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

Recruiting

• Conditions: X-ray
• Interventions: Device: Radiographic assessment of the medial-distal tibial angle

• Registration Number: NCT05943236
• Lead Sponsor: Markus Knupp

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-05-10
• Study Start: 2023-06-01
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-04
• Last Update Submitted: 2023-07-04
• Study First Posted: 2023-07-13
• Last Update Posted: 2023-07-13
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients	Radiographic assessment of the medial-distal tibial angle	All patients

Primary Outcome Measures

Name	Time	Method
medial-distal tibial angle	Day 1 (There is only one single day of contact for each patient)	The angle is determined based on determining the mechanical axis and the angle axis.

Trial Locations

Locations (1)

Praxis "Meim Fusszentrum"; 🇨🇭 Basel, Switzerland