Smoking CessationNCT05602753
Smoking Cessation Study
An observational study of Smoking Cessation and Arthropathy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Smoking Cessation, Arthropathy
- What is being tested?
- Lifestyle Counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 18 Feb 2021to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults ages 18-85 who require a primary total hip or knee replacement
- Any gender
- Smokers and non-smokers
- Osteoarthritis, rheumatoid arthritis, avascular necrosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Dr, Adam Hart
Montreal, Quebec, H3G 1A4
Adam Hart, MD, 514-934-1934 ext. 43040, adam.hart@mcgill.ca
Karen Smith, 514-934-1934 ext. 43040, karen.smith@muhc.mcgill.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation, Arthropathy
- Being tested
- Lifestyle Counseling
- Medical subject headings
- Smoking Cessation, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle CounselingBehavioural
Referring to Stop smoking hotline, given pamphlets to encourage quitting smoking, pharmacy guidance, and possible referral to smoking cessation clinic.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Lifestyle Counseling | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes
Secondary outcomes (1)
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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start18 Feb 2021
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Hart, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602753
- Sponsor's protocol ID
- 2020-6424
- Status last verified
- Nov 2022
- First submitted
- 27 Oct 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon Monoxide Breath Testing Prior to Total Joint Arthroplasty to Ascertain Smoking and Aid in Encouraging Smoking Cessation
- ClinicalTrials.gov ID
- NCT05602753
- Acronym / sponsor ID
- 2020-6424
- Conditions
- Smoking Cessation, Arthropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smokers | – | Behavioral: Lifestyle CounselingAll 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, |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Adults ages 18-85 who require a primary total hip or knee replacement
- Any gender
- Smokers and non-smokers
- Osteoarthritis, rheumatoid arthritis, avascular necrosis
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle CounselingReferring to Stop smoking hotline, given pamphlets to encourage quitting smoking, pharmacy guidance, and possible referral to smoking cessation clinic. | Behavioural | Smokers |
Primary outcome
True incidence of smokers among patients undergoing joint replacement
Time frame: 15 minutes
The percentage of subjects who declare themselves as smokers and non-smokers with elevated Co2 levels.
1 secondary outcome
To determine the incidence of patients who successfully quit smoking prior to surgery.
Time frame: 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation and Arthropathy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam Hart, MD (514-934-1934 ext. 43040, adam.hart@mgcill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
True incidence of smokers among patients undergoing joint replacement (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.