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NCT Number: NCT05859451

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

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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Key information

Conditions

Smoking Behavior Fractures, Bone Health Behavior Leg Injuries Smoking Cessation Tibia Fracture Tibial Fractures Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siegfried Weller Institutes, BG-Trauma Clinic, Department of Traumatology, Eberhard Karls University Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location status: Recruiting

Location contact

Andreas K. Nüssler, Prof. Dr.

CONTACT

[email protected]

+49070716061065

Andreas K. Nüssler, Prof. Dr.

PRINCIPAL_INVESTIGATOR

Benedik J. Braun, PD. Dr. med.

CONTACT

[email protected]

+49070716063017

Benedik J. Braun, PD. Dr. med.

SUB_INVESTIGATOR

Romina H. Aspera-Werz, Dr. sc. hum.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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).

Treatment and study plan

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

Other names: IQOS 3 DUO

smoking abstinence

Other

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)

    Time frame: 6 months after tibia fracture surgery

    Marker collagen formation - bone formation

Secondary outcomes

  1. 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)

    Marker osteoblast activity

  2. 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)

    Decoy receptor RANKL - inhibit osteoclast differentiation

  3. 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)

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

  4. 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)

    Marker collagen degradation - bone resorption

  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

    Time frame: 6 months after tibia fracture surgery

    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

  12. Functional index in trauma (FIX-IT) - Score

    Time frame: 6 months after tibia fracture surgery

    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).

  13. Loading of the injured extremity

    Time frame: 6 months after tibia fracture surgery

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

  14. Lower Extremity Functional Scale (LEFS) - Score

    Time frame: 6 months after tibia fracture surgery

    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.

  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

    Time frame: 6 months after tibia fracture surgery

    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.

  18. Visual Analog Score for pain (VAS) - Score

    Time frame: 6 months after tibia fracture surgery

    Visual Analog Scale for Pain (VAS) provide an estimate of patients' pain intensity. Scale from cero (no pain) to 10 (extreme pain).

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

    Time frame: 6 months after tibia surgery

    Compensation cigarette abstinence with alcohol

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

    Time frame: 6 months after tibia surgery

  14. Smoking behaviour

    Time frame: 6 months after tibia surgery

    Number of cigarettes or THS heets consume

  15. Nicotine withdrawal syndrome assessment - Checklist

    Time frame: 6 months after tibia surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas K. Nüssler, Prof. Dr.

CONTACT

[email protected]

+49070716061065

Benedikt J. Braun, PD. Dr.

CONTACT

[email protected]

+49070716063017

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Philip Morris Products S.A.

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 16, 2023
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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