ClinicalTrials.gg
Status unknownNCT00704015Updated Jun 24, 2008

Smoking Cessation Intervention in Acute Orthopedic Surgery

An interventional study of Smoking cessation in Smoking Cessation and Fracture, sponsored by Karolinska Institutet. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2008-06-24.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2008), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The purpose of this study was to evaluate if an intervention with smoking cessation starting during the acute hospitalization period and continuing during the acute postoperative phase of 6 weeks would reduce the frequency of overall postoperative complications and wound infections in patients with acute musculoskeletal injuries requiring surgical treatment. The secondary aims were to study the short and the long term (1 year) abstinence rate, functional outcome, health related quality of life as well as costs.

Read the detailed description

Tobacco smoking is a major health problem. The effect of a smoking cessation intervention prior to elective orthopedic surgery has been evaluated previously. However, as far as we know there are no prospective randomized studies investigating the effect of smoking cessation on complication rate in patients with acute musculoskeletal injuries.

02

Conditions studied

  • Smoking Cessation
  • Fracture

Keywords

  • Smoking cessation
  • Acute injury
  • Musculoskeletal
  • Postoperative complications
03

In context

Smoking Cessation

350 studies on the registry are indexed under Smoking Cessation; 145 are open to participants now.

This study's enrollment of 105 is below the median of 150 across 326 interventional studies indexed under Smoking Cessation.

Browse Smoking Cessation studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,145 studies on the registry; 274 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • daily smoker: more than 2 cigarettes per day for at least one year
  • acute fracture of an extremity, in need of surgical treatment
  • oral and written consent

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • alcohol or drug abuse prohibiting compliance with the study protocol
  • living outside the county of Stockholm prohibiting follow-up
  • a severe mental illness including dementia
  • inability to read and understand Swedish
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
105 participants (actual)

Study arms

  • Experimental
    A

    Smoking cessation

    Behavioral: Smoking cessation

  • No intervention
    B

Interventions

  • BehavioralSmoking cessation

    Nurses, specifically trained for smoking cession program, contacted the patients at the orthopedic wards and initiated the intervention (stop smoking) within 1-2 days after acute hospitalization. The intervention included one or two personal meetings and weekly phone contacts during 6 weeks with a trained nurse. A phone number to a non-smoking hotline was provided for all patients. The patients were continuously encouraged not to smoke and free nicotine substitution (Nicorette®) was offered those who needed it. No other drug therapy was used.

06

What researchers measure

Primary outcomes

  1. Postoperative complications including wound related complications

    Time frame: 6-12 weeks

Secondary outcomes

  1. Abstinence rate and functional outcome including HRQoL

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00704015
Collaborators
Region Stockholm
First posted
Jun 24, 2008
Start date
Feb 2004
Primary completion
Dec 2006
Completion
Jun 2008 (estimated)
Last update
Jun 24, 2008

Study contacts

Sari Ponzer, MD, Prof
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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