Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-03-05 @ 9:50 AM
Study NCT ID:
NCT02230657
Status:
COMPLETED
Last Update Posted:
2015-10-21
First Post:
2014-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'lastUpdateSubmitDate': '2015-10-20', 'studyFirstSubmitDate': '2014-08-29', 'studyFirstSubmitQcDate': '2014-08-29', 'lastUpdatePostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Satisfaction', 'timeFrame': 'Discharge through 30 days post-op'}]}, 'conditionsModule': {'conditions': ['Osteoarthritis of the Hip']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify differences in satisfaction, pain and length of stay between patients undergoing hip replacement who are discharged from the hospital on the day of surgery compared to patients who stay one night in the hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Primary THA without acute hip fracture or prior hardware that would need to be removed at the time of surgery\n* Unilateral THA\n* Pre-operative Body Mass Index (BMI) \\< 40 kg/m2\n* Age \\< 75 years at time of surgery\n* Pre-operative hemoglobin \\> 10 g/dL if pre-operative hemoglobin data is available\n* No history of cardiopulmonary disease that would necessitate inpatient monitoring after surgery\n* Pre-operative ambulatory status does not require the use of a walker or wheelchair\n* No chronic pre-operative opioid medication use or opioid addiction\n* Assistance available at home after discharge from hospital\n* No other condition or circumstance that would preclude rapid discharge from the hospital after surgery\n* Subject's English proficiency allows understanding of study and Informed Consent\n* Subject consented to participate in this study\n\nExclusion Criteria:\n\n* Revision THA\n* Bilateral THA\n* Pre-operative BMI ≥ 40 kg/m2\n* Age ≥ 75 at time of surgery\n* Pre-operative hemoglobin ≤ 10 g/dL if pre-operative hemoglobin data is available\n* History of cardiopulmonary disease requiring acute inpatient monitoring\n* Pre-operative ambulatory status requiring the use of a walker or wheelchair\n* Chronic pre-operative opioid medication use or opioid addiction\n* Limited or no assistance available at home after discharge from hospital\n* Any other condition or circumstance that would preclude rapid discharge from the hospital\n* Subject not proficient in English\n* Subject did not consent to participate in this study"}, 'identificationModule': {'nctId': 'NCT02230657', 'briefTitle': 'A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': 'A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach', 'orgStudyIdInfo': {'id': 'WHOZ01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Same day Discharge', 'interventionNames': ['Procedure: Same day discharge']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Next day discharge', 'interventionNames': ['Procedure: Next day discharge']}], 'interventions': [{'name': 'Same day discharge', 'type': 'PROCEDURE', 'armGroupLabels': ['Same day Discharge']}, {'name': 'Next day discharge', 'type': 'PROCEDURE', 'armGroupLabels': ['Next day discharge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '22306', 'city': 'Alexandria', 'state': 'Virginia', 'country': 'United States', 'facility': 'The Anderson Orthopaedic Clinic', 'geoPoint': {'lat': 38.80484, 'lon': -77.04692}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Anderson Orthopaedic Clinic', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}