidelberg

Идентификаторы

NCT: NCT06850818 · S-003/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗