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| Name | Class |
|---|---|
| Philip Morris Products S.A. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobacco Heating System (THS) | Device | Participant who are not willing to quit cigarette smoking during the study duration will switch from cigarettes to using THS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Procollagen Type 1 N-Terminal Propeptide (CICP) | Marker collagen formation - bone formation | 6 months after tibia fracture surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Alkaline Phosphatase (BAP) | Marker osteoblast activity | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Soluble intercellular adhesion molecule-1 (sICAM-1) | 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 High densitiy lipoprotein cholesterol levels (HDL) |
Inclusion Criteria:
Additional inclusion criteria for the smoking and THS groups:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas K. Nüssler, Prof. Dr. | Contact | +49070716061065 | andreas.nuessler@med.uni-tuebingen.de | |
| Benedikt J. Braun, PD. Dr. | Contact | +49070716063017 | bbraun@bgu-tuebingen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siegfried Weller Institutes, BG-Trauma Clinic, Department of Traumatology, Eberhard Karls University Tübingen | Recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32952862 | Background | 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. | |
| 36708864 |
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All IPD (in an anonymous form) that underlie results in a publication
6 months after results are published in peer-reviewed international journal
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 21, 2026 | |
| Reset | Jun 17, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 21, 2026 | Jun 17, 2026 |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D013978 | Tibial Fractures |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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|
| Smoking abstinence | Other | Participant who are willing to quit cigarette smoking and will not use any electronic nicotine delivery system during the study duration |
|
Decoy receptor RANKL - inhibit osteoclast differentiation
| 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 | 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 | 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) |
| 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) |
| 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 conventional X-ray | 6 months after tibia fracture surgery |
| Number of bridged cortices in computed tomography scan | 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 | 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). | 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. | 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. | 6 months after tibia fracture surgery |
| Number of complications associated with the healing process | 6 months after tibia fracture surgery |
| Number of hospital stay and incapacity to work [days] | 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. | 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). | 6 months after tibia fracture surgery |
| 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 Leucocytes | 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 Erythrocytes | 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 Hemoglobin | 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 Thrombocytes | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) |
| Mean corpuscular volume | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) |
| Hematocrit levels | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) |
| Mean corpuscular hemoglobin levels | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) |
| Corpuscular hemoglobin concentration | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) |
| Protein c reactive levels | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) |
| Alcohol consume | Compensation cigarette abstinence with alcohol | 6 months after tibia surgery |
| Questionnaire on Smoking Urges (QSU-G) - Score | 6 months after tibia surgery |
| Smoking behaviour | Number of cigarettes or THS heets consume | 6 months after tibia surgery |
| Nicotine withdrawal syndrome assessment - Checklist | 6 months after tibia surgery |
| 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. |
| Background | 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. |
| D015438 |
| Health Behavior |