Effect of Tobacco Heating System (THS) on Closed Lower Limb Fracture Healing
- Conditions
- SmokingTibia Fracture
- Interventions
- Other: Smoking abstinenceDevice: Tobacco Heating System (THS)
- Registration Number
- NCT05859451
- Lead Sponsor
- University Hospital Tuebingen
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ex Smokers Smoking abstinence Participants subject to an orthopedic surgery will not smoke cigarettes or use electronic nicotine deliver systems for a period of 6 month post surgery Smokers willing to switch to THS Tobacco Heating System (THS) Participants subject to an orthopedic surgery (currently smoking conventional cigarettes) will start to used THS ad libitum for a period of 6 month post surgery
- Primary Outcome Measures
Name Time Method Concentration of Procollagen Type 1 N-Terminal Propeptide (CICP) 6 months after tibia fracture surgery Marker collagen formation - bone formation
- Secondary Outcome Measures
Name Time Method Concentration of Alkaline Phosphatase (BAP) 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) Marker osteoblast activity
Concentration of Osteoprogesterin 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) Decoy receptor RANKL - inhibit osteoclast differentiation
Concentration of N-terminal telopeptide (NTx) 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) Marker collagen degradation - bone resorption
Concentration of Interleukin 6 (IL-6) 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 6 months after tibia fracture surgery Bone Stiffness by a CT-based finite element method 6 months after tibia fracture surgery 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
Lower Extremity Functional Scale (LEFS) - Score 6 months after tibia fracture surgery 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.
Number of hospital stay and incapacity to work [days] 6 months after tibia fracture surgery Concentration of Osteopontin 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) Extracellular structural protein and an organic component of bone - favors osteoclast adherence
Concentration of Interleukin 1 beta (IL-1β) 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) Functional index in trauma (FIX-IT) - Score 6 months after tibia fracture surgery 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).
Number of complications associated with the healing process 6 months after tibia fracture surgery Concentration of Interferon gamma (IFN-γ) 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) 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 computed tomography scan 6 months after tibia fracture surgery Loading of the injured extremity 6 months after tibia fracture surgery The time period with no, sole contact, partial or full load on the injured extremity.
Physicians Global Assessment to measure quality of life (PROMIS GH10 v 1.2) - Score 6 months after tibia fracture surgery 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.
Visual Analog Score for pain (VAS) - Score 6 months after tibia fracture surgery Visual Analog Scale for Pain (VAS) provide an estimate of patients' pain intensity. Scale from cero (no pain) to 10 (extreme pain).
Trial Locations
- Locations (1)
Siegfried Weller Institutes, BG-Trauma Clinic, Department of Traumatology, Eberhard Karls University Tübingen
🇩🇪Tübingen, Baden-Württemberg, Germany