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

• ClinicalTrials.gov Identifier: NCT00754299
• Recruitment Status: Withdrawn
• First Posted: September 17, 2008
• Last Update Posted: March 21, 2019
• Sponsor: Milton S. Hershey Medical Center
• Information provided by (Responsible Party): J. Spence Reid, Milton S. Hershey Medical Center

Tracking Information

• First Submitted Date: September 15, 2008
• First Posted Date: September 17, 2008
• Last Update Posted Date: March 21, 2019
• Study Start Date: October 2010
• Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 15, 2008): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: September 15, 2008): Absence of infection will be assessed by lab values, wound inspection, and radiographic evaluation where indicated. [ Time Frame: 24 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Smoking Cessation in Nonunion, Malunion, Osseous Infection
• Official Title: Outcome of a Prospective Protocol for Smoking Cessation in Nonunion, Malunion, Osseous Infection, and Infected Nonunion Patients

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.

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
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Fracture Nonunion
• Infection

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• Porter SE, Hanley EN Jr. The musculoskeletal effects of smoking. J Am Acad Orthop Surg. 2001 Jan-Feb;9(1):9-17. Review.
• Jorenby DE, Hays JT, Rigotti NA, Azoulay S, Watsky EJ, Williams KE, Billing CB, Gong J, Reeves KR; Varenicline Phase 3 Study Group. Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):56-63. Erratum in: JAMA. 2006 Sep 20;296(11):1355.
• Tobin ML. Why choose varenicline (chantix) for smoking cessation treatment? Issues Ment Health Nurs. 2007 Jun;28(6):663-7.
• Varenicline (CHANTIX): a stop-smoking pill. ORL Head Neck Nurs. 2006 Fall;24(4):18-9.
• Varenicline (Chantix) for tobacco dependence. Med Lett Drugs Ther. 2006 Aug 14-28;48(1241-1242):66-8.
• Gaston MS, Simpson AH. Inhibition of fracture healing. J Bone Joint Surg Br. 2007 Dec;89(12):1553-60. Review.

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: March 19, 2019): 0
• Original Estimated Enrollment (submitted: September 15, 2008): 60
• Estimated Study Completion Date: October 2012
• Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00754299
• Other Study ID Numbers: 28862
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: J. Spence Reid, Milton S. Hershey Medical Center
• Study Sponsor: Milton S. Hershey Medical Center
• Collaborators: Not Provided

Investigators

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

• PRS Account: Milton S. Hershey Medical Center
• Verification Date: March 2019