NCT00754299

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2008

Completed
2 years until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

September 15, 2008

Last Update Submit

March 19, 2019

Conditions

Fracture NonunionInfection

Keywords

nonunion/malunion osseous fracturesnicotine dependentchronic osseous infectioninfected osseous nonunionsFracture nonunion or infection

Outcome Measures

Primary Outcomes (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.

    24 months

Secondary Outcomes (1)

  • Absence of infection will be assessed by lab values, wound inspection, and radiographic evaluation where indicated.

    24 months

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (6)

  • Porter SE, Hanley EN Jr. The musculoskeletal effects of smoking. J Am Acad Orthop Surg. 2001 Jan-Feb;9(1):9-17. doi: 10.5435/00124635-200101000-00002.

    PMID: 11174159BACKGROUND

  • 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. doi: 10.1001/jama.296.1.56.

    PMID: 16820547BACKGROUND

  • Tobin ML. Why choose varenicline (chantix) for smoking cessation treatment? Issues Ment Health Nurs. 2007 Jun;28(6):663-7. doi: 10.1080/01612840701354661. No abstract available.

    PMID: 17613164BACKGROUND

  • Varenicline (CHANTIX): a stop-smoking pill. ORL Head Neck Nurs. 2006 Fall;24(4):18-9.

    PMID: 17390707BACKGROUND

  • Varenicline (Chantix) for tobacco dependence. Med Lett Drugs Ther. 2006 Aug 14-28;48(1241-1242):66-8. No abstract available.

    PMID: 16977281BACKGROUND

  • Gaston MS, Simpson AH. Inhibition of fracture healing. J Bone Joint Surg Br. 2007 Dec;89(12):1553-60. doi: 10.1302/0301-620X.89B12.19671.

    PMID: 18057352BACKGROUND

MeSH Terms

Conditions

Fractures, UnunitedInfections

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Officials

  • Spence Reid, MD

    Penn State Milton S. Hershey Medica Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2008

First Posted

September 17, 2008

Study Start

October 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

March 21, 2019

Record last verified: 2019-03

Locations

US(1)