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RecruitingNCT05684042Updated Dec 9, 2024

Fracture Registry University Hospital Basel

An observational study in Distal Radius Fracture, sponsored by University Hospital, Basel, Switzerland. Recruiting at 1 site in Switzerland. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-12-09.

Sponsored by University Hospital, Basel, Switzerland · Observational

From the registry’s dates

  • Started Jun 2022; still recruiting 4 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
216
Ages
16 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Distal Radius Fracture

Keywords

  • Fracture Database
  • Fracture Classifications of the Distal Radius
  • Quality assurance
  • REDCap
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's planned enrollment of 216 is above the median of 100 across 675 observational studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
216 participants (estimated)
Patient registry
No

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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: one time assessment at baseline

07

Study locations

1 of 1 sites recruiting
  • University Hospital Basel, Orthopedics and Traumatology
    Basel, 4031, Switzerland
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05684042
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Jan 13, 2023
Start date
Jun 9, 2022
Primary completion
Jun 2033 (estimated)
Completion
Jun 2033 (estimated)
Last update
Dec 9, 2024

Study contacts

Murat Bilici
Contact
murat.bilici@usb.ch
+41 61 556 51 12
Ilona Ahlborn
Contact
ilona.ahlborn@usb.ch
+41 79 75 33 724
Murat Bilici
principal investigator · University Hospital Basel, Clinic for Orthopedics and Traumatology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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