NCT05943236

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

May 10, 2023

Last Update Submit

July 4, 2023

Conditions

X-ray

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

All patients

All patients

Device: Radiographic assessment of the medial-distal tibial angle

Interventions

Radiographic assessment of the medial-distal tibial angleDEVICE

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

All patients

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Clinical indication for a radiographic assessment of the lower half of one leg
  • Age above 20

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Praxis "Meim Fusszentrum"

Basel, 4055, Switzerland

RECRUITING

Study Officials

  • Markus Knupp, MD

    Praxis "Mein Fusszentrum"

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Markus Knupp, MD

CONTACT

+41 61 266 17 17markus.knupp@meinfusszentrum.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

May 10, 2023

First Posted

July 13, 2023

Study Start

June 1, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Data will be provided together with the publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be made available at the date of publication for ever.
Access Criteria
There will be no criteria.

Locations

CH(1)