Effect of Tobacco Heating System (THS) on Closed Lower Limb Fracture Healing
Trial Parameters
Brief 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 Criteria
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.