Assessment of the Ankle Joint Axis Using a Long Ankle View Radiograph

X-ray Clinical Trial

— LAVIEW  

Official title:

Assessment of the Ankle Joint Axis Using a Long Ankle View Radiograph

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05943236
• Other study ID #: LAVIEW
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: July 2023
• Source: Mein Fusszentrum AG
• Contact: Markus Knupp, MD
• Phone: +41 61 266 17 17
• Email: markus.knupp[@]meinfusszentrum.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study is a reliability (reproducibility) study on a single measurement procedure. Reliability (reproducibility) will be assessed by repeating the whole measurement procedure twice. The measurement procedure studied is the generation of a long ankle view image based on a radiographic assessment followed by a manual assessment of the medial-distal tibial angle.

Description:

The study is a reliability (reproducibility) study on a single measurement procedure. Reliability (reproducibility) will be assessed by repeating the whole measurement procedure twice. The measurement procedure studied is the generation of a long ankle view image based on a radiographic assessment followed by a manual assessment of the medial-distal tibial angle (MDTA).

In order to assess the value of different assessment methods of the MDTA, several variants will be considered, which are all applied to the same long ankle view image. To determine the intra- and interrater reliability of the manual assessment, this assessment will be done twice by different observers (one doctoral student, one radiologist) and repeated within each observer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion

• Clinical indication for a radiographic assessment of the lower half of one leg

• Age above 20

Exclusion Criteria:

• Previous bony procedures (surgery), fractures or anomalies of the lower leg, which does not allow a reliable assessment of the MDTA

• Symptomatic or clinically obvious malalignment at any level of the lower extremity

• Pregnancy

Related Conditions & MeSH terms

• X-ray

Intervention

Device:
• Radiographic assessment of the medial-distal tibial angle
A long ankle view will be generated within a standard radiographic assessment and the medial-distal tibial angle will be assessed.

Locations

Country	Name	City	State
Switzerland	Praxis "Meim Fusszentrum"	Basel

Sponsors (3)

Lead Sponsor	Collaborator
Markus Knupp	Basel Academy for Quality and Research in Medicine, Merian Iselin Klinik

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	medial-distal tibial angle	The angle is determined based on determining the mechanical axis and the angle axis.	Day 1 (There is only one single day of contact for each patient)