Actively Recruiting
Effect of Tobacco Heating System (THS) on Closed Lower Limb Fracture Healing
Led by University Hospital Tuebingen · Updated on 2024-12-11
150
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
Sponsors
U
University Hospital Tuebingen
Lead Sponsor
P
Philip Morris Products S.A.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Effect of Tobacco Heating System (THS) on Closed Lower Limb Fracture Healing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Closed tibia or femur fracture surgically treated within 14 days after trauma
- Smokers with a history of 10 to 20 pack-years
- Smoking history longer than 10 years
- Decision not to participate in free smoking cessation seminars
You will not qualify if you...
- Legal guardian or loss of capacity to consent
- Refusal to participate in the study
- Open fractures or other injuries requiring surgery at time of surgery indication
- Initial fracture treatment done outside the study hospital
- No surgery within 14 days after trauma
- Using nicotine delivery electronic devices
- Pre-existing autoimmune, immunological, bone, or malignant diseases
- Pregnant, breastfeeding, or women of childbearing age wanting children
- History of alcohol or drug abuse
- Taking approved antioxidants by German Federal Institute for Drugs and Medical Devices
- Taking drugs affecting bone metabolism as defined by medical guidelines
AI-Screening
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Trial Site Locations
Total: 1 location
1
Siegfried Weller Institutes, BG-Trauma Clinic, Department of Traumatology, Eberhard Karls University Tübingen
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
Research Team
A
Andreas K. Nüssler, Prof. Dr.
CONTACT
B
Benedikt J. Braun, PD. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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