跳至主要内容
临床试验/NCT06850818
NCT06850818招募中不适用

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

University Hospital Heidelberg1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2007年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
Survival analysis with the endpoint revision for any reason

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

结局指标

主要结局

Survival analysis with the endpoint revision for any reason

时间窗: Preoperative, 1 year, 3 years, and every 5 years

Kaplan Meier Analysis

次要结局

  • Knee Society Score(preoperative, 1 year, 3 years and every 5 years)
  • Forgotten Joint Score(preoperative, 1 year, 3 years and every 5 years)
  • Oxford Knee/Hip Score(preoperative, 1 year, 3 years and every 5 years)
  • Harris Hip(preoperative, 1 year, 3 years and every 5 years)
  • Tegner Activity Scale(preoperative, 1 year, 3 years and every 5 years)
  • The University of California, Los Angeles (UCLA) Activity Score(preoperative, 1 year, 3 years and every 5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mustafa Hariri

Principal Investigator

University Hospital Heidelberg

研究点 (1)

Loading locations...

相似试验