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NCT Number: NCT06361459

Stop Smoking in Spine Surgery

Patients that are subjected to a medium complex surgical intervention in neck (posterior) or lumbar spine (posterior) with instrumentation are motivated to stop smoking. The outcome data of patients that stop and that continue smoking will be compared. A group of non smokers is evaluated as a control group. Particularly clinical outcome is evaluated, as well as radiological outcome.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Centre

Leiden, South Holland, 2300RC, Netherlands

Location status: Recruiting

Location contact

carmen vleggeert-lankamp, MD MSc PhD

CONTACT

[email protected]

+31630925428

About this study

Rationale: Optimizing outcomes of instrumented neck and back surgery Objective: To demonstrate that smoking cessation in the postoperative period has a positive impact on the clinical and radiological outcomes of instrumented spine surgery Study design: This is a multicenter observational cohort study with three groups of patients indicated to undergo moderately complex instrumented spinal surgery: a group of patients who continue to smoke is compared with a group who stop smoking in the peri-operative period of time. In addition, the results of a group of patients who do not smoke are recorded. Follow-up moments are baseline, 2, 6 and 12 months after surgery.

Study population: Patients between 18 and 75 years of age, who are candidates for moderately complex instrumented surgery of the neck or low back. Patients undergoing surgery for malignancy or trauma are excluded.

Intervention: If patients indicate that they are open to quitting smoking, they will be offered the SineFuma program. After 4 weeks, testing of nicotine in the urine will check whether smoking has actually stopped.

Study parameters: Primary outcome measure is the Oswestry Disability Index (low back) or the Neck Disability Index (neck). Furthermore, the VAS leg pain (or arm pain) and VAS back pain (or neck pain), the Hospital Anxiety and Depression Scale, the EuroQol and the patient's perceived recovery will be evaluated. The bony fusion will be assessed radiologically by CT at 6 and 12 months.

This is a multicenter observational cohort study adjusted for age and ASA score.

Evaluation moments: Patients will be asked to complete questionnaires at baseline and 2, 6 and 12 months after surgery. Patients who indicate that they have stopped smoking will be asked to submit a urine sample. For smokers who have to quit first, there is a second baseline measurement at the time they are scheduled for surgery. Data will be collected per center and brought together in the Data Coordination Center in Leiden (LUMC).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • candidates for moderately complex instrumented surgery of the neck or low back.

Exclusion criteria

  • Patients undergoing surgery for malignancy or trauma are excluded.
  • non Dutch speaking patients
  • pregnancy

Treatment and study plan

Stop smoking

Behavioral

Sine fuma program is offered. nicotine is checked in urine

Primary outcomes

  1. ODI or NDI

    Time frame: baseline, 2, 6 and 12 months post surgery

    Oswestry Disability Index (lumbar spine) or Neck Disability Index (neck surgery), ranging from 0 (best) to 100 (worst)

Secondary outcomes

  1. VAS leg or arm pain

    Time frame: baseline, 2, 6 and 12 months post surgery

    VAS leg (lumbar spine) or VAS arm pain (neck surgery),ranging from 0 mm (best) to 100 mm (worst)

  2. HADS

    Time frame: baseline, 2, 6 and 12 months post surgery

    Hospital Anxiety and Depression Scale, 2 scales ranging from 0 (best) to 18 (worst)

  3. EuroQol

    Time frame: baseline, 2, 6 and 12 months post surgery

    quality of life, ranging from 0 (worst) to 1,0 (best)

  4. perceived recovery

    Time frame: 2, 6 and 12 months post surgery

    perceived recovery in 7 grades ranging from 'completely recovered (= 1)' to 'much worse than I was before intervention (=7)'

  5. radiological evaluation for fusion

    Time frame: 6 and 12 months after surgery

    CT scan to evaluate speed of fusion

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Alrijne Hospital
  • Haga Hospital
  • Medical Center Haaglanden
  • Spaarne Gasthuis

Registry information

Official study title

Evaluation of the Influence of Stop Smoking to the Clinical and Radiological Outcome of Instrumented Neck and Back Surgery

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2024
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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