Smoking Cessation Study

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05602753
• Other study ID #: 2020-6424
• Status: Recruiting
• Start date: February 18, 2021
• Est. completion date: January 31, 2025

Study information

• Verified date: November 2022
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Adam Hart, MD
• Phone: 514-934-1934
• Email: adam.hart[@]mgcill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy
• Joint Diseases
• Smoking Cessation

Intervention

Behavioral:
• Lifestyle Counseling
Referring to Stop smoking hotline, given pamphlets to encourage quitting smoking, pharmacy guidance, and possible referral to smoking cessation clinic.

Locations

Country	Name	City	State
Canada	Dr, Adam Hart	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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