Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-30 @ 10:58 AM
Study NCT ID:
NCT06747494
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2024-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
General vs Spinal in Total Joint Arthroplasty (TJA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D000775', 'term': 'Anesthesia, Spinal'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2396}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2024-12-18', 'studyFirstSubmitQcDate': '2024-12-18', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'Up to 72 hours.', 'description': 'Will be measured in hours.'}, {'measure': 'Change in Patient Pain Scores as measured by the Numeric Rating Pain Scale', 'timeFrame': 'Baseline (up to 1 hour after surgery), up to 24 hours.', 'description': 'Score range from 0 to 10, higher score indicate higher pain scores.'}, {'measure': 'Change in Patient Nausea Scores as measured by the Conditioning Scoring Criteria', 'timeFrame': 'Baseline (up to 1 hour after surgery), up to 24 hours.', 'description': 'Score range from 0 to 9, higher score indicate higher nausea scores.'}, {'measure': 'Prosthetic joint infection', 'timeFrame': 'Up to 90 days.', 'description': 'Will be measured by the 2018 Musculoskeletal Infection Society criteria.'}, {'measure': 'Superficial surgical site infection', 'timeFrame': 'Up to 90 days.', 'description': 'Will be measured by the 2018 Musculoskeletal Infection Society criteria.'}, {'measure': 'Number of periprosthetic fracture', 'timeFrame': 'Up to 90 days.', 'description': 'Will be measured by the number of periprosthetic fracture.'}, {'measure': 'Number of implant dislocation.', 'timeFrame': 'Up to 90 days.', 'description': 'Will be measured by the number of implant dislocation.'}, {'measure': 'Number of participants who are readmitted 90 days after surgery.', 'timeFrame': 'Up to 90 days.', 'description': 'Will be measured by the number of participants who are readmitted 90 days after surgery.'}, {'measure': 'Number of participants who receive revision surgery 90 days after surgery.', 'timeFrame': 'Up to 90 days.', 'description': 'Will be measured by the number of participants who receive revision surgery 90 days after surgery.'}, {'measure': 'Number of participant deaths.', 'timeFrame': 'Up to 90 days.', 'description': 'Will be measured by the number of participants deaths.'}], 'secondaryOutcomes': [{'measure': 'Length of surgery.', 'timeFrame': 'Up to 2 hours.', 'description': 'Will be measured in hours.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total joint arthroplasty', 'General anesthesia', 'Spinal anesthesia'], 'conditions': ['Knee Osteoarthritis', 'Hip Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to compare post-operative outcomes from patients undergoing TJA. The study team wants to learn about outcomes like length of hospital stay, post-operative pain scores, post-operative nausea, deep and superficial surgical site infection, periprosthetic fracture (a broken bone that occurs around an orthopaedic implant), implant dislocation, readmission rates, and revision rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing a primary total hip or knee arthroplasty\n* Subjects must be capable of providing informed consent\n* English or Spanish speaking\n\nExclusion Criteria:\n\nPatients with contraindications for spinal anesthesia such as:\n\n* Prior lumbar surgery with hardware insertion\n* Elevated intracranial pressure\n* Infection at the site of the procedure\n* Thrombocytopenia or coagulopathy\n* Severe mitral and aortic stenosis and left ventricular outflow obstruction\n* Severe spine pathology (spinal stenosis, spondylolisthesis, spondylosis) with radiculopathy and/or neurogenic claudication\n* Preexisting neurological disease\n\nPatients with contraindications for general anesthesia such as:\n\n* Congestive heart failure\n* Severe aortic stenosis\n* Patient is unable/unwilling to consent\n* Current pregnancy or women planning on becoming pregnant in the next year, and women who think they might be pregnant, or women who become pregnant during the study period will be removed from the study.\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT06747494', 'briefTitle': 'General vs Spinal in Total Joint Arthroplasty (TJA)', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'General Versus Spinal Anesthesia for Total Joint Arthroplasty: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': '20240978'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'General Anesthesia', 'description': 'Participants in this group will receive general anesthesia for TJA for up to 2 hours.', 'interventionNames': ['Procedure: General Anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'Spinal Anesthesia', 'description': 'Participants in this group will receive spinal anesthesia for TJA for up to 2 hours.', 'interventionNames': ['Procedure: Spinal Anesthesia']}], 'interventions': [{'name': 'General Anesthesia', 'type': 'PROCEDURE', 'description': 'Participants will receive a one-time general anesthesia dose during the total joint arthroplasty procedure as per standard of care.', 'armGroupLabels': ['General Anesthesia']}, {'name': 'Spinal Anesthesia', 'type': 'PROCEDURE', 'description': 'Participants will receive a one-time spinal anesthesia dose during the total joint arthroplasty procedure as per standard of care.', 'armGroupLabels': ['Spinal Anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Victor H Hernandez, MD', 'role': 'CONTACT', 'email': 'vhh1@med.miami.edu', 'phone': '305-689-5195'}, {'name': 'Victor H Hernandez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Victor H Hernandez, MD', 'role': 'CONTACT', 'email': 'vhh1@med.miami.edu', 'phone': '305-689-5195'}, {'name': 'Antonio M Fernandez-Perez, MS', 'role': 'CONTACT', 'email': 'axf2089@miami.edu', 'phone': '305-689-5195'}], 'overallOfficials': [{'name': 'Victor H Hernandez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Clinical', 'investigatorFullName': 'Victor Hugo Hernandez', 'investigatorAffiliation': 'University of Miami'}}}}