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The Impact of Smoking on Outcomes and Complications in Total Joint Arthroplasty: A Prospective Crossover Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04592302
Recruitment Status : Enrolling by invitation
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Smoking Total Joint Arthroplasty Diagnostic Test: Blood Draw

Study Design
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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

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Groups and Cohorts
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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)
 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
 Diagnostic Test: Blood Draw
2-4 weeks before surgery a blood draw will be taken to test for nicotine levels in the body


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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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
Study Population
Patients who are current smokers having surgery for total joint arthroplasty at Rothman Orthopaedic Institute
Criteria

Inclusion criteria:

  1. Primary elective total joint arthroplasty patients undergoing surgery with a Rothman Institute arthroplasty surgeon.
  2. Participant is a current smoker.
  3. Diagnosis of osteoarthritis, inflammatory arthritis, and post-traumatic arthritis.

Exclusions criteria:

  1. Age < 18
  2. Revision surgery
  3. Prior infection in hip or knee at the surgical site
  4. 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.)
  5. 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.)
  6. Patients using chewing tobacco, cigars, or other form of oral tobacco product
  7. Patients using e-cigarettes or vaporizers
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No