Fracture Registry University Hospital Basel

NCT ID: NCT05684042

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

216 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-09

Study Completion Date

2033-06-30

Brief Summary

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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

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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.

Conditions

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Distal Radius Fracture

Keywords

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Fracture Database Fracture Classifications of the Distal Radius Quality assurance REDCap

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Murat Bilici

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Clinic for Orthopedics and Traumatology

Locations

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University Hospital Basel, Orthopedics and Traumatology

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Murat Bilici

Role: CONTACT

Phone: +41 61 556 51 12

Email: [email protected]

Ilona Ahlborn

Role: CONTACT

Phone: +41 79 75 33 724

Email: [email protected]

Facility Contacts

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Murat Bilici

Role: primary

Ilona Ahlborn

Role: backup

Other Identifiers

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2022-00921; mu22Bilici

Identifier Type: -

Identifier Source: org_study_id