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

NCT04592302 | Unknown

• 1 other identifier: LAUS16D.265
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Total Joint Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Wound healing

  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

  3 months

Study Arms (2)

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

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

Interventions

Blood Draw DIAGNOSTIC_TEST

2-4 weeks before surgery a blood draw will be taken to test for nicotine levels in the body

Smoker Group 2; Smoking Cessation Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are current smokers having surgery for total joint arthroplasty at Rothman Orthopaedic Institute

You may qualify if:

• 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.
• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 19, 2020
• Study Start: December 1, 2016
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

US (1)