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NCT Number: NCT05684042

Fracture Registry University Hospital Basel

The primary goal of this research project is to measure the accuracy of the classifications of the distal radius fracture in the fracture database. The evaluation of the extracted data analyzes the validity of the fracture classifications that the medical staff carry out in everyday clinical practice.

Endpoint of this project is the reclassification of the selected fractures by an in-house group of experts in order to be able to carry out a subsequent statistical evaluation. It is analyzed whether there are significant deviations between the classifications of the expert group and the fracture database.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Since 2017, a fracture database has been developed in the Department of Orthopedics and Traumatology at the University Hospital in Basel. Since November 2018, all patients who are treated surgically in the Clinic for Traumatology & Orthopedics due to fractures of the extremities or the pelvis have been included in the fracture database of the University Hospital Basel for quality assurance purposes.

This database was created with the research software REDCap and is used for internal quality measurement. It essentially consists of three instruments: the encoded patient data, the diagnosis and the therapy. In order to promote rapid digitized progress in the health care system, the quality of the recorded data must be checked regularly through suitable studies. This type of quality management is of essential scientific relevance for the fracture database of the University Hospital Basel. For this reason, the classifications of the recorded fractures in the database are to be examined on a random basis so that weak points in the system can be addressed and staff can be better trained. The primary goal of the project is to measure the accuracy of the classifications of the distal radius fracture in the fracture database. The evaluation of the extracted data analyzes the validity of the fracture classifications that the medical staff carry out in everyday clinical practice.

Endpoint of this project is the reclassification of the selected fractures by an in-house group of experts in order to be able to carry out a subsequent statistical evaluation. It is analyzed whether there are significant deviations between the classifications of the expert group and the fracture database.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients at least 16 years of age and regardless of gender
  • Surgical treatment of a primary fracture of the distal radius was performed
  • Pre-therapeutic radiographs of good quality and in two planes
  • General consent for quality assurance and research was not rejected

Exclusion criteria

  • Existence of a documented refusal
  • Patients under the age of 16, as they are treated in the children's hospital
  • Conservative treatment of the distal radius fracture
  • Re-fracture after conservative or surgical treatment
  • Incorrect planes and poor quality of X-rays
  • Exclusive performance of a computed tomography, e.g. after polytrauma
  • Duplicates within the database
  • X-rays with forearm cast

Treatment and study plan

Data analysis: Accuracy measurement of the classifications of the distal radius fracture in the fracture database.

Other

An expert panel (3 in-house experienced specialists) carries out a new fracture classification based on the anonymous radiological images in the interface of the REDCap fracture database. The degree of discrepancy between the expert panel and the database in fracture classifications is analyzed. By evaluating the extracted data, it is analyzed how valid the quality of the collected fracture classifications are, which the medical staff carry out in everyday clinical practice.

Primary outcomes

  1. Number of discrepancies between the classifications of the expert group and the fracture database

    Time frame: one time assessment at baseline

    Number of discrepancies between the classifications of the expert group and the fracture database

Study contacts

Contact information is provided by the study sponsor or research team.

Ilona Ahlborn

CONTACT

[email protected]

+41 79 75 33 724

Murat Bilici

CONTACT

[email protected]

+41 61 556 51 12

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Fracture Database of the University Hospital Basel: A REDCap Assisted Reliability and Validity Study of Fracture Classifications of the Distal Radius

Important dates

Study start
2022
Primary completion
2033
Study completion
2033
First posted
Jan 13, 2023
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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