Smoking Cessation Study
Carbon Monoxide Breath Testing Prior to Total Joint Arthroplasty to Ascertain Smoking and Aid in Encouraging Smoking Cessation
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 18, 2021
CompletedFirst Submitted
Initial submission to the registry
October 27, 2022
CompletedFirst Posted
Study publicly available on registry
November 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2025
CompletedNovember 4, 2022
November 1, 2022
4 years
October 27, 2022
November 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To determine the incidence of patients who successfully quit smoking prior to surgery.
20 minutes
Study Arms (3)
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.
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,
Interventions
Referring to Stop smoking hotline, given pamphlets to encourage quitting smoking, pharmacy guidance, and possible referral to smoking cessation clinic.
Eligibility Criteria
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.
You may qualify if:
- Adults ages 18-85 who require a primary total hip or knee replacement
- Any gender
- Smokers and non-smokers
- Osteoarthritis, rheumatoid arthritis, avascular necrosis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr, Adam Hart
Montreal, Quebec, H3G 1A4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Staff Orthopaedic Surgeon
Study Record Dates
First Submitted
October 27, 2022
First Posted
November 2, 2022
Study Start
February 18, 2021
Primary Completion
January 31, 2025
Study Completion
January 31, 2025
Last Updated
November 4, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share