NCT05859451 Effect of Tobacco Heating System (THS) on Closed Lower Limb Fracture Healing
| NCT ID | NCT05859451 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Tuebingen |
| Condition | Smoking |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-06-02 |
| Primary Completion | 2025-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2023-06-02 with a primary completion date of 2025-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05859451 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Smoking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05859451 currently recruiting?
Yes, NCT05859451 is actively recruiting participants. Contact the research team at andreas.nuessler@med.uni-tuebingen.de for enrollment information.
Where is the NCT05859451 trial being conducted?
This trial is being conducted at Tübingen, Germany.
Who is sponsoring the NCT05859451 clinical trial?
NCT05859451 is sponsored by University Hospital Tuebingen. The trial plans to enroll 150 participants.