Reliability of Clinical Limb-length Measurements Methods

December 8, 2024 updated by: University of Pecs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Baranya
      • Pécs, Baranya, Hungary, 7632
        • Universtify of Pecs, Department of Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Young, healthy volunteers

Description

Inclusion Criteria:

  • Age: 18-30 years
  • BMI: < 30
  • Without orthopaedic complaint

Exclusion Criteria:

  • Previous surgery on lower limb or spine
  • Developmental disorder in the patients history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic test: EOS
EOS Micro Dose imaging will be done. SterEOS lower limb alignment reconstruction will be performed measuring the lim length.
Other Names:
  • EOS 2D/3D scanning and SterEOS 3D reconstruction
Diagnostic test: Clinical limb length measurements

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological limb length
Time Frame: 6 months
Limb length based on SterEOS 3D measurement
6 months
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.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Investigators

  • Study Chair: Adam T Schlegl, MD, PhD, University of Pecs Medical School, Department of Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

November 29, 2023

Study Registration Dates

First Submitted

November 4, 2021

First Submitted That Met QC Criteria

November 4, 2021

First Posted (Actual)

November 16, 2021

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 8, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UP-CC-Ortho-LimbLength

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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