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

Rothman Institute Orthopaedics

Status: Unknown

Conditions: Total Joint Arthroplasty; Smoking

Treatments: Diagnostic Test: Blood Draw

Study type: Observational

Funder types: Other

Identifiers

NCT04592302

LAUS16D.265

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,200 participants in 2 patient groups

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)

Treatment:

Diagnostic Test: Blood Draw

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

Treatment:

Diagnostic Test: Blood Draw