Ignite Creation Date:
2025-12-26 @ 3:58 PM
Ignite Modification Date:
2025-12-26 @ 3:58 PM
Study NCT ID:
NCT04687306
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2020-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reliability of Sacral Slope, Pelvic Femoral Motion and Cup Ante-inclination on AP Pelvic Radiographs in Healthy Pts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-16', 'studyFirstSubmitDate': '2020-12-02', 'studyFirstSubmitQcDate': '2020-12-22', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraclass correlation coefficient (ICC) for Consistency in Spinopelvic Radiographic Measurements.', 'timeFrame': 'One year', 'description': 'The intraclass correlation coefficient (ICC) will be used to evaluate the consistency of the 4 providers in measuring the sacral slope, pelvic femoral angle and cup ante-inclination via radiographs in both sitting and standing positions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Currently, there are no validated anatomical landmarks that can be used to predict risk of and diagnose abnormal patterns of pelvic motion.This proposed study will measure sacral slope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions, using healthy individuals without a history of spinal and/or lower extremity pathology. All radiographs will be evaluated for the three measurements by four individuals with the intent of evaluating inter-observer reliability. Determining the reproducibility of these angles between observers will give insight into the potential clinical utility of these measurements in evaluating and treating patients with hip-spine syndrome.', 'detailedDescription': 'The purpose of this study is to evaluate the mechanics and influence of spinopelvic motion and balance from normal healthy subjects for the purpose of establishing radiographic measurements which are reliable and reproducible and which could give insight into the potential clinical utility of these measurements as future predictors of who may/may not have spinal pelvic issues and in evaluation and treatment of patients with hip-spine syndrome.\n\nThis specific objective of this study will be to measure sacral slope, pelvic femoral angle and cup ante-inclination via radiographs in both sitting and standing positions. The radiographs will be evaluated for the three measurements by four individuals with the intent of evaluating inter-observer reliability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy individuals, both male and females aged 25-50 without major co-morbidities and without spine/hip/pelvis issues including previous injuries or surgeries', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy individuals without major co-morbidities and without spine/hip/pelvis issues including previous injuries or surgeries\n\nExclusion Criteria:\n\n* no history of spine/hip/pelvis issues\n* females who are trying to get pregnant'}, 'identificationModule': {'nctId': 'NCT04687306', 'briefTitle': 'Reliability of Sacral Slope, Pelvic Femoral Motion and Cup Ante-inclination on AP Pelvic Radiographs in Healthy Pts', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Inter-observer Reliability of Sacral Slope, Pelvic Femoral Motion and Cup Ante-inclination on Anteroposterior Pelvic Radiographs in Healthy Individuals.', 'orgStudyIdInfo': {'id': '0719-20-FB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Females', 'description': '15 females', 'interventionNames': ['Diagnostic Test: X-rays- total of 4']}, {'label': 'Males', 'description': '15 Males', 'interventionNames': ['Diagnostic Test: X-rays- total of 4']}], 'interventions': [{'name': 'X-rays- total of 4', 'type': 'DIAGNOSTIC_TEST', 'description': 'X-rays of the sacral scope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions', 'armGroupLabels': ['Females', 'Males']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68918', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Kevin L Garvin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}