COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00754299
Recruitment Status : Withdrawn (Study could not get funding; research never initiated.)
First Posted : September 17, 2008
Last Update Posted : March 21, 2019
Information provided by (Responsible Party):
J. Spence Reid, Milton S. Hershey Medical Center

Brief Summary:

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

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00754299

Layout table for location information
United States, Pennsylvania
The Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Layout table for investigator information
Principal Investigator: Spence Reid, MD Penn State Milton S. Hershey Medica Center
Layout table for additonal information
Responsible Party: J. Spence Reid, Principal Investigator, Milton S. Hershey Medical Center Identifier: NCT00754299    
Other Study ID Numbers: 28862
First Posted: September 17, 2008    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Keywords provided by J. Spence Reid, Milton S. Hershey Medical Center:
nonunion/malunion osseous fractures
nicotine dependent
chronic osseous infection
infected osseous nonunions
Fracture nonunion or infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Fractures, Ununited
Fractures, Bone
Wounds and Injuries