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Effect of Tobacco Heating System (THS) on Closed Lower Limb Fracture Healing | Clinical Trials | Clareo Health

RECRUITINGNA

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

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

NCT05859451•University Hospital Tuebingen

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
•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).
+1 more criteria

Locations (1)

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

Tübingen, Baden-Wurttemberg, Germany

Key Dates

Start Date

June 2, 2023

Primary Completion Date

October 15, 2025

Completion Date

April 17, 2026

Last Updated

December 11, 2024

Enrollment

150

ESTIMATED participants

Conditions

SmokingTibia Fracture

Interventions

Tobacco Heating System (THS)

DEVICE

Smoking abstinence

OTHER

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

Noncombustible Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers

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E-cigarette UseCigarette Smoking+2 more

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Noncombustible Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers

Effects of Smoking on Network Connectivity in Patients With Schizophrenia Symptoms in Scz Patients

The Role of Flavor in the Substitutability of E-cigarettes for Combustible Cigarettes Among Persistent Smokers

Vape Use Among Younger & Older Smokers

A Case Series: TRUMATCH Graft Cage for Segmental Long Bone Defects

Smoking Cessation Before Bronchoscopy or CT-guided Puncture