Effect of Tobacco Heating System (THS) on Closed Lower Limb Fracture Healing

University Hospital Tuebingen

Status: Enrolling

Conditions: Tibia Fracture; Smoking

Treatments: Other: Smoking abstinence; Device: Tobacco Heating System (THS)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05859451

IIS.SWI-THS.2022

Details and patient eligibility

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).

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 3 patient groups

Smokers

No Intervention group

Description:

Participants subject to an orthopedic surgery (does not want to quit smoking conventional cigarettes) will continue smoking conventional cigarettes ad libitum for a period of 6 month post surgery

Smokers willing to switch to THS

Experimental group

Description:

Participants subject to an orthopedic surgery (currently smoking conventional cigarettes) will start to used THS ad libitum for a period of 6 month post surgery

Treatment:

Device: Tobacco Heating System (THS)

Ex Smokers

Active Comparator group

Description:

Participants subject to an orthopedic surgery will not smoke cigarettes or use electronic nicotine deliver systems for a period of 6 month post surgery

Treatment:

Other: Smoking abstinence