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

Smoking Clinical Trial

Official title:

Evaluation of Tobacco Heating System (THS) Compared to Conventional Cigarette Smoking During the Closed Tibia Fracture Healing in Orthopedic Smokers' Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05859451
• Other study ID #: IIS.SWI-THS.2022
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2023
• Est. completion date: April 17, 2026

Study information

• Verified date: November 2023
• Source: University Hospital Tuebingen
• Contact: Andreas K. Nüssler, Prof. Dr.
• Phone: +49070716061065
• Email: andreas.nuessler[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 tibia 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 17, 2026
• Est. primary completion date: October 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Closed tibial fracture (according to AO/OTA classification: 41A2-41C3, 42A-C, 43A-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 tibial fractures or concomitant injuries or complications requiring surgery existing at the time of surgical indication.

• Initial surgical treatment of the tibial 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).

Related Conditions & MeSH terms

• Fractures, Bone
• Smoking
• Tibia Fracture
• Tibial Fractures

Intervention

Device:
• Tobacco Heating System (THS)
Participant who are not willing to quit cigarette smoking during the study duration will switch from cigarettes to using THS

Other:
• Smoking abstinence
Participant who are willing to quit cigarette smoking and will not use any electronic nicotine delivery system during the study duration

Locations

Country	Name	City	State
Germany	Siegfried Weller Institutes, BG-Trauma Clinic, Department of Traumatology, Eberhard Karls University Tübingen	Tübingen	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Philip Morris Products S.A.

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Concentration of High densitiy lipoprotein cholesterol levels (HDL)		6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	Alcohol consume	Compensation cigarette abstinence with alcohol	6 months after tibia surgery
Other	Questionnaire on Smoking Urges (QSU-G) - Score		6 months after tibia surgery
Other	Smoking behaviour	Number of cigarettes or THS heets consume	6 months after tibia surgery
Other	Nicotine withdrawal syndrome assessment - Checklist		6 months after tibia surgery
Primary	Concentration of Procollagen Type 1 N-Terminal Propeptide (CICP)	Marker collagen formation - bone formation	6 months after tibia fracture surgery
Secondary	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)
Secondary	Concentration of Osteoprogesterin	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)
Secondary	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)
Secondary	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)
Secondary	Concentration of Interleukin 1 beta (IL-1ß)		6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
Secondary	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)
Secondary	Concentration of Interferon gamma (IFN-?)		6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
Secondary	Concentration of Tumor Necrosis Factor Alpha (TNF-a)		6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)
Secondary	Number of bridged cortices in conventional X-ray		6 months after tibia fracture surgery
Secondary	Number of bridged cortices in computed tomography scan		6 months after tibia fracture surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of complications associated with the healing process		6 months after tibia fracture surgery
Secondary	Number of hospital stay and incapacity to work [days]		6 months after tibia fracture surgery
Secondary	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
Secondary	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