Investigating the impact of a tobacco heating system on healing of lower limb fractures in smokers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate how switching from traditional cigarette smoking to a tobacco heating system affects the healing process of closed lower limb fractures in smokers. The study will involve orthopedic patients with tibia or femur fractures who are either current smokers or have switched to using the tobacco heating system. Over a six-month period, various clinical outcomes will be assessed using standardized assays and self-reported measures, comparing the results with those of ex-smokers. The goal is to determine if the tobacco heating system can improve fracture healing outcomes in this population.

Why it matters

Who can join: the full rules

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).

Where it's running

• Siegfried Weller Institutes, BG-Trauma Clinic, Department of Traumatology, Eberhard Karls University Tübingen
  Tübingen, Baden-Wurttemberg, Germany Recruiting

Study contacts

• Study coordinator: Andreas K. Nüssler, Prof. Dr.
• Email: andreas.nuessler@med.uni-tuebingen.de
• Phone: +49070716061065

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.