Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT04592302
Status:
UNKNOWN
Last Update Posted:
2020-10-19
First Post:
2020-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Smoking on Outcomes and Complications in Total Joint Arthroplasty: A Prospective Crossover Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-16', 'studyFirstSubmitDate': '2020-10-13', 'studyFirstSubmitQcDate': '2020-10-16', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound healing', 'timeFrame': '3 months', 'description': 'The primary objective of this study is to examine the impact of smoking cessation on total joint arthroplasty patients with respect to combined complications. For the purpose of the study combined complications will include: major in-hospital complications (MI, CVA, PE, pneumonia, return to the operating room, mortality), wound complications, readmission at 90 days, 90-day major complications (MI, CVA, PE, pneumonia, return to the operating room, mortality), and wound complications (prolonged hospitalization due to a wound issue, prolonged drainage \\> 7 days, superficial or deep SSI'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking', 'Total Joint Arthroplasty']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the impact of smoking cessation on total joint arthroplasty patients with respect to perioperative complications and outcomes. The investigators will examine patients who are asked to stop smoking in any manner they choose and also refrain from nicotine replacement therapy, and those who are allowed to continue smoking during the perioperative period for their total knee or total hip replacement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are current smokers having surgery for total joint arthroplasty at Rothman Orthopaedic Institute', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Primary elective total joint arthroplasty patients undergoing surgery with a Rothman Institute arthroplasty surgeon.\n2. Participant is a current smoker.\n3. Diagnosis of osteoarthritis, inflammatory arthritis, and post-traumatic arthritis.\n\nExclusions criteria:\n\n1. Age \\< 18\n2. Revision surgery\n3. Prior infection in hip or knee at the surgical site\n4. BMI \\>40 (It is currently the standard of care in our practice to require patients to have a BMI \\< 40 due to an increased risk of infection. This will not represent a change in practice.)\n5. Diabetics with Hgb A1C \\>8 (It is currently the standard of care in our practice to require patients to have a Hgb A1C \\<8 due to an increased risk of infection. This will not represent a change in practice.)\n6. Patients using chewing tobacco, cigars, or other form of oral tobacco product\n7. Patients using e-cigarettes or vaporizers'}, 'identificationModule': {'nctId': 'NCT04592302', 'briefTitle': 'The Impact of Smoking on Outcomes and Complications in Total Joint Arthroplasty: A Prospective Crossover Study', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': 'The Impact of Smoking on Outcomes and Complications in Total Joint Arthroplasty: A Prospective Crossover Study', 'orgStudyIdInfo': {'id': 'LAUS16D.265'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Smoking Cessation Group', 'description': 'participants are required to cease smoking for 4 weeks prior to and 2 weeks after TJA without any nicotine replacement (any other smoking cessation aids the patient chooses will be allowed)', 'interventionNames': ['Diagnostic Test: Blood Draw']}, {'label': 'Smoker Group 2', 'description': 'participants who are allowed to continue smoking and using nicotine in any form at their own discretion during the perioperative period', 'interventionNames': ['Diagnostic Test: Blood Draw']}], 'interventions': [{'name': 'Blood Draw', 'type': 'DIAGNOSTIC_TEST', 'description': '2-4 weeks before surgery a blood draw will be taken to test for nicotine levels in the body', 'armGroupLabels': ['Smoker Group 2', 'Smoking Cessation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Orthopaedic Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}