NCT05859451招募中不适用
Evaluation of Tobacco Heating System (THS) Compared to Conventional Cigarette Smoking During the Closed Lower Limb (Tibia and Femur) Fracture Healing in Orthopedic Smokers' Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Concentration of Procollagen Type 1 N-Terminal Propeptide (CICP)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Smokers
No Intervention
Participants subject to an orthopedic surgery (does not want to quit smoking conventional cigarettes) will continue smoking conventional cigarettes ad libitum for a period of 6 month post surgery
Smokers willing to switch to THS
Experimental
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
干预措施: Tobacco Heating System (THS) (Device)
Ex Smokers
Active Comparator
Participants subject to an orthopedic surgery will not smoke cigarettes or use electronic nicotine deliver systems for a period of 6 month post surgery
干预措施: Smoking abstinence (Other)
结局指标
主要结局
Concentration of Procollagen Type 1 N-Terminal Propeptide (CICP)
时间窗: 6 months after tibia fracture surgery
Marker collagen formation - bone formation
次要结局
- 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))
- 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)
- Loading of the injured extremity(6 months after tibia fracture surgery)
- 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))
- 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))
- Bone Stiffness by a CT-based finite element method(6 months after tibia fracture surgery)
- Lower Extremity Functional Scale (LEFS) - Score(6 months after tibia fracture surgery)
- 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))
- 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)
- 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)
- Physicians Global Assessment to measure quality of life (PROMIS GH10 v 1.2) - Score(6 months after tibia fracture surgery)
- Visual Analog Score for pain (VAS) - Score(6 months after tibia fracture surgery)
研究者
Prof. Dr. rer. nat. Andreas Nüssler
Profesor Doctor
University Hospital Tuebingen
研究点 (1)
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