Smoking Cessation Study

NCT ID: NCT05602753

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-18

Study Completion Date

2025-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation Arthropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Lifestyle Counseling

Intervention Type BEHAVIORAL

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

No interventions assigned to this group

Declared non-smokers with elevated Co2

subjects who self-declared as non-smokers but who tested positive for elevated Co2,

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lifestyle Counseling

Referring to Stop smoking hotline, given pamphlets to encourage quitting smoking, pharmacy guidance, and possible referral to smoking cessation clinic.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Adam Hart

Principal Investigator, Staff Orthopaedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dr, Adam Hart

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Adam Hart, MD

Role: CONTACT

514-934-1934 ext. 43040

Karen Smith, CRA

Role: CONTACT

514-934-1934 ext. 43040

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Adam Hart, MD

Role: primary

514-934-1934 ext. 43040

Karen Smith

Role: backup

514-934-1934 ext. 43040

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-6424

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Connect to Quit for Smoking
NCT01299896 COMPLETED NA
Smoking Cessation in Hospitalized Smokers
NCT01289275 COMPLETED PHASE4
Smoking Cessation Intervention for Cancer Patients
NCT00575718 ACTIVE_NOT_RECRUITING NA