Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT01807494
Status:
UNKNOWN
Last Update Posted:
2015-10-06
First Post:
2013-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Direct Anterior Versus Posterior Total Hip Arthroplasty Surgical Approaches
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010020', 'term': 'Osteonecrosis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-05', 'studyFirstSubmitDate': '2013-03-04', 'studyFirstSubmitQcDate': '2013-03-06', 'lastUpdatePostDateStruct': {'date': '2015-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to discontinued use of an assistive ambulatory device (cane or walker)', 'timeFrame': '6 week postoperative follow-up'}], 'secondaryOutcomes': [{'measure': 'modified Harris Hip Score', 'timeFrame': 'Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups'}, {'measure': 'SF-12', 'timeFrame': 'Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups'}, {'measure': 'Lower Extremity Functional Score', 'timeFrame': 'Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups'}, {'measure': 'Functional force testing', 'timeFrame': 'Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups', 'description': 'Testing to objectively quantify subject function when rising from a chair and descending stairs'}, {'measure': 'implant survivorship', 'timeFrame': '1-, 2-, 5-, 7-, and 10-year follow-ups'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Collected during the hospital stay (usually 1 to 5 days)'}, {'measure': 'Operative time', 'timeFrame': 'Intra-operative'}, {'measure': 'Number of patients that require blood transfusion', 'timeFrame': 'Intra-operative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis', 'Avascular Necrosis']}, 'descriptionModule': {'briefSummary': "Hip replacement is a common surgical procedure performed to relieve the pain and disability. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the hip with metal and plastic components shaped to allow continued motion of the hip. Surgeons may perform this operation in several different ways. The purpose of this study is to compare two different methods of performing total hip replacement. The investigators hypothesize that subjects treated with the anterior approached may show improved function during the early postoperative period, but that no differences in pain or function will be present after the first postoperative year.\n\nIn this study, patients that have elected to have hip replacement and consented to participate in the study will be randomized to have his or her hip replaced using one of two surgical techniques. Subjects will be randomized to be implanted using either an anterior or posterior approach. With the anterior approach, the study surgeon will use an incision that is on the front of the hip, and with the posterior approach, the incision will be more on the backside of your hip. The study surgeon has done more than 300 total hip replacements with both of these techniques.\n\nA baseline assessment will be conducted before hip replacement surgery that includes x-rays, functional tasks like getting up from a chair and stepping down a step, and three questionnaires about the hip, the subject's general health, and how well the subject is able to function. Also, subjects will be required to return to the clinic at several time points after surgery for follow-up visits. Follow-up visits will include hip assessments and questionnaires, as well as follow-up hip x-rays. The follow-up visits will be 6 weeks, 3 months, 1 year, 2 years, 5 years, 7 years, and 10 years after hip replacement surgery. These follow-up visits are part of the study surgeon's normal routine for hip replacement patients, and are not extra visits as a part of this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between ages of 18 and 85\n* End stage hip joint degeneration\n* Has elected to undergo primary total hip arthroplasty\n\nExclusion Criteria:\n\n* Undergoing revision arthroplasty\n* Inflammatory or rheumatoid arthritis\n* Patients with confounding medical conditions that are not expected to survive for the duration of follow-up (10 years)\n* Body Mass Index greater than 40 kg/m2\n* Age \\< 18 or \\> than 85\n* Previous ipsilateral hip surgery including arthroscopic procedures'}, 'identificationModule': {'nctId': 'NCT01807494', 'briefTitle': 'Direct Anterior Versus Posterior Total Hip Arthroplasty Surgical Approaches', 'organization': {'class': 'OTHER', 'fullName': 'New Lexington Clinic'}, 'officialTitle': 'Direct Anterior Versus Posterior Total Hip Arthroplasty Surgical Approaches', 'orgStudyIdInfo': {'id': 'LCO.2012.05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Posterior approach', 'description': 'Subjects in this group will total hip replacement performed with a posterior surgical approach and total hip replacement components.', 'interventionNames': ['Device: Total hip replacement components']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Anterior Approach', 'description': 'Subjects in this group will have total hip replacement performed with a direct anterior surgical approach and total hip replacement components.', 'interventionNames': ['Device: Total hip replacement components']}], 'interventions': [{'name': 'Total hip replacement components', 'type': 'DEVICE', 'otherNames': ['Femoral component will be the Biomet Taperloc Complete and the acetabular component will be the Biomet Ringloc+'], 'description': 'All patients will receive the same implants', 'armGroupLabels': ['Anterior Approach', 'Posterior approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40504', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Lexington Clinic', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Christian P Christensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lexington Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New Lexington Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biomet Orthopedics, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}