Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-01-01 @ 5:28 AM
Study NCT ID:
NCT05122533
Status:
COMPLETED
Last Update Posted:
2024-12-12
First Post:
2021-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability of Clinical Limb-length Measurements Methods
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007870', 'term': 'Leg Length Inequality'}], 'ancestors': [{'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-08', 'studyFirstSubmitDate': '2021-11-04', 'studyFirstSubmitQcDate': '2021-11-04', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiological limb length', 'timeFrame': '6 months', 'description': 'Limb length based on SterEOS 3D measurement'}, {'measure': 'Intra- and interobserver reliability of the clinical lower limb measurements methods', 'timeFrame': '6 months', 'description': 'Intra- and interobserver reliability of clinical length measuring methods will be calculated using the 3 separated measurement of the 3 observers.'}, {'measure': 'Accuracy of the clinical lower limb measurements methods', 'timeFrame': '6 months', 'description': 'Comparing the results of the radiological and clinical limb length results using the third measurement of the observers.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['leg length inequality', 'leg length discrepancy', 'EOS 2D/3D', 'physical examination', 'length measurement'], 'conditions': ['Leg Length Inequality']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Young, healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-30 years\n* BMI: \\< 30\n* Without orthopaedic complaint\n\nExclusion Criteria:\n\n* Previous surgery on lower limb or spine\n* Developmental disorder in the patients history'}, 'identificationModule': {'nctId': 'NCT05122533', 'briefTitle': 'Reliability of Clinical Limb-length Measurements Methods', 'organization': {'class': 'OTHER', 'fullName': 'University of Pecs'}, 'officialTitle': 'Reliability Study of the Clinical Limb-length Measurements Methods Applied in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'UP-CC-Ortho-LimbLength'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': '18-30 year-old, healthy volunteers\n\n* Age: 18-30 years\n* BMI: \\<30\n* No previous surgery on lower limb or spine\n* No known developmental disorder\n* Without any orthopaedic complaint', 'interventionNames': ['Diagnostic Test: EOS', 'Diagnostic Test: Clinical limb length measurements']}], 'interventions': [{'name': 'EOS', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['EOS 2D/3D scanning and SterEOS 3D reconstruction'], 'description': 'EOS Micro Dose imaging will be done. SterEOS lower limb alignment reconstruction will be performed measuring the lim length.', 'armGroupLabels': ['Study group']}, {'name': 'Clinical limb length measurements', 'type': 'DIAGNOSTIC_TEST', 'description': "Clinical measurement of both lower limbs' length, 3 times in 3 different days by 3 observers.\n\n* bony markers position (heel contour, patella and medial malleolus) in resupinate and side position also\n* tape measuring:\n\n * Spina iliaca anterior superior - medial malleolus\n * umbilicus - medial malleolus\n * greater trochanter - lateral malleolus\n * in standing, sitting, resupinate and side position", 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7632', 'city': 'Pécs', 'state': 'Baranya', 'country': 'Hungary', 'facility': 'Universtify of Pecs, Department of Orthopaedics', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}], 'overallOfficials': [{'name': 'Adam T Schlegl, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pecs Medical School, Department of Orthopaedics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pecs', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}