The Impact of Smoking on Outcomes and Complications in Total Joint Arthroplasty: A Prospective Crossover Study
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ClinicalTrials.gov Identifier: NCT04592302 |
Recruitment Status :
Enrolling by invitation
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
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Condition or disease | Intervention/treatment |
---|---|
Smoking Total Joint Arthroplasty | Diagnostic Test: Blood Draw |
Study Type : | Observational |
Estimated Enrollment : | 1200 participants |
Observational Model: | Case-Crossover |
Time Perspective: | Prospective |
Official Title: | The Impact of Smoking on Outcomes and Complications in Total Joint Arthroplasty: A Prospective Crossover Study |
Actual Study Start Date : | December 1, 2016 |
Estimated Primary Completion Date : | July 31, 2021 |
Estimated Study Completion Date : | July 31, 2021 |

Group/Cohort | Intervention/treatment |
---|---|
Smoking Cessation Group
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)
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Diagnostic Test: Blood Draw
2-4 weeks before surgery a blood draw will be taken to test for nicotine levels in the body |
Smoker Group 2
participants who are allowed to continue smoking and using nicotine in any form at their own discretion during the perioperative period
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Diagnostic Test: Blood Draw
2-4 weeks before surgery a blood draw will be taken to test for nicotine levels in the body |
- Wound healing [ Time Frame: 3 months ]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

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion criteria:
- Primary elective total joint arthroplasty patients undergoing surgery with a Rothman Institute arthroplasty surgeon.
- Participant is a current smoker.
- Diagnosis of osteoarthritis, inflammatory arthritis, and post-traumatic arthritis.
Exclusions criteria:
- Age < 18
- Revision surgery
- Prior infection in hip or knee at the surgical site
- 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.)
- 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.)
- Patients using chewing tobacco, cigars, or other form of oral tobacco product
- Patients using e-cigarettes or vaporizers

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04592302
United States, Pennsylvania | |
Rothman Orthopaedic Institute | |
Philadelphia, Pennsylvania, United States, 19107 |
Responsible Party: | Rothman Institute Orthopaedics |
ClinicalTrials.gov Identifier: | NCT04592302 |
Other Study ID Numbers: |
LAUS16D.265 |
First Posted: | October 19, 2020 Key Record Dates |
Last Update Posted: | October 19, 2020 |
Last Verified: | October 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |