Smoking Cessation in Nonunion, Malunion, Osseous Infection (nicotine)

March 19, 2019 updated by: J. Spence Reid, Milton S. Hershey Medical Center

Outcome of a Prospective Protocol for Smoking Cessation in Nonunion, Malunion, Osseous Infection, and Infected Nonunion Patients

The Study Investigators have seen high rates of tobacco cessation success combining Chantix with the risk of no surgery, should tobacco use continue. Once patients achieve tobacco cessation and undergo surgery, the investigators have seen high rates of union and/or infection resolution. The investigators are looking to document and publish these observations. To date, no studies have been published that have examined the effects of this type of protocol on short and long-term tobacco cessation.

The investigators want to examine and report the outcome of Hershey Medical Center's Orthopaedic Trauma Division's protocol for two endpoints: 1) pre-op tobacco cessation and 2) duration of tobacco cessation. This protocol involves counseling, Chantix, and a 'no-surgery' risk. Patients will be followed postoperatively for success and duration of tobacco cessation, as well as for fracture union and/or infection eradication.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

The Study Investigators have a Trauma subspecialty within Orthopaedic Surgery. We take care of numerous patients with ununited or malunited fractures i.e., nonunion/malunion patients, as well as patients with chronic bone infections, and patients with infected nonunions. The literature is replete with articles documenting the negative effects of nicotine on fracture healing and chronic bone infection resolution.(5) Many of our chronic infection and nonunion/malunion patients use nicotine in some form. Most of these patients need additional elective surgery to attain fracture union and/or infection resolution. Thus, we are faced with the dilemma of adding an additional procedure to a patient with proven risk factors for nonunion and continued infection. Much time is spent in clinic counseling patients about smoking cessation, requisite for a successful surgical outcome. Since nicotine is extremely addictive, our efforts at helping our trauma patients relinquish tobacco are not always successful. Many of our patients need pharmacologic help with the goal of cessation, and we have been providing Chantix prescriptions to them. In addition to providing Chantix, we currently present to our patients, as standard of care, a requirement that smoking cessation is necessary prior to performing additional surgical procedures.

Chantix (generic name, varenicline)is a relatively new drug designed for helping with tobacco cessation. It has shown great promise for success since it both decreases cravings for nicotine (the highly addictive active ingredient in tobacco) and diminishes withdrawal symptoms of nicotine. This novel, dual approach works by binding to nicotinic receptors in the brain as a partial agonist, decreasing the pleasurable effects of cigarettes and other tobacco products. Once bound to these receptors, Chantix blocks actual nicotine. While blocking nicotine receptors, it also acts like a weak substitute for nicotine, decreasing symptoms of withdrawal. (2)

Our study will include 60 tobacco-using patients of all ages above 18 with osseous nonunion, malunion, established bone infection, or combined diagnoses.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - The Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Our study will include 60 tobacco-using patients of all ages above 18 with osseous nonunion, malunion, established bone infection, or combined diagnoses.

Description

Inclusion Criteria:

Participants must be a tobacco user and have an osseous nonunion, malunion, infection, or infected nonunion of the Clavicle, Humerus, Radius, Ulna, Pelvis, Femur, Tibia, Fibula, or Calcaneus.
Subjects must be above age 18, be able to understand and give consent, and be non-pregnant.

Exclusion Criteria:

Patients unable to understand the protocol, patients allergic to chantix, prisoners, and pregnant patients will be excluded, and patients with pre-existing psychiatric illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Union will be defined as no or minimal pain at the fracture site with direct palpation and weight-bearing when applicable; and radiographically, as a minimum of 3 bridging cortices across the fracture site in anteroposterior, lateral, oblique views. Time Frame: 24 months	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Absence of infection will be assessed by lab values, wound inspection, and radiographic evaluation where indicated. Time Frame: 24 months	24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

Principal Investigator: Spence Reid, MD, Penn State Milton S. Hershey Medica Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)