Assessment of the Ankle Joint Axis Using a Long Ankle View Radiograph (LAVIEW)

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.

Study Overview

• Status: Recruiting
• Conditions: X-ray
• Intervention / Treatment: Device: Radiographic 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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Markus Knupp, MD; Phone Number: +41 61 266 17 17; Email: markus.knupp@meinfusszentrum.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4055
    • Recruiting
    • Praxis "Meim Fusszentrum"
    • Contact: Markus Knupp, MD; Phone Number: 41 61 266 17 17; Email: markus.knupp@meinfusszentrum.ch
    • Principal Investigator: Markus Knupp, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All patients	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Markus Knupp
• Collaborators: Merian Iselin Klinik; Basel Academy for Quality and Research in Medicine
• Investigators: Principal Investigator: Markus Knupp, MD, Praxis "Mein Fusszentrum"

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): September 30, 2023

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: LAVIEW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be provided together with the publication
• IPD Sharing Time Frame: Data will be made available at the date of publication for ever.
• IPD Sharing Access Criteria: There will be no criteria.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No