Reliability of Clinical Limb-length Measurements Methods

Leg Length Inequality Clinical Trial

Official title:

Reliability Study of the Clinical Limb-length Measurements Methods Applied in Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05122533
• Other study ID #: UP-CC-Ortho-LimbLength
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: November 2022
• Source: University of Pecs
• Contact: Peter Than, MD, PhD
• Phone: 003672536000
• Email: than.peter[@]pte.hu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 31, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Leg Length Inequality

Intervention

Diagnostic Test:
• EOS
EOS Micro Dose imaging will be done. SterEOS lower limb alignment reconstruction will be performed measuring the lim length.
• 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

Locations

Country	Name	City	State
Hungary	Daniel Kovacs	Pécs	Baranya

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological limb length	Limb length based on SterEOS 3D measurement	6 months
Primary	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.	6 months
Primary	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.	6 months