Assessment of the Ankle Joint Axis Using a Long Ankle Vie... | NCT05943236

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

NCT05943236

Sponsor

Markus Knupp

Status

Unknown status

Last Update Posted

Jul 13, 2023Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

X-ray

Interventions

Radiographic assessment of the medial-distal tibial angle

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Sep 30, 2023Estimated

Completion Date

Sep 30, 2023Estimated

First Submitted Date

May 10, 2023

First Submission Date that Met QC Criteria

Jul 4, 2023

First Posted Date

Jul 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2023

Last Update Posted Date

Jul 13, 2023Actual

Name	Class
Basel Academy for Quality and Research in Medicine	OTHER
Merian Iselin Klinik	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All patients		All patients	Device: Radiographic assessment of the medial-distal tibial angle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiographic assessment of the medial-distal tibial angle	Device	A long ankle view will be generated within a standard radiographic assessment and the medial-distal tibial angle will be assessed.

Outcomes Module

Primary Outcomes

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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Markus Knupp, MD	Contact	+41 61 266 17 17		markus.knupp@meinfusszentrum.ch

Overall Officials

Name	Affiliation	Role
Markus Knupp, MD	Praxis "Mein Fusszentrum"	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Praxis "Meim Fusszentrum"	Recruiting	Basel		4055	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data will be provided together with the publication

Types

Study Protocol

Time Frame

Data will be made available at the date of publication for ever.

Access Criteria

There will be no criteria.

URL

Not provided