Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-30 @ 1:45 PM
Study NCT ID:
NCT01621932
Status:
COMPLETED
Last Update Posted:
2021-01-26
First Post:
2012-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterior Capsulectomy vs. Repair in Direct Anterior THA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2012-06-14', 'studyFirstSubmitQcDate': '2012-06-14', 'lastUpdatePostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hip flexion', 'timeFrame': 'postoperative 4 months'}], 'secondaryOutcomes': [{'measure': 'Visual analog scale-pain', 'timeFrame': '4 months and 12 months post operative'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anterior approach'], 'conditions': ['Total Hip Arthroplasty']}, 'descriptionModule': {'briefSummary': 'Randomized prospective study comparing the anterior capsule repair vs capsulectomy with regards to post-operative pain and range of motion outcomes in elective primary unilateral direct anterior approach THA for osteoarthritis. Visual Analog Scores (VAS) will be recorded for preoperative and postoperative months 1 and 4. Hip range of motion will be assessed by goniometer measurements and lateral hip radiographs in maximum flexion.\n\nThe purpose of the study is to compare post-operative pain control and hip range of motion between two surgical techniques (anterior capsular repair vs. anterior capsulectomy) during direct anterior total hip arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective unilateral primary total hip arthroplasty Direct anterior surgical approach Osteoarthritis diagnosis 18 years of age or older\n\nExclusion Criteria:\n\n* Bilateral primary total hip arthroplasty Revision hip arthroplasty Avascular necrosis of the hip Rheumatoid arthritis of the hip Younger than 18 years of age'}, 'identificationModule': {'nctId': 'NCT01621932', 'briefTitle': 'Anterior Capsulectomy vs. Repair in Direct Anterior THA', 'organization': {'class': 'OTHER', 'fullName': 'OrthoCarolina Research Institute, Inc.'}, 'officialTitle': 'Anterior Capsulectomy vs. Repair in Direct Anterior THA', 'orgStudyIdInfo': {'id': '101105A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical approach 1', 'description': 'Direct anterior surgical approach with capsulectomy', 'interventionNames': ['Procedure: Direct anterior approach with capsulectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical approach 2', 'description': 'Direct anterior approach without capsulectomy', 'interventionNames': ['Procedure: Direct anterior approach without capsulectomy']}], 'interventions': [{'name': 'Direct anterior approach with capsulectomy', 'type': 'PROCEDURE', 'description': 'Direct anterior approach with capsulectomy', 'armGroupLabels': ['Surgical approach 1']}, {'name': 'Direct anterior approach without capsulectomy', 'type': 'PROCEDURE', 'description': 'Direct anterior approach without capsulectomy', 'armGroupLabels': ['Surgical approach 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OrthoCarolina, P.A.', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'John Masonis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OrthoCarolina, P.A.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OrthoCarolina Research Institute, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}