Fracture Registry University Hospital Basel

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05684042
• Other study ID #: 2022-00921; mu22Bilici
• Status: Recruiting
• Start date: June 9, 2022
• Est. completion date: June 2033

Study information

• Verified date: July 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Murat Bilici
• Phone: +41 61 556 51 12
• Email: murat.bilici[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: June 2033
• Est. primary completion date: June 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures
• Wrist Fractures

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Orthopedics and Traumatology	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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