Leg Length InequalityNCT05122533
Reliability of Clinical Limb-length Measurements Methods
An observational study of Leg Length Inequality, run by University of Pecs at 1 site in Hungary.
Trial summary
There are numerous ways to measure limb length discrepancy in the clinical practice, although their reliability and accuracy are not well known. In our prospective diagnostic study we aimed to test the most popular methods and compare their results to EOS 3D reconstructions data. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Leg Length Inequality
- What is being tested?
- EOS and Clinical limb length measurements
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 1 Oct 2021to 29 Nov 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young, healthy volunteers
Who may be able to join
- Age: 18-30 years
- BMI: < 30
- Without orthopaedic complaint
Who cannot join
- Previous surgery on lower limb or spine
- Developmental disorder in the patients history
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Universtify of Pecs, Department of Orthopaedics
Pécs, Baranya, 7632
About this study
Official title: Reliability Study of the Clinical Limb-length Measurements Methods Applied in Healthy Volunteers
There are numerous ways to measure limb length discrepancy in the clinical practice, although their reliability and accuracy are not well known. In our prospective diagnostic study we aimed to test the most popular methods and compare their results to EOS 3D reconstructions data.
- Conditions
- Leg Length Inequality
- Being tested
- EOS, Clinical limb length measurements
- Keywords
- leg length inequality, leg length discrepancy, EOS 2D/3D, physical examination, length measurement
- Medical subject headings
- Leg Length Inequality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOSDiagnostic test
Also called EOS 2D/3D scanning and SterEOS 3D reconstruction
EOS Micro Dose imaging will be done. SterEOS lower limb alignment reconstruction will be performed measuring the lim length.
Clinical limb length measurementsDiagnostic test
Clinical measurement of both lower limbs' length, 3 times in 3 different days by 3 observers.
- bony markers position (heel contour, patella and medial malleolus) in resupinate and side position also
- tape measuring:
- Spina iliaca anterior superior - medial malleolus
- umbilicus - medial malleolus
- greater trochanter - lateral malleolus
- in standing, sitting, resupinate and side position
| Study group | Role | What they receive |
|---|---|---|
| Study group | 18-30 year-old, healthy volunteers
* Age: 18-30 years
* BMI: <30
* No previous surgery on lower limb or spine
* No known developmental disorder
* Without any orthopaedic complaint Receives: Diagnostic Test: EOS; Diagnostic Test: Clinical limb length measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological limb length
Limb length based on SterEOS 3D measurement
Measured: 6 months
Intra- and interobserver reliability of the clinical lower limb measurements methods
Intra- and interobserver reliability of clinical length measuring methods will be calculated using the 3 separated measurement of the 3 observers.
Measured: 6 months
Accuracy of the clinical lower limb measurements methods
Comparing the results of the radiological and clinical limb length results using the third measurement of the observers.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start1 Oct 2021
- Primary completion30 Jun 2022
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg Length InequalityStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam T Schlegl, MD, PhD, Study chair, University of Pecs Medical School, Department of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122533
- Sponsor's protocol ID
- UP-CC-Ortho-LimbLength
- Status last verified
- Dec 2024
- First submitted
- 4 Nov 2021
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability Study of the Clinical Limb-length Measurements Methods Applied in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05122533
- Acronym / sponsor ID
- UP-CC-Ortho-LimbLength
- Conditions
- Leg Length Inequality
- Keywords
- leg length inequality, leg length discrepancy, EOS 2D/3D, physical examination, length measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 16 Nov 2021 (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.
There are numerous ways to measure limb length discrepancy in the clinical practice, although their reliability and accuracy are not well known. In our prospective diagnostic study we aimed to test the most popular methods and compare their results to EOS 3D reconstructions data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: EOS, Diagnostic Test: Clinical limb length measurements18-30 year-old, healthy volunteers * Age: 18-30 years * BMI: <30 * No previous surgery on lower limb or spine * No known developmental disorder * Without any orthopaedic complaint |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young, healthy volunteers
Key inclusion criteria (3 listed)
- Age: 18-30 years
- BMI: < 30
- Without orthopaedic complaint
Key exclusion criteria (2 listed)
- Previous surgery on lower limb or spine
- Developmental disorder in the patients history
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 |
|---|---|---|
| EOSAlso: EOS 2D/3D scanning and SterEOS 3D reconstructionEOS Micro Dose imaging will be done. SterEOS lower limb alignment reconstruction will be performed measuring the lim length. | Diagnostic test | Study group |
| Clinical limb length measurementsClinical measurement of both lower limbs' length, 3 times in 3 different days by 3 observers. * bony markers position (heel contour, patella and medial malleolus) in resupinate and side position also * tape measuring: * Spina iliaca anterior superior - medial malleolus * umbilicus - medial malleolus * greater trochanter - lateral malleolus * in standing, sitting, resupinate and side position | Diagnostic test | Study group |
Primary outcome
Radiological limb length
Time frame: 6 months
Limb length based on SterEOS 3D measurement
Intra- and interobserver reliability of the clinical lower limb measurements methods
Time frame: 6 months
Intra- and interobserver reliability of clinical length measuring methods will be calculated using the 3 separated measurement of the 3 observers.
Accuracy of the clinical lower limb measurements methods
Time frame: 6 months
Comparing the results of the radiological and clinical limb length results using the third measurement of the observers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Leg Length Inequality
Not yet recruiting
Acute Effect of Standardized Ankle Taping on Lower Limb Asymmetry During Countermovement Jump in Healthy Judokas
Ankle Stability
RecruitingObservational study
Analysis of the Biomechanical Impact of Lower Limb Length Inequality in PEDiatrics
Lower Limb Length Discrepancy (LLD) in Children
RecruitingObservational study
Study to Assess the Pain, Satisfaction, and Quality of Life of Patients With FITBONE® Lengthening Nail
Leg Length Inequality
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.
Adam T Schlegl, MD, PhD study chair
University of Pecs Medical School, Department of Orthopaedics
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 Leg Length Inequality, run by University of Pecs at 1 site in Hungary.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 12 Dec 2024. 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 Hungary. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological limb length (time frame: 6 months). The study lists 3 primary outcomes in all. 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 12 Dec 2024.