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

NCT05859451 | Recruiting DMC

• 1 other identifier: IIS.SWI-THS.2022
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Bone healing; Tobacco heating system; Smoking cessation

Outcome Measures

Primary Outcomes (1)

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

  Marker collagen formation - bone formation

  6 months after tibia fracture surgery

Secondary Outcomes (18)

• Concentration of Alkaline Phosphatase (BAP)

  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

  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

  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)

  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)

  6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)

Other Outcomes (15)

• 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)

• 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)

• 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)

Study Arms (3)

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

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

Other: Smoking abstinence

Interventions

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

Also known as: IQOS 3 DUO

Smokers willing to switch to THS

Smoking abstinence OTHER

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

Ex Smokers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Philip Morris Products S.A.: collaborator

Study Sites (1)

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

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Related Publications (3)

• 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.

  PMID: 32952862 BACKGROUND

• 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.

  PMID: 36708864 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Smoking; Tibial Fractures; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Fractures, Bone; Wounds and Injuries; Leg Injuries; Health Behavior

Central Study Contacts

Andreas K. Nüssler, Prof. Dr.

CONTACT

+49070716061065; andreas.nuessler@med.uni-tuebingen.de

Benedikt J. Braun, PD. Dr.

CONTACT

+49070716063017; bbraun@bgu-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor Doctor

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: May 16, 2023
• Study Start: June 2, 2023
• Primary Completion: October 15, 2025
• Study Completion: April 17, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after results are published in peer-reviewed international journal

Locations

DE (1)