Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-02-19 @ 12:47 PM
Study NCT ID:
NCT02093832
Status:
COMPLETED
Last Update Posted:
2014-03-21
First Post:
2014-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does the Femoral Head Size Can Predict the Cup Size?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-19', 'studyFirstSubmitDate': '2014-03-11', 'studyFirstSubmitQcDate': '2014-03-19', 'lastUpdatePostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To examine the absolute difference between the planned cup size diameter and the actual femoral head size diameter', 'timeFrame': 'up to one year'}], 'primaryOutcomes': [{'measure': 'To evaluate the correlation between the planned preoperative cup size and the actual cup size that was implanted in surgery.', 'timeFrame': 'up to one year'}], 'secondaryOutcomes': [{'measure': 'To examine the absolute difference between the implanted cup size diameter and the actual femoral head size diameter.', 'timeFrame': 'up to one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['femoral head size', 'cup size', 'Total hip arthroplasty'], 'conditions': ['Total Hip Arthroplasty']}, 'descriptionModule': {'briefSummary': 'This study had four aims:\n\n1. To evaluate the correlation between the planned preoperative cup size and the actual cup size that was implanted in surgery.\n2. To examine the absolute difference between the implanted cup size diameter and the actual femoral head size diameter.\n3. To examine the absolute difference between the planned cup size diameter and the actual femoral head size diameter\n4. To suggest an additional online monitoring tool on the accuracy of the preoperative process and implant selection. We hypothesized that high accuracy rates will be found between the preoperative planned cup size and the actual implanted cup size. Furthermore, we hypothesized that strong correlations will be found between the planned and actual implanted cup size and the actual femoral head diameter size.', 'detailedDescription': "Methods This is a retrospective study , that will include patients who underwent primary cementless THA due to end-stage hip osteoarthritis during 2011 and 2013 . Inclusion criteria were: Patients that underwent primary THA due to end-stage primary osteoarthritis; Males and females between 15-90 years of age.\n\nData collection The following data will be collected: patients' characteristic including gender, age at surgery and side of surgery; implant information including cup model, planed cup size, actual cup size, shell type and outer diameter size (mm); actual femoral head diameter size (mm); the difference between the planned cup size and the actual cup size that was used; the difference between the actual femoral head diameter size measured at the end of surgery and the cementless implanted cup outer diameter size; the difference between the actual femoral head diameter size and the planed cup size.."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that underwent primary Total hip arthroplasty due to end-stage primary osteoarthritis; Males and females between 15-90 years of age.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that underwent primary Total hip arthroplasty due to end-stage primary osteoarthritis;\n\nExclusion Criteria:\n\n* Significant distortion in the femoral head.\n* Previous reconstructive surgery - radial osteotomy and hip socket.'}, 'identificationModule': {'nctId': 'NCT02093832', 'briefTitle': 'Does the Femoral Head Size Can Predict the Cup Size?', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'Does the Femoral Head Size Can Predict the Cup Size? Retrospective Study.', 'orgStudyIdInfo': {'id': '0067-13-EMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Total hip arthroplasty', 'interventionNames': ['Other: There are no specific Intervention']}], 'interventions': [{'name': 'There are no specific Intervention', 'type': 'OTHER', 'otherNames': ['are no specific Intervention'], 'description': 'are no specific Intervention', 'armGroupLabels': ['Total hip arthroplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18101', 'city': 'Afula', 'country': 'Israel', 'facility': 'HeEmek medical center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}, {'zip': '18101', 'city': 'Afula', 'country': 'Israel', 'facility': 'Orthopedic department, HaEmek medical center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}