Smoking Cessation in Nonunion, Malunion, Osseous Infection (nicotine)
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|ClinicalTrials.gov Identifier: NCT00754299|
Recruitment Status : Withdrawn (Study could not get funding; research never initiated.)
First Posted : September 17, 2008
Last Update Posted : August 8, 2011
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.
|Condition or disease|
|Fracture Nonunion Infection|
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|
|Estimated Enrollment :||60 participants|
|Official Title:||Outcome of a Prospective Protocol for Smoking Cessation in Nonunion, Malunion, Osseous Infection, and Infected Nonunion Patients|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||October 2012|
- 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 ]
- Absence of infection will be assessed by lab values, wound inspection, and radiographic evaluation where indicated. [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754299
|United States, Pennsylvania|
|The Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Spence Reid, MD||Penn State Milton S. Hershey Medica Center|