Clinical trial NCT05859451: Effect of Tobacco Heating System (THS) on Closed Lower Limb Fracture Healing
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking
Tibia Fracture
Keywords: Bone healing
Tobacco heating system
Smoking cessation
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Philip Morris Products S.A.
First posted: 2023-05-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Concentration of Procollagen Type 1 N-Terminal Propeptide (CICP)
timeFrame: 6 months after tibia fracture surgery
Secondary outcomes:
measure: Concentration of Alkaline Phosphatase (BAP)
timeFrame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
measure: Concentration of Osteoprogesterin
timeFrame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
measure: Concentration of Osteopontin
timeFrame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
measure: Concentration of N-terminal telopeptide (NTx)
timeFrame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
measure: Concentration of Interleukin 1 beta (IL-1β)
timeFrame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
measure: Concentration of Interleukin 6 (IL-6)
timeFrame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
measure: Concentration of Interferon gamma (IFN-γ)
timeFrame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
measure: Concentration of Tumor Necrosis Factor Alpha (TNF-α)
timeFrame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
measure: Number of bridged cortices in conventional X-ray
timeFrame: 6 months after tibia fracture surgery
measure: Number of bridged cortices in computed tomography scan
timeFrame: 6 months after tibia fracture surgery
measure: Bone Stiffness by a CT-based finite element method
timeFrame: 6 months after tibia fracture surgery
measure: Functional index in trauma (FIX-IT) - Score
timeFrame: 6 months after tibia fracture surgery
measure: Loading of the injured extremity
timeFrame: 6 months after tibia fracture surgery
measure: Lower Extremity Functional Scale (LEFS) - Score
timeFrame: 6 months after tibia fracture surgery
measure: Number of complications associated with the healing process
timeFrame: 6 months after tibia fracture surgery
measure: Number of hospital stay and incapacity to work [days]
timeFrame: 6 months after tibia fracture surgery
measure: Physicians Global Assessment to measure quality of life (PROMIS GH10 v 1.2) - Score
timeFrame: 6 months after tibia fracture surgery
measure: Visual Analog Score for pain (VAS) - Score
timeFrame: 6 months after tibia fracture surgery
Other outcomes:
measure: Concentration of Soluble intercellular adhesion molecule-1 (sICAM-1)
timeFrame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
measure: Concentration of High densitiy lipoprotein cholesterol levels (HDL)
timeFrame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
measure: Concentration of Leucocytes
timeFrame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
measure: Concentration of Erythrocytes
timeFrame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
measure: Concentration of Hemoglobin
timeFrame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
measure: Concentration of Thrombocytes
timeFrame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
measure: Mean corpuscular volume
timeFrame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
measure: Hematocrit levels
timeFrame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
measure: Mean corpuscular hemoglobin levels
timeFrame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
measure: Corpuscular hemoglobin concentration
timeFrame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
measure: Protein c reactive levels
timeFrame: 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
measure: Alcohol consume
timeFrame: 6 months after tibia surgery
measure: Questionnaire on Smoking Urges (QSU-G) - Score
timeFrame: 6 months after tibia surgery
measure: Smoking behaviour
timeFrame: 6 months after tibia surgery
measure: Nicotine withdrawal syndrome assessment - Checklist
timeFrame: 6 months after tibia surgery
Locations:
city: Tübingen
country: Germany
facility: Siegfried Weller Institutes, BG-Trauma Clinic, Department of Traumatology, Eberhard Karls University Tübingen
state: Baden-Württemberg
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.