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Effect of Tobacco Heating System (THS) on Closed Lower Limb Fracture Healing

NCT05859451 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-12-11

No results posted yet for this study

Summary

The goal of this clinical trial is to investigate the role of switching from cigarette smoking (CS) to tobacco heat system (THS) on the clinical outcome of closed lower limb (tibia and femur) fractures from smokers' orthopedic patients. Validated and standardized assays, medical state and self-reported outcomes will be evaluated in orthopedic patients' smokers or switch from CS to using THS throughout six months compare to ex-smokers (control).

Conditions

  • Smoking
  • Tibia Fracture

Interventions

DEVICE

Tobacco Heating System (THS)

Participant who are not willing to quit cigarette smoking during the study duration will switch from cigarettes to using THS

OTHER

Smoking abstinence

Participant who are willing to quit cigarette smoking and will not use any electronic nicotine delivery system during the study duration

Sponsors & Collaborators

  • Philip Morris Products S.A.

    collaborator INDUSTRY

  • University Hospital Tuebingen

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-02
Primary Completion
2025-10-15
Completion
2026-04-17

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05859451 on ClinicalTrials.gov