Clinical trial NCT05684042: Fracture Registry University Hospital Basel
Official title: Fracture Database of the University Hospital Basel: A REDCap Assisted Reliability and Validity Study of Fracture Classifications of the Distal Radius
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Distal Radius Fracture
Keywords: Fracture Database
Fracture Classifications of the Distal Radius
Quality assurance
REDCap
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 216
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Number of discrepancies between the classifications of the expert group and the fracture database
timeFrame: one time assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Orthopedics and Traumatology
Study officials:
affiliation: University Hospital Basel, Clinic for Orthopedics and Traumatology
name: Murat Bilici
role: PRINCIPAL_INVESTIGATOR
References: