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Recruiting NCT05684042

Fracture Registry University Hospital Basel

Observational Distal Radius Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data analysis: Accuracy measurement of the classifications of the distal radius fracture in the fracture database..
Who it may be relevant to
Registry conditions: Distal Radius Fracture. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other Data analysis: Accuracy measurement of the classifications of the distal radius fracture in the fracture database.
    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 outcome measures

  • Number of discrepancies between the classifications of the expert group and the fracture database [Time frame: one time assessment at baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • University Hospital Basel, Orthopedics and Traumatology — Basel

Identifiers

NCT: NCT05684042 · 2022-00921; mu22Bilici

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗