Fracture NonunionnicotineNCT00754299
Smoking Cessation in Nonunion, Malunion, Osseous Infection
An observational study of Fracture Nonunion and Infection, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Fracture Nonunion, Infection
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients unable to understand the protocol, patients allergic to chantix, prisoners, and pregnant patients will be excluded, and patients with pre-existing psychiatric illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: 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.
Read the 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.
- Conditions
- Fracture Nonunion, Infection
- Keywords
- nonunion/malunion osseous fractures, nicotine dependent, chronic osseous infection, infected osseous nonunions, Fracture nonunion or infection
- Medical subject headings
- Fractures, Ununited, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
Absence of infection will be assessed by lab values, wound inspection, and radiographic evaluation where indicated.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2008 (estimated)
- Study startOct 2010
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Why it stopped: Study could not get funding; research never initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Fracture NonunionStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Spence Reid, Milton S. Hershey Medical Center
- Investigators
- Spence Reid, MD, Principal investigator, Penn State Milton S. Hershey Medica Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754299
- Sponsor's protocol ID
- 28862
- Acronym
- nicotine
- Status last verified
- Mar 2019
- First submitted
- 15 Sep 2008
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11174159Jorenby 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.
PubMed 16820547Tobin 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.
PubMed 17613164Varenicline (CHANTIX): a stop-smoking pill. ORL Head Neck Nurs. 2006 Fall;24(4):18-9.
PubMed 17390707Varenicline (Chantix) for tobacco dependence. Med Lett Drugs Ther. 2006 Aug 14-28;48(1241-1242):66-8. No abstract available.
PubMed 16977281Gaston 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.
PubMed 18057352
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of a Prospective Protocol for Smoking Cessation in Nonunion, Malunion, Osseous Infection, and Infected Nonunion Patients
- ClinicalTrials.gov ID
- NCT00754299
- Acronym / sponsor ID
- nicotine / 28862
- Conditions
- Fracture Nonunion, Infection
- Keywords
- nonunion/malunion osseous fractures, nicotine dependent, chronic osseous infection, infected osseous nonunions, Fracture nonunion or infection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study could not get funding; research never initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 17 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients unable to understand the protocol, patients allergic to chantix, prisoners, and pregnant patients will be excluded, and patients with pre-existing psychiatric illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Absence of infection will be assessed by lab values, wound inspection, and radiographic evaluation where indicated.
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Background: PubMed 11174159Porter 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.
- Background: PubMed 16820547Jorenby 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.
- Background: PubMed 17613164Tobin 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.
- Background: PubMed 17390707Varenicline (CHANTIX): a stop-smoking pill. ORL Head Neck Nurs. 2006 Fall;24(4):18-9.
- Background: PubMed 16977281Varenicline (Chantix) for tobacco dependence. Med Lett Drugs Ther. 2006 Aug 14-28;48(1241-1242):66-8. No abstract available.
- Background: PubMed 18057352Gaston 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Spence Reid, MD principal investigator
Penn State Milton S. Hershey Medica Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture Nonunion and Infection, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00754299, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.