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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

Tracking Information
First Submitted Date October 13, 2020
First Posted Date October 19, 2020
Last Update Posted Date October 19, 2020
Actual Study Start Date December 1, 2016
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 16, 2020)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Impact of Smoking on Outcomes and Complications in Total Joint Arthroplasty: A Prospective Crossover Study
Official Title The Impact of Smoking on Outcomes and Complications in Total Joint Arthroplasty: A Prospective Crossover Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who are current smokers having surgery for total joint arthroplasty at Rothman Orthopaedic Institute
Condition
  • Smoking
  • Total Joint Arthroplasty
Intervention Diagnostic Test: Blood Draw
2-4 weeks before surgery a blood draw will be taken to test for nicotine levels in the body
Study Groups/Cohorts
  • 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)
    Intervention: Diagnostic Test: Blood Draw
  • Smoker Group 2
    participants who are allowed to continue smoking and using nicotine in any form at their own discretion during the perioperative period
    Intervention: Diagnostic Test: Blood Draw
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: October 16, 2020)
1200
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04592302
Other Study ID Numbers LAUS16D.265
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Rothman Institute Orthopaedics
Original Responsible Party Same as current
Current Study Sponsor Rothman Institute Orthopaedics
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date October 2020