Clinical trial NCT06850818: Heidelberg Registry for Hip and Knee Joint Implants and Revisions
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis
Arthroplasty
Keywords: Endoprostheses
Arthroplasty
Joint Replacement
Osteoarthritis
Registry
Knee
Hip
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing surgery at the Department of Orthopedic Surgery, Heidelberg University Hospital.

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Survival analysis with the endpoint revision for any reason
timeFrame: Preoperative, 1 year, 3 years, and every 5 years
Secondary outcomes:
measure: Knee Society Score
timeFrame: preoperative, 1 year, 3 years and every 5 years
measure: Forgotten Joint Score
timeFrame: preoperative, 1 year, 3 years and every 5 years
measure: Oxford Knee/Hip Score
timeFrame: preoperative, 1 year, 3 years and every 5 years
measure: Harris Hip
timeFrame: preoperative, 1 year, 3 years and every 5 years
measure: Tegner Activity Scale
timeFrame: preoperative, 1 year, 3 years and every 5 years
measure: The University of California, Los Angeles (UCLA) Activity Score
timeFrame: preoperative, 1 year, 3 years and every 5 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
state: Baden-Württemberg
Study officials:
References: