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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05684042
Enrollment
216
Registered
2023-01-13
Start date
2022-06-09
Completion date
2033-06-30
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Radius Fracture

Keywords

Fracture Database, Fracture Classifications of the Distal Radius, Quality assurance, REDCap

Brief 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.

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

OTHERData 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.

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of discrepancies between the classifications of the expert group and the fracture databaseone time assessment at baselineNumber of discrepancies between the classifications of the expert group and the fracture database

Countries

Switzerland

Contacts

Primary ContactMurat Bilici
murat.bilici@usb.ch+41 61 556 51 12
Backup ContactIlona Ahlborn
ilona.ahlborn@usb.ch+41 79 75 33 724

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026