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Stop Smoking in Spine Surgery

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06361459
Enrollment
210
Registered
2024-04-11
Start date
2023-07-06
Completion date
2026-12-31
Last updated
2024-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

smoking cessation, instrumented surgery, spondylodesis

Brief summary

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.

Detailed description

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).

Interventions

BEHAVIORALStop smoking

Sine fuma program is offered. nicotine is checked in urine

Sponsors

Medical Center Haaglanden
CollaboratorOTHER
Haga Hospital
CollaboratorOTHER
Alrijne Hospital
CollaboratorOTHER
Spaarne Gasthuis
CollaboratorOTHER
Leiden University Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

three study groups: group that does not smoke, group that smokes and stops, group that smokes and does not stop

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ODI or NDIbaseline, 2, 6 and 12 months post surgeryOswestry Disability Index (lumbar spine) or Neck Disability Index (neck surgery), ranging from 0 (best) to 100 (worst)

Secondary

MeasureTime frameDescription
VAS leg or arm painbaseline, 2, 6 and 12 months post surgeryVAS leg (lumbar spine) or VAS arm pain (neck surgery),ranging from 0 mm (best) to 100 mm (worst)
HADSbaseline, 2, 6 and 12 months post surgeryHospital Anxiety and Depression Scale, 2 scales ranging from 0 (best) to 18 (worst)
EuroQolbaseline, 2, 6 and 12 months post surgeryquality of life, ranging from 0 (worst) to 1,0 (best)
perceived recovery2, 6 and 12 months post surgeryperceived recovery in 7 grades ranging from 'completely recovered (= 1)' to 'much worse than I was before intervention (=7)'
radiological evaluation for fusion6 and 12 months after surgeryCT scan to evaluate speed of fusion

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026