Effect of Tobacco Heating System (THS) on Closed Lower Limb Fracture Healing
NCT ID: NCT05859451
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
150 participants
INTERVENTIONAL
2023-06-02
2026-04-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Smokers
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
No interventions assigned to this group
Smokers willing to switch to 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
Tobacco Heating System (THS)
Participant who are not willing to quit cigarette smoking during the study duration will switch from cigarettes to using THS
Ex Smokers
Participants subject to an orthopedic surgery will not smoke cigarettes or use electronic nicotine deliver systems for a period of 6 month post surgery
Smoking abstinence
Participant who are willing to quit cigarette smoking and will not use any electronic nicotine delivery system during the study duration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tobacco Heating System (THS)
Participant who are not willing to quit cigarette smoking during the study duration will switch from cigarettes to using THS
Smoking abstinence
Participant who are willing to quit cigarette smoking and will not use any electronic nicotine delivery system during the study duration
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Smokers with 10-20 packyears smoking history.
* Smoking history \>10 years.
* Decision not to participate in the free smoking cessation seminars.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Philip Morris Products S.A.
INDUSTRY
University Hospital Tuebingen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Dr. rer. nat. Andreas Nüssler
Profesor Doctor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Siegfried Weller Institutes, BG-Trauma Clinic, Department of Traumatology, Eberhard Karls University Tübingen
Tübingen, Baden-Wurttemberg, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Andreas K. Nüssler, Prof. Dr.
Role: primary
Benedik J. Braun, PD. Dr. med.
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IIS.SWI-THS.2022
Identifier Type: -
Identifier Source: org_study_id