Reliability of Clinical Limb-length Measurements Methods

NCT05122533 | Completed

• 1 other identifier: UP-CC-Ortho-LimbLength
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leg Length Inequality

Keywords

leg length inequality; leg length discrepancy; EOS 2D/3D; physical examination; length measurement

Outcome Measures

Primary Outcomes (3)

• Radiological limb length

  Limb length based on SterEOS 3D measurement

  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.

  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.

  6 months

Study Arms (1)

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; Diagnostic Test: Clinical limb length measurements

Interventions

EOS DIAGNOSTIC_TEST

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

Also known as: EOS 2D/3D scanning and SterEOS 3D reconstruction

Study group

Clinical limb length measurements DIAGNOSTIC_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

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Young, healthy volunteers

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Universtify of Pecs, Department of Orthopaedics

Pécs, Baranya, 7632, Hungary

Location

MeSH Terms

Conditions

Leg Length Inequality

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Adam T Schlegl, MD, PhD

  University of Pecs Medical School, Department of Orthopaedics

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 16, 2021
• Study Start: October 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: November 29, 2023
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)