Fracture Registry University Hospital Basel

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

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.

Study Overview

• Status: Recruiting
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Other: Data analysis: Accuracy measurement of the classifications of the distal radius fracture in 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.

• Study Type: Observational
• Enrollment (Estimated): 216

Contacts and Locations

• Study Contact: Name: Murat Bilici; Phone Number: +41 61 556 51 12; Email: murat.bilici@usb.ch
• Study Contact Backup: Name: Ilona Ahlborn; Phone Number: +41 79 75 33 724; Email: ilona.ahlborn@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • University Hospital Basel, Orthopedics and Traumatology
    • Contact: Murat Bilici; Phone Number: +41 61 556 51 12; Email: murat.bilici@usb.ch
    • Contact: Ilona Ahlborn; Phone Number: +41 79 75 33 724; Email: ilona.ahlborn@usb.ch
    • Principal Investigator: Murat Bilici

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The health-related and personal data and all image material (X-rays) come from patients who were treated for surgical treatment of a distal radius fracture in the Clinic for Traumatology & Orthopedics at the University Hospital Basel. The REDCap database has been a tool for quality assurance in patient care at the USB since November 2018. The medical staff records all relevant data on a daily basis and archives it under data protection guidelines.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of discrepancies between the classifications of the expert group and the fracture database	Number of discrepancies between the classifications of the expert group and the fracture database	one time assessment at baseline

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Murat Bilici, University Hospital Basel, Clinic for Orthopedics and Traumatology

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Estimated): June 1, 2033
• Study Completion (Estimated): June 1, 2033

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: REDCap; Quality assurance; Fracture Database; Fracture Classifications of the Distal Radius
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Wrist Injuries; Wrist Fractures; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: 2022-00921; mu22Bilici

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No