Smoking Cessation Study

Recruiting

• Conditions: Arthropathy; Smoking Cessation
• Interventions: Behavioral: Lifestyle Counseling

• Registration Number: NCT05602753
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

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.

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 Timeline

• Study Start: 2021-02-18
• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-10-27
• Status Verified: 2022-11
• Study First Posted: 2022-11-02
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-04
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Smokers	Lifestyle Counseling	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dr, Adam Hart; 🇨🇦 Montréal, Quebec, Canada