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

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

This study is testing if switching from regular cigarettes to a tobacco heating system helps smokers heal better from lower limb fractures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital Tuebingen (Academic / other)
• Locations: 1 site (Tübingen, Baden-Wurttemberg)
• Trial ID: NCT05859451 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are smokers with a history of 10-20 pack-years and closed tibia or femur fractures treated surgically within 14 days of injury.

Not a fit: Patients with open fractures, those who have already undergone surgical treatment, or individuals with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into alternative smoking cessation methods that may enhance bone healing in smokers with fractures.

How similar studies have performed: While the specific approach of using a tobacco heating system for fracture healing is novel, previous studies have explored the effects of smoking on bone healing, indicating a potential area for impactful research.

Eligibility criteria

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 this trial is running

Tübingen, Baden-Wurttemberg

• 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.

Conditions Smoking; Tibia Fracture; Bone healing; Tobacco heating system; Smoking cessation