Distal Radius FractureNCT05684042
Fracture Registry University Hospital Basel
An observational study of Distal Radius Fracture, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Data analysis: Accuracy measurement of the classifications of the distal radius fracture in the fracture database.
- How many people
- 216 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Jun 2022to Jun 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel, Orthopedics and Traumatology
Basel, 4031
Murat Bilici, +41 61 556 51 12, murat.bilici@usb.ch
Ilona Ahlborn, +41 79 75 33 724, ilona.ahlborn@usb.ch
About this study
Official title: Fracture Database of the University Hospital Basel: A REDCap Assisted Reliability and Validity Study of Fracture Classifications of the Distal Radius
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.
- Conditions
- Distal Radius Fracture
- Being tested
- Data analysis: Accuracy measurement of the classifications of the distal radius fracture in the fracture database.
- Keywords
- Fracture Database, Fracture Classifications of the Distal Radius, Quality assurance, REDCap
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data analysis: Accuracy measurement of the classifications of the distal radius fracture in the fracture database.Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one time assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start9 Jun 2022
- Primary completionJun 2033 (estimated)
- Study completionJun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Murat Bilici, Principal investigator, University Hospital Basel, Clinic for Orthopedics and Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684042
- Sponsor's protocol ID
- 2022-00921; mu22Bilici
- Status last verified
- Dec 2024
- First submitted
- 4 Jan 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fracture Database of the University Hospital Basel: A REDCap Assisted Reliability and Validity Study of Fracture Classifications of the Distal Radius
- ClinicalTrials.gov ID
- NCT05684042
- Acronym / sponsor ID
- 2022-00921; mu22Bilici
- Conditions
- Distal Radius Fracture
- Keywords
- Fracture Database, Fracture Classifications of the Distal Radius, Quality assurance, REDCap
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- Jun 2033 (estimated)
- Study completion
- Jun 2033 (estimated)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
Number of discrepancies between the classifications of the expert group and the fracture database
Time frame: one time assessment at baseline
Number of discrepancies between the classifications of the expert group and the fracture database
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Murat Bilici principal investigator
University Hospital Basel, Clinic for Orthopedics and Traumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Radius Fracture, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Murat Bilici (+41 61 556 51 12, murat.bilici@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of discrepancies between the classifications of the expert group and the fracture database (time frame: one time assessment at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.