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

Browse trials for

• Smoking 325
• Tibial Fractures 162
• Smoking Cessation 350

Keywords

• Bone healing
• Tobacco heating system
• Smoking cessation

Smoking

325 studies on the registry are indexed under Smoking; 141 are open to participants now.

This study's planned enrollment of 150 is above the median of 117 across 250 interventional studies indexed under Smoking.

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 490 studies on the registry; 108 are open to participants now.

Study arms

• No intervention
  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

• Experimental
  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

  Device: Tobacco Heating System (THS)

• Active comparator
  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

  Other: Smoking abstinence

Interventions

• DeviceTobacco Heating System (THS)

  Participant who are not willing to quit cigarette smoking during the study duration will switch from cigarettes to using THS

  Also known as: IQOS 3 DUO

• OtherSmoking abstinence

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

Primary outcomes

1. Concentration of Procollagen Type 1 N-Terminal Propeptide (CICP)

   Marker collagen formation - bone formation

   Time frame: 6 months after tibia fracture surgery

Secondary outcomes

1. Concentration of Alkaline Phosphatase (BAP)

   Marker osteoblast activity

   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)

2. Concentration of Osteoprogesterin

   Decoy receptor RANKL - inhibit osteoclast differentiation

   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)

3. Concentration of Osteopontin

   Extracellular structural protein and an organic component of bone - favors osteoclast adherence

   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)

4. Concentration of N-terminal telopeptide (NTx)

   Marker collagen degradation - bone resorption

   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)

5. 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)

6. 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)

7. 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)

8. 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)

9. Number of bridged cortices in conventional X-ray

   Time frame: 6 months after tibia fracture surgery

10. Number of bridged cortices in computed tomography scan

    Time frame: 6 months after tibia fracture surgery

11. 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

    Time frame: 6 months after tibia fracture surgery

12. 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).

    Time frame: 6 months after tibia fracture surgery

13. Loading of the injured extremity

    The time period with no, sole contact, partial or full load on the injured extremity.

    Time frame: 6 months after tibia fracture surgery

14. 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.

    Time frame: 6 months after tibia fracture surgery

15. Number of complications associated with the healing process

    Time frame: 6 months after tibia fracture surgery

16. Number of hospital stay and incapacity to work [days]

    Time frame: 6 months after tibia fracture surgery

17. 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.

    Time frame: 6 months after tibia fracture surgery

18. 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).

    Time frame: 6 months after tibia fracture surgery

Other outcomes

1. Concentration of Soluble intercellular adhesion molecule-1 (sICAM-1)

   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)

2. Concentration of High densitiy lipoprotein cholesterol levels (HDL)

   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)

3. Concentration of Leucocytes

   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)

4. Concentration of Erythrocytes

   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)

5. Concentration of Hemoglobin

   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)

6. Concentration of Thrombocytes

   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)

7. Mean corpuscular volume

   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)

8. Hematocrit levels

   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)

9. Mean corpuscular hemoglobin levels

   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)

10. Corpuscular hemoglobin concentration

    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)

11. Protein c reactive levels

    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)

12. Alcohol consume

    Compensation cigarette abstinence with alcohol

    Time frame: 6 months after tibia surgery

13. Questionnaire on Smoking Urges (QSU-G) - Score

    Time frame: 6 months after tibia surgery

14. Smoking behaviour

    Number of cigarettes or THS heets consume

    Time frame: 6 months after tibia surgery

15. Nicotine withdrawal syndrome assessment - Checklist

    Time frame: 6 months after tibia surgery

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 32952862 ↗
• 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. PubMed 36708864 ↗
• 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.

Individual participant data

Plan to share: Yes — All IPD (in an anonymous form) that underlie results in a publication

Supporting information: Study protocol

Time frame: 6 months after results are published in peer-reviewed international journal