Effect of Tobacco Heating System (THS) on Closed Lower Limb Fracture Healing

Официальное название

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

Обзор

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).

Вмешательства

• Устройство Tobacco Heating System (THS)
  Participant who are not willing to quit cigarette smoking during the study duration will switch from cigarettes to using THS
• Другое Smoking abstinence
  Participant who are willing to quit cigarette smoking and will not use any electronic nicotine delivery system during the study duration

Первичные конечные точки

• Concentration of Procollagen Type 1 N-Terminal Propeptide (CICP) [Срок оценки: 6 months after tibia fracture surgery]

Вторичные конечные точки (12)

• Concentration of Alkaline Phosphatase (BAP) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 Interferon gamma (IFN-γ) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 6 months after tibia fracture surgery]
• Number of bridged cortices in computed tomography scan [Срок оценки: 6 months after tibia fracture surgery]
• Bone Stiffness by a CT-based finite element method [Срок оценки: 6 months after tibia fracture surgery]
• Functional index in trauma (FIX-IT) - Score [Срок оценки: 6 months after tibia fracture surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Германия · 1 центр

• Siegfried Weller Institutes, BG-Trauma Clinic, Department of Traumatology, Eberhard Karls — Tübingen

Публикации

• Aspera-Werz RH, Ehnert S, Muller M, Zhu S, Chen T, Weng W, Jacoby J, Nussler AK. Assessment of tobacco heating system 2.4 on osteogenic differentiation of mesenchymal stem cells and primary human osteoblasts compared to conventional cigarettes. World J Stem Cells. 2020 Aug 26;12(8):841-856. doi: 10.4252/wjsc.v12.i8.841. PMID 32952862
• Weng W, Bovard D, Zanetti F, Ehnert S, Braun B, Uynuk-Ool T, Histing T, Hoeng J, Nussler AK, Aspera-Werz RH. Tobacco heating system has less impact on bone metabolism than cigarette smoke. Food Chem Toxicol. 2023 Mar;173:113637. doi: 10.1016/j.fct.2023.113637. Epub 2023 Jan 25. PMID 36708864
• Moritz Herbst, Romina Aspera-Werz, Benedikt Braun, Kevin Schulz, et al. (2024). Evaluation of the Tobacco Heating System (THS) During Closed Lower Limb Fracture Healing in Trauma Smokers' Patients. Qeios. doi:10.32388/DE0EAE.2.

Идентификаторы

NCT: NCT05859451 · IIS.SWI-THS.2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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