Actively Recruiting
Led by University Hospital Tuebingen · Updated on 2024-12-11
150
Participants Needed
1
Research Sites
26 weeks
Total Duration
U
University Hospital Tuebingen
Lead Sponsor
P
Philip Morris Products S.A.
Collaborating Sponsor
Researchers are investigating the effects of switching from conventional cigarette smoking to a tobacco heating system (THS) on the healing outcomes of closed lower limb fractures (tibia and femur) in smokers undergoing orthopedic surgery. The study aims to compare clinical outcomes among smokers continuing cigarette use, smokers switching to THS, and ex-smokers over a six-month period. This research focuses on validated medical assays and patient-reported outcomes to understand how these different smoking behaviors impact fracture healing. Participants are grouped into three categories: those who continue smoking conventional cigarettes without quitting, those who switch to using the THS device freely during the six months after surgery, and those who abstain from both cigarettes and electronic nicotine delivery systems for six months post-surgery. The study involves orthopedic patients who have undergone surgical treatment for their fractures within 14 days of injury. During the six months following surgery, researchers will monitor multiple indicators including bone healing markers like Procollagen Type 1 N-Terminal Propeptide (CICP), bone stiffness via CT scans, functional scores such as the Lower Extremity Functional Scale, pain levels, complication rates, hospital stay duration, and overall quality of life. Assessments occur at various times including before surgery and several points after surgery. This comprehensive monitoring helps evaluate how cigarette smoking and THS use influence bone healing and recovery.
CONDITIONS
Effect of Tobacco Heating System (THS) on Closed Lower Limb Fracture Healing
You may qualify if you...
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days after trauma for surgery
Participants undergo orthopedic surgery to treat their closed lower limb fracture.
1 surgical visit
Duration - 6 months
Participants will either continue smoking conventional cigarettes, switch to Tobacco Heating System (THS), or abstain from smoking for 6 months post surgery.
Multiple visits at approximately one week pre-surgery, six weeks, twelve weeks, and six months post-surgery
Duration - Up to 6 months post surgery
Participants are assessed for fracture healing, bone health, functional recovery, and quality of life after treatment ends.
Visits coincide with treatment visits at approximately one week pre-surgery, six weeks, twelve weeks, and six months post-surgery
Total: 1 location
1
Siegfried Weller Institutes, BG-Trauma Clinic, Department of Traumatology, Eberhard Karls University Tübingen
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
A
Andreas K. Nüssler, Prof. Dr.
B
Benedikt J. Braun, PD. Dr.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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