X-rayLAVIEWNCT05943236
Assessment of the Ankle Joint Axis Using a Long Ankle View Radiograph
An observational study of X-ray, run by Markus Knupp at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- X-ray
- What is being tested?
- Radiographic assessment of the medial-distal tibial angle
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2023to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical indication for a radiographic assessment of the lower half of one leg
Who may be able to join
- Clinical indication for a radiographic assessment of the lower half of one leg
- Age above 20
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Praxis "Meim Fusszentrum"
Basel, 4055
Markus Knupp, MD, 41 61 266 17 17, markus.knupp@meinfusszentrum.ch
Markus Knupp, MD
About this study
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.
Read the 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.
- Conditions
- X-ray
- Being tested
- Radiographic assessment of the medial-distal tibial angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| All patients | All patients Receives: Device: Radiographic assessment of the medial-distal tibial angle |
What is being measured
The primary outcome is the main question the study is designed to answer.
medial-distal tibial angle
The angle is determined based on determining the mechanical axis and the angle axis.
Measured: Day 1 (There is only one single day of contact for each patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Jun 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for X-rayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Markus Knupp
- Sponsor type
- University, hospital or other
- Collaborators
- Basel Academy for Quality and Research in Medicine, Merian Iselin Klinik
- Responsible party
- Sponsor-investigator, Markus Knupp, Mein Fusszentrum AG
- Investigators
- Markus Knupp, MD, Principal investigator, Praxis "Mein Fusszentrum"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943236
- Sponsor's protocol ID
- LAVIEW
- Acronym
- LAVIEW
- Status last verified
- Jul 2023
- First submitted
- 10 May 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be provided together with the publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Ankle Joint Axis Using a Long Ankle View Radiograph
- ClinicalTrials.gov ID
- NCT05943236
- Acronym / sponsor ID
- LAVIEW / LAVIEW
- Conditions
- X-ray
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Markus KnuppUniversity, hospital or other
- Collaborators
- Basel Academy for Quality and Research in Medicine, Merian Iselin Klinik
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Device: Radiographic assessment of the medial-distal tibial angleAll patients |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical indication for a radiographic assessment of the lower half of one leg
Key inclusion criteria (2 listed)
- Clinical indication for a radiographic assessment of the lower half of one leg
- Age above 20
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiographic assessment of the medial-distal tibial angleA long ankle view will be generated within a standard radiographic assessment and the medial-distal tibial angle will be assessed. | Device | All patients |
Primary outcome
medial-distal tibial angle
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: Yes. Data will be provided together with the publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Knupp, MD principal investigator
Praxis "Mein Fusszentrum"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of X-ray, run by Markus Knupp at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Markus Knupp, MD (+41 61 266 17 17, markus.knupp@meinfusszentrum.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
medial-distal tibial angle (time frame: Day 1 (There is only one single day of contact for each patient)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.