Ireland
--:--IST
Recruiting Not applicable

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

NCT05859451 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2023-06-02
Last updated
2024-12-11

Condition(s) studied

SmokingTibia Fracture

Investigational drug(s) / intervention(s)

Tobacco Heating System (THS)Smoking abstinence

Tobacco Heating System (THS): Participant who are not willing to quit cigarette smoking during the study duration will switch from cigarettes to using THS

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

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Closed tibia or femur fracture (according to AO/OTA: 41A2-41C3, 42A-C, 43A-C, 32A-C, 33A2-3, 33B-C) which is surgically treated within 14 days after the trauma at the BG trauma clinic Tübingen. Additional inclusion criteria for the smoking and THS groups: * Smokers with 10-20 packyears smoking history. * Smoking history \>10 years. * Decision not to participate in the free smoking cessation seminars. Exclusion Criteria: * Legal guardian or loss of capacity to consent. * Refusal to participate in the study. * Open fractures or concomitant injuries or complications requiring surgery existing at the time of surgical indication. * Initial surgical treatment of the fracture has occurred ex domo. * No initial surgical treatment within 14 days of sustained trauma. * Using nicotine delivery electronic devices. * Pre-existing autoimmune, immunological, bone or malignant diseases. * Pregnant, breastfeeding and women of childbearing age with existing desire to have children. * History of alcohol abuse or drug abuse. * Taking antioxidants approval by the German Federal Institute for Drugs and Medical Devices (BfArM). * Taking drugs with known effect on bone metabolism (according to Institute for medical and pharmaceutical examination issues (IMPP): allosteric CaSR modulators, bisphosphonates, calcium release inhibitors, alkaline earth ions, RANKL inhibitors, calcitriol, colecalciferol).

Primary outcome measure(s)

  • Concentration of Procollagen Type 1 N-Terminal Propeptide (CICP) — 6 months after tibia fracture surgery
    Marker collagen formation - bone formation

Trial sites (1)

FacilityCityRegionStatus
Siegfried Weller Institutes, BG-Trauma Clinic, Department of Traumatology, Eberhard Karls University Tübingen Tübingen Baden-Wurttemberg Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05859451 on ClinicalTrials.gov ↗ ← All trials in Germany