SmokingNCT05859451
Effect of Tobacco Heating System (THS) on Closed Lower Limb Fracture Healing
A study testing Tobacco Heating System (THS) and Smoking abstinence in people with Smoking and Tibia Fracture, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Tibia Fracture
- What is being tested?
- Tobacco Heating System (THS) and Smoking abstinence
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 2 Jun 2023to 17 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Siegfried Weller Institutes, BG-Trauma Clinic, Department of Traumatology, Eberhard Karls University Tübingen
Tübingen, Baden-Wurttemberg, 72076
Andreas K. Nüssler, Prof. Dr., +49070716061065, andreas.nuessler@med.uni-tuebingen.de
Benedik J. Braun, PD. Dr. med., +49070716063017, bbraun@bgu-tuebingen.de
About this study
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
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).
- Conditions
- Smoking, Tibia Fracture
- Being tested
- Tobacco Heating System (THS), Smoking abstinence
- Keywords
- Bone healing, Tobacco heating system, Smoking cessation
- Medical subject headings
- Smoking, Tibial Fractures, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco Heating System (THS)Device
Also called IQOS 3 DUO
Participant who are not willing to quit cigarette smoking during the study duration will switch from cigarettes to using THS
Smoking abstinenceOther
Participant who are willing to quit cigarette smoking and will not use any electronic nicotine delivery system during the study duration
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Tobacco Heating System (THS) |
| 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 Receives: Other: Smoking abstinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Procollagen Type 1 N-Terminal Propeptide (CICP)
Marker collagen formation - bone formation
Measured: 6 months after tibia fracture surgery
Secondary outcomes (18)
Concentration of Alkaline Phosphatase (BAP)
Marker osteoblast activity
Measured: 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
Decoy receptor RANKL - inhibit osteoclast differentiation
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 6 months after tibia fracture surgery
Number of bridged cortices in computed tomography scan
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 6 months after tibia fracture surgery
Number of complications associated with the healing process
Measured: 6 months after tibia fracture surgery
Number of hospital stay and incapacity to work [days]
Measured: 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.
Measured: 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).
Measured: 6 months after tibia fracture surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start2 Jun 2023
- Primary completion15 Oct 2025 (estimated)
- Study completion17 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Philip Morris Products S.A.
- Responsible party
- Principal investigator, Prof. Dr. rer. nat. Andreas Nüssler, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859451
- Sponsor's protocol ID
- IIS.SWI-THS.2022
- Status last verified
- Dec 2024
- First submitted
- 30 Mar 2023
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD (in an anonymous form) that underlie results in a publication
Publications
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.
PubMed 32952862Weng 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.
PubMed 36708864Moritz 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05859451
- Acronym / sponsor ID
- IIS.SWI-THS.2022
- Conditions
- Smoking, Tibia Fracture
- Keywords
- Bone healing, Tobacco heating system, Smoking cessation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Philip Morris Products S.A.
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 17 Apr 2026 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Tobacco Heating System (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 |
| Ex Smokers | Active comparator | Other: Smoking abstinenceParticipants subject to an orthopedic surgery will not smoke cigarettes or use electronic nicotine deliver systems for a period of 6 month post surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Smokers with 10-20 packyears smoking history.
- Smoking history >10 years.
- Decision not to participate in the free smoking cessation seminars.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobacco Heating System (THS)Also: IQOS 3 DUOParticipant who are not willing to quit cigarette smoking during the study duration will switch from cigarettes to using THS | Device | Smokers willing to switch to THS |
| Smoking abstinenceParticipant who are willing to quit cigarette smoking and will not use any electronic nicotine delivery system during the study duration | Other | Ex Smokers |
Primary outcome
Concentration of Procollagen Type 1 N-Terminal Propeptide (CICP)
Time frame: 6 months after tibia fracture surgery
Marker collagen formation - bone formation
18 secondary outcomes
Concentration of Alkaline Phosphatase (BAP)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 6 months after tibia fracture surgery
Number of bridged cortices in computed tomography scan
Time frame: 6 months after tibia fracture surgery
Bone Stiffness by a CT-based finite element method
Time frame: 6 months after tibia fracture surgery
Functional index in trauma (FIX-IT) - Score
Time frame: 6 months after tibia fracture surgery
Loading of the injured extremity
Time frame: 6 months after tibia fracture surgery
Lower Extremity Functional Scale (LEFS) - Score
Time frame: 6 months after tibia fracture surgery
Number of complications associated with the healing process
Time frame: 6 months after tibia fracture surgery
Number of hospital stay and incapacity to work [days]
Time frame: 6 months after tibia fracture surgery
Physicians Global Assessment to measure quality of life (PROMIS GH10 v 1.2) - Score
Time frame: 6 months after tibia fracture surgery
Visual Analog Score for pain (VAS) - Score
Time frame: 6 months after tibia fracture surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Background: PubMed 32952862Aspera-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.
- Background: PubMed 36708864Weng 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.
- BackgroundMoritz 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.
- Individual participant dataSharing planned: Yes. All IPD (in an anonymous form) that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco Heating System (THS) and Smoking abstinence in people with Smoking and Tibia Fracture, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas K. Nüssler, Prof. Dr. (+49070716061065, andreas.nuessler@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Procollagen Type 1 N-Terminal Propeptide (CICP) (time frame: 6 months after tibia fracture surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05859451, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.