Evaluation of Tobacco heating system (THS) during the closed tibia fracture healing in orthopedic smokers’ patients

08/08/2022 to 31/07/2025

Delays in fracture healing, non-union, an increased complication rate, and extended hospital stay increase health system costs. Therefore, developing alternatives for smoker orthopedic patients that improve bone healing are strongly needed. Our previous study confirmed that CS is a major risk factor for complications such as infection, delayed healing, and revision surgery in orthopedic patients at BG trauma clinic. Unexpectedly, our orthopedic patients who smoke were on average 5.4 years younger than non-smokers, demonstrating the harmful effect of smoking on bone quality, with a high risk of bone fracture at younger ages. Although the positive effects associated with smoking abstinence, many smokers cannot, wish not to or fail to quit cigarette smoking. Unfortunately, non-electronic nicotine replacement therapies fail in most smokers due to a lack of the smoking ritual. Therefore, new technologies are based on preserving the smoking ritual while providing less harmful constituents and maintaining the same nicotine levels found in conventional cigarettes (e.g., Tobacco heating system [THS], e-cigarette). Our previous study showed that e-cigarette aerosol does not affect bone morphology, structure, and strength compared with CS in a mouse model exposed to these compounds for 6 months.
The study aims to investigate the role of switching from cigarette smoking to THS on the clinical outcome of closed
tibia fractures from patients of the BG trauma clinic. Validated and standardized assays and medical state will be
evaluated in orthopedic patients’ smokers or switch from CS to using THS throughout six months relative to nonsmokers (control). We hypothesize that switching to THS previous orthopedic intervention improves outcomes during tibia fracture healing in smokers’ patients due to reduce bone resorption rate consequent of the diminished activity of CS-activated osteoclast.
The study will be an open-label, three non-parallel groups, single-center clinical study. Orthopedic patients from BG trauma clinic Tübingen Germany diagnosed and treated for tibia fracture, including non-smokers and smokers, will be screened for the study.