Smoking Cessation Study

Carbon Monoxide Breath Testing Prior to Total Joint Arthroplasty to Ascertain Smoking and Aid in Encouraging Smoking Cessation

The primary outcome of this study is to determine the true incidence of smokers among patients undergoing joint replacement and secondly, what percent are able to quit smoking before surgery under a structured cessation program with carbon monoxide breath testing. The investigators hypothesize that self-reported smoking status is underreported and that routine carbon monoxide breath testing will improve abstinence rates at the time of surgery.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation; Arthropathy
• Intervention / Treatment: Behavioral: Lifestyle Counseling

Detailed Description

This study looks at patients who have been referred to our clinic for a potential hip and knee joint replacement surgery. Once it has been determined that the patient requires surgical replacement of either their hip or knee and is placed on our surgical waitlist, the patient will be asked if he or she would like to participate in the study. The investigators would ask all patients, both self-declared smokers and non-smokers, to participate. This study would include completing a smoking history questionnaire and a noninvasive carbon monoxide breath test. While smoking status is already assessed in the McGill University Health Centre preoperative questionnaire, the investigators intend on expanding these questions in study participants to better quantify their nicotine exposure.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Adam Hart, MD; Phone Number: 43040 514-934-1934; Email: adam.hart@mgcill.ca
• Study Contact Backup: Name: Karen Smith, CRA; Phone Number: 43040 514-934-1934; Email: karen.smith@muhc.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3G 1A4
      • Recruiting
      • Dr, Adam Hart
      • Contact: Adam Hart, MD; Phone Number: 43040 514-934-1934; Email: adam.hart@mcgill.ca
      • Contact: Karen Smith; Phone Number: 43040 514-934-1934; Email: karen.smith@muhc.mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have been referred to our outpatient orthopaedic clinic for a potential hip and knee joint replacement and have been placed on our surgical waitlist for surgery.

Description

Inclusion Criteria:

• Adults ages 18-85 who require a primary total hip or knee replacement
• Any gender
• Smokers and non-smokers
• Osteoarthritis, rheumatoid arthritis, avascular necrosis

Exclusion Criteria:

• Patients who require revision surgery
• Previous fracture to affected area
• Emergency surgery
• Patients who do not understand, read or communicate in either French or English

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Smokers; All patients who participate in the study will complete the smoking history questionnaire and the carbon monoxide breath test. All patients with positive carbon monoxide breath test indicative of active nicotine exposure will be provided a structured smoking cessation program that includes information, counseling from their surgeon, or a trained health care professional and referral to a smoking cessation program.	Behavioral: Lifestyle Counseling; Referring to Stop smoking hotline, given pamphlets to encourage quitting smoking, pharmacy guidance, and possible referral to smoking cessation clinic.
Non-Smokers; Subjects who self-declared as non-smokers
Declared non-smokers with elevated Co2; subjects who self-declared as non-smokers but who tested positive for elevated Co2,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
True incidence of smokers among patients undergoing joint replacement	The percentage of subjects who declare themselves as smokers and non-smokers with elevated Co2 levels.	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the incidence of patients who successfully quit smoking prior to surgery.	The percentage of subjects who were able to quit smoking under a structured cessation program with Carbon monoxide breath testing.	20 minutes

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2021
• Primary Completion (Anticipated): January 31, 2025
• Study Completion (Anticipated): January 31, 2025

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 2020-6424

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No