Smoking, Tibia Fracture
Conditions
Keywords
Bone healing, Tobacco heating system, Smoking cessation
Brief summary
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).
Interventions
DEVICETobacco Heating System (THS)
Participant who are not willing to quit cigarette smoking during the study duration will switch from cigarettes to using THS
OTHERSmoking abstinence
Participant who are willing to quit cigarette smoking and will not use any electronic nicotine delivery system during the study duration
Sponsors
Philip Morris Products S.A.
University Hospital Tuebingen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Procollagen Type 1 N-Terminal Propeptide (CICP) | 6 months after tibia fracture surgery | Marker collagen formation - bone formation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Osteopontin | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) | Extracellular structural protein and an organic component of bone - favors osteoclast adherence |
| Concentration of N-terminal telopeptide (NTx) | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) | Marker collagen degradation - bone resorption |
| Concentration of Interleukin 1 beta (IL-1β) | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) | — |
| Concentration of Interleukin 6 (IL-6) | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) | — |
| Concentration of Interferon gamma (IFN-γ) | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) | — |
| Concentration of Tumor Necrosis Factor Alpha (TNF-α) | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) | — |
| Number of bridged cortices in conventional X-ray | 6 months after tibia fracture surgery | — |
| Number of bridged cortices in computed tomography scan | 6 months after tibia fracture surgery | — |
| Bone Stiffness by a CT-based finite element method | 6 months after tibia fracture surgery | Finite element method will be used to simulate the mechanical behavior (linear-elastic range) of the tibia and predict bending stiffness under a 3-point bending test |
| Functional index in trauma (FIX-IT) - Score | 6 months after tibia fracture surgery | Assess weight-bearing and pain in patients with lower extremity fractures eight-bearing and pain in patients with lower extremity fractures. The score rank from 0 to 12 points in 2 domains: the ability to bear weight (maximum 6 points) and pain at the fracture site (maximum 6 points). The scores in both domains, which are weighted equally, are summed to obtain the final total score; (maximum 12 points indicates the highest level of function). |
| Loading of the injured extremity | 6 months after tibia fracture surgery | The time period with no, sole contact, partial or full load on the injured extremity. |
| Lower Extremity Functional Scale (LEFS) - Score | 6 months after tibia fracture surgery | The Lower Extremity Functional Scale (LEFS) is a questionnaire (20 questions) about a person's ability to perform everyday tasks. The LEFS will be used to evaluate the functional impairment of a patient with a disorder of lower extremity. The score rank from 0 to 80 points. The maximum score (80 point) indicates no functional limitations. |
| Number of complications associated with the healing process | 6 months after tibia fracture surgery | — |
| Number of hospital stay and incapacity to work [days] | 6 months after tibia fracture surgery | — |
| Physicians Global Assessment to measure quality of life (PROMIS GH10 v 1.2) - Score | 6 months after tibia fracture surgery | The Global Health Patient-Reported Outcomes Measurement Information System (PROMIS- 10) scale is a ten-item patient reported measure of physical, mental and social health. Two summary scores are calculated from the results of the questions: a global physical health score and a global mental health score. These scores are then normalized to the general population using the T-score. The score ranges from 0 to 20 points. 0 points represent the most severe physical and/or mental impairment of the patient, while 20 points represent the best possible health status. |
| Visual Analog Score for pain (VAS) - Score | 6 months after tibia fracture surgery | Visual Analog Scale for Pain (VAS) provide an estimate of patients' pain intensity. Scale from cero (no pain) to 10 (extreme pain). |
| Concentration of Alkaline Phosphatase (BAP) | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) | Marker osteoblast activity |
| Concentration of Osteoprogesterin | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) | Decoy receptor RANKL - inhibit osteoclast differentiation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Leucocytes | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) | — |
| Concentration of Erythrocytes | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) | — |
| Concentration of Hemoglobin | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) | — |
| Concentration of Thrombocytes | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) | — |
| Mean corpuscular volume | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) | — |
| Hematocrit levels | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) | — |
| Mean corpuscular hemoglobin levels | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) | — |
| Corpuscular hemoglobin concentration | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) | — |
| Protein c reactive levels | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) | — |
| Alcohol consume | 6 months after tibia surgery | Compensation cigarette abstinence with alcohol |
| Questionnaire on Smoking Urges (QSU-G) - Score | 6 months after tibia surgery | — |
| Smoking behaviour | 6 months after tibia surgery | Number of cigarettes or THS heets consume |
| Nicotine withdrawal syndrome assessment - Checklist | 6 months after tibia surgery | — |
| Concentration of Soluble intercellular adhesion molecule-1 (sICAM-1) | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) | — |
| Concentration of High densitiy lipoprotein cholesterol levels (HDL) | 6 months after tibia fracture surgery (time points: approx. one week pre-, six weeks post-, twelve weeks post- and six months post-surgery) | — |
Countries
Germany
Contacts
Primary ContactAndreas K. Nüssler, Prof. Dr.
Backup ContactBenedikt J. Braun, PD. Dr.
Outcome results
None listed