Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2026-02-27 @ 5:32 AM
Study NCT ID:
NCT03768895
Status:
COMPLETED
Last Update Posted:
2019-02-19
First Post:
2018-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assement of the Morphological Characteristics of the Hips and Correlating Them With the Pathology Found
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-15', 'studyFirstSubmitDate': '2018-12-05', 'studyFirstSubmitQcDate': '2018-12-05', 'lastUpdatePostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ischiofemoral Space', 'timeFrame': '1 day', 'description': 'the smallest distance between the lateral cortex of the ischial tuberosity and medial cortex of the lesser trochanter.'}, {'measure': 'Quadratus Femoris Space', 'timeFrame': '1 day', 'description': 'the smallest space for passage of the quadratus femoris muscle delimited by the superolateral surface of the hamstring tendons and the posteromedial surface of the iliopsoas tendón or lesser trochanter.'}, {'measure': 'Cervicodiaphyseal angle', 'timeFrame': '1 day', 'description': 'The cervicodiaphyseal angle is formed by the axis of the femoral neck that joins the femoral head with the axis of the femoral shaft.'}, {'measure': 'Femoral version', 'timeFrame': '1 day', 'description': 'The femoral version or femoral torsion angle is called the projection on the transverse plane of a longitudinal axis of the femoral neck at the center of the femoral head'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Pain Chronic', 'Musculoskeletal Disease', 'Femoral Anteversion']}, 'descriptionModule': {'briefSummary': "The investigators' objective is the anatomical analysis of hips studied through MRI, assessing their morphological characteristics and correlating them with the pathology found.\n\nA retrospective search was performed using a database of consecutive reports of 137 adults pelvis MRI examinations obtained at MRI center in Zaragoza.\n\nIn all the images the investigators are going to measure the ischiofemoral space, quadratus femoris space, cervicodiaphysal angle and femoral version angle. The investigators evaluated different qualitative changes in the signal intensity of the quadratus femoris muscle as normal, edema, fatty infiltration or atrophy, and of the gluteus muscles as tendinopathy or atrophy, too.", 'detailedDescription': "The investigators' objective is the anatomical analysis of hips studied through MRI, assessing their morphological characteristics and correlating them with the pathology found.\n\nA retrospective search was performed using a database of consecutive reports of 137 adults pelvis MRI examinations obtained at MRI center in Zaragoza.\n\nThe investigators create a protocol for a retrospective review study, with the aim of analysis all the recorded MRI findings during this time. The criteria for patient inclusion were: Age \\> 18 years old, who had realised a pelvis MRI for any cause at MRI Center. Exclusion criteria included age \\< 18 years old, inadequate imaging quality, medical history likely to affect pelvic and hip morphometry: pelvic oncological disease, infection or inflammatory arthritis, postsurgical change disruptions, soft tissue abnormality, avascular necrosis, or pelvic and hip fracture.\n\nIn all the images the investigators are going to measure the ischiofemoral space, quadratus femoris space, cervicodiaphysal angle and femoral version angle. The investigators evaluated different qualitative changes in the signal intensity of the quadratus femoris muscle as normal, edema, fatty infiltration or atrophy, and of the gluteus muscles as tendinopathy or atrophy, too."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People who had realised a pelvis MRI for any cause at MRI Center in Zaragoza.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* Inadequate imaging quality\n* Medical history likely to affect pelvic and hip morphometry: pelvic oncological disease, infection or inflammatory arthritis, postsurgical change disruptions, soft tissue abnormality, avascular necrosis, or pelvic and hip fracture.'}, 'identificationModule': {'nctId': 'NCT03768895', 'briefTitle': 'Assement of the Morphological Characteristics of the Hips and Correlating Them With the Pathology Found', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Zaragoza'}, 'officialTitle': 'Assement of the Morphological Characteristics of the Hips and Correlating Them With the Pathology Found', 'orgStudyIdInfo': {'id': 'MRI center'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MRI group', 'description': 'The criteria for patient inclusion were: Age \\> 18 years old, who had realised a pelvis MRI for any cause at MRI Center. Exclusion criteria included age \\< 18 years old, inadequate imaging quality, medical history likely to affect pelvic and hip morphometry: pelvic oncological disease, infection or inflammatory arthritis, postsurgical change disruptions, soft tissue abnormality, avascular necrosis, or pelvic and hip fracture.', 'interventionNames': ['Radiation: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'RADIATION', 'description': 'The technique used was coronal and axial T1 and T2\\*WI sequences of the pelvis and femurs.\n\nThe MRI machine used is a HITACHI AIRIS-II1 model, with permanent vertical magnetic field of 0.3 Tesla, and the used sequences areT1, T2\\*WI.', 'armGroupLabels': ['MRI group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50006', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Dra. Roca Diagnóstico Médico. CEMEDI', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Zaragoza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maria Pilar López Royo', 'investigatorAffiliation': 'Universidad de Zaragoza'}}}}