Reliability of Clinical Limb-length Measurements Methods

• Sponsor: University of Pecs (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05122533
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leg Length Inequality	Diagnostic Test: EOS; Diagnostic Test: Clinical limb length measurements

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Reliability Study of the Clinical Limb-length Measurements Methods Applied in Healthy Volunteers
• Actual Study Start Date: Oct 1, 2021
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm

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

Outcome Measures

Primary Outcome Measures

1. Radiological limb length [6 months]

   Limb length based on SterEOS 3D measurement

2. Intra- and interobserver reliability of the clinical lower limb measurements methods [6 months]

   Intra- and interobserver reliability of clinical length measuring methods will be calculated using the 3 separated measurement of the 3 observers.

3. Accuracy of the clinical lower limb measurements methods [6 months]

   Comparing the results of the radiological and clinical limb length results using the third measurement of the observers.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Daniel Kovacs	Pécs	Baranya	Hungary	7632

Sponsors and Collaborators

• University of Pecs

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pecs
• ClinicalTrials.gov Identifier: NCT05122533
• Other Study ID Numbers: UP-CC-Ortho-LimbLength
• First Posted: Nov 16, 2021
• Last Update Posted: Nov 16, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Pecs: leg length inequality; leg length discrepancy; EOS 2D/3D; physical examination; length measurement
• Additional relevant MeSH terms: Leg Length Inequality

Study Results

No Results Posted as of Nov 16, 2021