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

NCT ID: NCT05943236

Last Updated: 2023-07-13

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

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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X-ray

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients

All patients

Radiographic assessment of the medial-distal tibial angle

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Basel Academy for Quality and Research in Medicine

UNKNOWN

Sponsor Role collaborator

Merian Iselin Klinik

OTHER

Sponsor Role collaborator

Markus Knupp

OTHER

Sponsor Role lead

Responsible Party

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Markus Knupp

Prof. Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Markus Knupp, MD

Role: PRINCIPAL_INVESTIGATOR

Praxis "Mein Fusszentrum"

Locations

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Praxis "Meim Fusszentrum"

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Markus Knupp, MD

Role: CONTACT

+41 61 266 17 17

Facility Contacts

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Markus Knupp, MD

Role: primary

41 61 266 17 17

Other Identifiers

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LAVIEW

Identifier Type: -

Identifier Source: org_study_id

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