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Official title Effect of Tobacco Heating System (THS) on Closed Lower Limb Fracture Healing
ClinicalTrials.gov ID: NCT05859451
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Smokers with 10-20 packyears smoking history.
- Smoking history \>10 years.
- Decision not to participate in the free smoking cessation seminars.
You likely can't join 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.
See the full eligibility 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 for the...
- Smokers with 10-20 packyears smoking history.
- Smoking history \>10 years.
- Decision not to participate in the free smoking cessation seminars.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tübingen, Baden-Wurttemberg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tübingen, Baden-Wurttemberg, Germany. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.