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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
150
Participant who are not willing to quit cigarette smoking during the study duration will switch from cigarettes to using THS
Participant who are willing to quit cigarette smoking and will not use any electronic nicotine delivery system during the study duration
Siegfried Weller Institutes, BG-Trauma Clinic, Department of Traumatology, Eberhard Karls University Tübingen
Tübingen, Baden-Wurttemberg, Germany
RECRUITINGConcentration of Procollagen Type 1 N-Terminal Propeptide (CICP)
Marker collagen formation - bone formation
Time frame: 6 months after tibia fracture surgery
Concentration of Alkaline Phosphatase (BAP)
Marker osteoblast activity
Time frame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
Concentration of Osteoprogesterin
Decoy receptor RANKL - inhibit osteoclast differentiation
Time frame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
Concentration of Osteopontin
Extracellular structural protein and an organic component of bone - favors osteoclast adherence
Time frame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
Concentration of N-terminal telopeptide (NTx)
Marker collagen degradation - bone resorption
Time frame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
Concentration of Interleukin 1 beta (IL-1β)
Time frame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
Concentration of Interleukin 6 (IL-6)
Time frame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
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Concentration of Interferon gamma (IFN-γ)
Time frame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
Concentration of Tumor Necrosis Factor Alpha (TNF-α)
Time frame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
Number of bridged cortices in conventional X-ray
Time frame: 6 months after tibia fracture surgery
Number of bridged cortices in computed tomography scan
Time frame: 6 months after tibia fracture surgery
Bone Stiffness by a CT-based finite element method
Finite element method will be used to simulate the mechanical behavior (linear-elastic range) of the tibia and predict bending stiffness under a 3-point bending test
Time frame: 6 months after tibia fracture surgery
Functional index in trauma (FIX-IT) - Score
Assess weight-bearing and pain in patients with lower extremity fractures eight-bearing and pain in patients with lower extremity fractures. The score rank from 0 to 12 points in 2 domains: the ability to bear weight (maximum 6 points) and pain at the fracture site (maximum 6 points). The scores in both domains, which are weighted equally, are summed to obtain the final total score; (maximum 12 points indicates the highest level of function).
Time frame: 6 months after tibia fracture surgery
Loading of the injured extremity
The time period with no, sole contact, partial or full load on the injured extremity.
Time frame: 6 months after tibia fracture surgery
Lower Extremity Functional Scale (LEFS) - Score
The Lower Extremity Functional Scale (LEFS) is a questionnaire (20 questions) about a person's ability to perform everyday tasks. The LEFS will be used to evaluate the functional impairment of a patient with a disorder of lower extremity. The score rank from 0 to 80 points. The maximum score (80 point) indicates no functional limitations.
Time frame: 6 months after tibia fracture surgery
Number of complications associated with the healing process
Time frame: 6 months after tibia fracture surgery
Number of hospital stay and incapacity to work [days]
Time frame: 6 months after tibia fracture surgery
Physicians Global Assessment to measure quality of life (PROMIS GH10 v 1.2) - Score
The Global Health Patient-Reported Outcomes Measurement Information System (PROMIS- 10) scale is a ten-item patient reported measure of physical, mental and social health. Two summary scores are calculated from the results of the questions: a global physical health score and a global mental health score. These scores are then normalized to the general population using the "T-score." The score ranges from 0 to 20 points. 0 points represent the most severe physical and/or mental impairment of the patient, while 20 points represent the best possible health status.
Time frame: 6 months after tibia fracture surgery
Visual Analog Score for pain (VAS) - Score
Visual Analog Scale for Pain (VAS) provide an estimate of patients' pain intensity. Scale from cero (no pain) to 10 (extreme pain).
Time frame: 6 months after tibia fracture surgery