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

Launched by UNIVERSITY HOSPITAL TUEBINGEN · May 4, 2023

Keywords

ClinConnect Summary

This clinical trial is examining how switching from traditional cigarette smoking to a tobacco heating system (THS) affects the healing of closed tibia fractures in smokers. The researchers want to find out if using THS can improve recovery compared to those who have quit smoking altogether. Participants in the study will be orthopedic patients who have had a closed tibia fracture and are either current smokers or have switched from smoking to using THS. The trial will last for six months, and the team will look at various health assessments and feedback from the participants to see how well their bones are healing.

To be eligible for this study, participants need to have a specific type of closed tibia fracture and be smokers with a history of smoking for at least 10 years. Individuals who have recently had surgery for their fracture and are willing to follow the study guidelines can participate, but there are certain exclusions, such as having other serious health conditions or being pregnant. If you join this trial, you'll be contributing to important research that could help improve recovery for smokers with fractures, and you’ll receive regular check-ups during the study to monitor your healing process.

Gender

ALL

Eligibility criteria

• 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).