Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-06 @ 12:58 PM
Study NCT ID:
NCT06173557
Status:
COMPLETED
Last Update Posted:
2023-12-15
First Post:
2023-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Measurement Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2023-11-28', 'studyFirstSubmitQcDate': '2023-12-07', 'lastUpdatePostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'outcome', 'timeFrame': '1 year', 'description': 'calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['total hip replacement', 'limb length discrepancy'], 'conditions': ['Total Hip', 'Limb Length Discrepancy']}, 'descriptionModule': {'briefSummary': 'This retrospective cohort study included 50 consecutive patients who underwent THR. All surgeries were performed by the same orthopedic surgeon, using posterior approach. In all patients, the same technique of intraoperative measurement of the femoral offset and limb length was used, entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic imaging data and surgical reports.', 'detailedDescription': 'Introduction: Restoration of limb length equality and femoral offset is critical for the success of THR. The purpose of this study was to investigate the efficacy of a novel intraoperative measurement technique in minimizing errors in leg length and offset in total hip replacement (THR).\n\nMethods: This retrospective cohort study included 50 consecutive patients who underwent THR. All surgeries were performed by the same orthopedic surgeon, using posterior approach. In all patients, the same technique of intraoperative measurement of the femoral offset and limb length was used, entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic imaging data and surgical reports.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '50 consecutive patients who were admitted to the orthopedic department for elective THR', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\* patients that underwent THR due to primary osteoarthritis of the hip joint.\n\nExclusion Criteria:\n\n* Patients who underwent THR for any other reasons\n* patients that underwent revision surgery'}, 'identificationModule': {'nctId': 'NCT06173557', 'acronym': 'THR', 'briefTitle': 'Intraoperative Measurement Technique', 'organization': {'class': 'OTHER', 'fullName': 'Ziv Medical Center'}, 'officialTitle': 'Intraoperative Measurement Technique for Improved Accuracy of Femoral Offset and Leg Length in Total Hip Replacement: A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'ZivMC'}, 'secondaryIdInfos': [{'id': '0025-15-ziv', 'type': 'REGISTRY', 'domain': 'ZivMC'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic i', 'type': 'PROCEDURE', 'description': 'technique of intraoperative measurement of the femoral offset and limb length was used, entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic imaging data and surgical reports'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziv Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of orthopedic department', 'investigatorFullName': 'David Rothem', 'investigatorAffiliation': 'Ziv Medical Center'}}}}