Effect of Tobacco Heating System (THS) on Closed Lower Limb Fracture Healing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Tuebingen
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Smokers with 10-20 packyears smoking history.
Smoking history >10 years.
Decision not to participate in the free smoking cessation seminars.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Tobacco Heating System (THS)
DeviceParticipant who are not willing to quit cigarette smoking during the study duration will switch from cigarettes to using THS
Smoking abstinence
Other interventionParticipant who are willing to quit cigarette smoking and will not use any electronic nicotine delivery system during the study duration
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: SmokersNo intervention 0 interventions
Group B: Smokers willing to switch to THSExperimental treatment 1 intervention
Group C: Ex SmokersActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Concentration of Procollagen Type 1 N-Terminal Propeptide (CICP)
Marker collagen formation - bone formation
Time frame
6 months after tibia fracture surgerySecondary outcomes
1
Concentration of Alkaline Phosphatase (BAP)
Marker osteoblast activity
Time frame
6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)2
Concentration of Osteoprogesterin
Decoy receptor RANKL - inhibit osteoclast differentiation
Time frame
6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)3
Concentration of Osteopontin
Extracellular structural protein and an organic component of bone - favors osteoclast adherence
Time frame
6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)4
Concentration of N-terminal telopeptide (NTx)
Marker collagen degradation - bone resorption
Time frame
6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)Other outcomes
1
Concentration of Soluble intercellular adhesion molecule-1 (sICAM-1)
Time frame
6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)2
Concentration of High densitiy lipoprotein cholesterol levels (HDL)
Time frame
6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)3
Concentration of Leucocytes
Time frame
6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)4
Concentration of Erythrocytes
Time frame
6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Tuebingen
Lead sponsor
Philip Morris Products S.A.
Collaborator
Source ClinicalTrials.gov