Back to resultsEffect of Tobacco Heating System (THS) on Closed Tibia Fracture Healing
Primary Purpose
Smoking, Tibia Fracture
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Tobacco Heating System (THS)
Smoking abstinence
Sponsored by
About this trial
This is an interventional prevention trial for Smoking focused on measuring Bone healing, Tobacco heating system, Smoking cessation
Eligibility Criteria
Inclusion Criteria: Closed tibial fracture (according to AO/OTA classification: 41A2-41C3, 42A-C, 43A-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 tibial fractures or concomitant injuries or complications requiring surgery existing at the time of surgical indication. Initial surgical treatment of the tibial 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).
Sites / Locations
- Siegfried Weller Institutes, BG-Trauma Clinic, Department of Traumatology, Eberhard Karls University TübingenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Active Comparator
Arm Label
Smokers
Smokers willing to switch to THS
Ex Smokers
Arm 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
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
Participants subject to an orthopedic surgery will not smoke cigarettes or use electronic nicotine deliver systems for a period of 6 month post surgery
Outcomes
Primary Outcome Measures
Concentration of Procollagen Type 1 N-Terminal Propeptide (CICP)
Marker collagen formation - bone formation
Secondary Outcome Measures
Concentration of Alkaline Phosphatase (BAP)
Marker osteoblast activity
Concentration of Osteoprogesterin
Decoy receptor RANKL - inhibit osteoclast differentiation
Concentration of Osteopontin
Extracellular structural protein and an organic component of bone - favors osteoclast adherence
Concentration of N-terminal telopeptide (NTx)
Marker collagen degradation - bone resorption
Concentration of Interleukin 1 beta (IL-1β)
Concentration of Interleukin 6 (IL-6)
Concentration of Interferon gamma (IFN-γ)
Concentration of Tumor Necrosis Factor Alpha (TNF-α)
Number of bridged cortices in conventional X-ray
Number of bridged cortices in computed tomography scan
Bone Stiffness by a CT-based finite element method
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
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
The time period with no, sole contact, partial or full load on the injured extremity.
Lower Extremity Functional Scale (LEFS) - Score
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
Number of hospital stay and incapacity to work [days]
Physicians Global Assessment to measure quality of life (PROMIS GH10 v 1.2) - Score
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
Visual Analog Scale for Pain (VAS) provide an estimate of patients' pain intensity. Scale from cero (no pain) to 10 (extreme pain).
Full Information
NCT ID
NCT05859451
First Posted
March 30, 2023
Last Updated
May 31, 2023
Sponsor
University Hospital Tuebingen
Collaborators
Philip Morris Products S.A.
1. Study Identification
Unique Protocol Identification Number
NCT05859451
Brief Title
Effect of Tobacco Heating System (THS) on Closed Tibia Fracture Healing
Official Title
Evaluation of Tobacco Heating System (THS) Compared to Conventional Cigarette Smoking During the Closed Tibia Fracture Healing in Orthopedic Smokers' Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Anticipated)
Primary Completion Date
October 15, 2025 (Anticipated)
Study Completion Date
April 17, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen
Collaborators
Philip Morris Products S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 tibia 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Tibia Fracture
Keywords
Bone healing, Tobacco heating system, Smoking cessation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Smokers
Arm Type
No Intervention
Arm 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
Arm Title
Smokers willing to switch to THS
Arm Type
Experimental
Arm 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
Arm Title
Ex Smokers
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
Tobacco Heating System (THS)
Other Intervention Name(s)
IQOS 3 DUO
Intervention Description
Participant who are not willing to quit cigarette smoking during the study duration will switch from cigarettes to using THS
Intervention Type
Other
Intervention Name(s)
Smoking abstinence
Intervention Description
Participant who are willing to quit cigarette smoking and will not use any electronic nicotine delivery system during the study duration
Primary Outcome Measure Information:
Title
Concentration of Procollagen Type 1 N-Terminal Propeptide (CICP)
Description
Marker collagen formation - bone formation
Time Frame
6 months after tibia fracture surgery
Secondary Outcome Measure Information:
Title
Concentration of Alkaline Phosphatase (BAP)
Description
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)
Title
Concentration of Osteoprogesterin
Description
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)
Title
Concentration of Osteopontin
Description
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)
Title
Concentration of N-terminal telopeptide (NTx)
Description
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)
Title
Concentration of Interleukin 1 beta (IL-1β)
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)
Title
Concentration of Interleukin 6 (IL-6)
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)
Title
Concentration of Interferon gamma (IFN-γ)
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)
Title
Concentration of Tumor Necrosis Factor Alpha (TNF-α)
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)
Title
Number of bridged cortices in conventional X-ray
Time Frame
6 months after tibia fracture surgery
Title
Number of bridged cortices in computed tomography scan
Time Frame
6 months after tibia fracture surgery
Title
Bone Stiffness by a CT-based finite element method
Description
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
Time Frame
6 months after tibia fracture surgery
Title
Functional index in trauma (FIX-IT) - Score
Description
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).
Time Frame
6 months after tibia fracture surgery
Title
Loading of the injured extremity
Description
The time period with no, sole contact, partial or full load on the injured extremity.
Time Frame
6 months after tibia fracture surgery
Title
Lower Extremity Functional Scale (LEFS) - Score
Description
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.
Time Frame
6 months after tibia fracture surgery
Title
Number of complications associated with the healing process
Time Frame
6 months after tibia fracture surgery
Title
Number of hospital stay and incapacity to work [days]
Time Frame
6 months after tibia fracture surgery
Title
Physicians Global Assessment to measure quality of life (PROMIS GH10 v 1.2) - Score
Description
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.
Time Frame
6 months after tibia fracture surgery
Title
Visual Analog Score for pain (VAS) - Score
Description
Visual Analog Scale for Pain (VAS) provide an estimate of patients' pain intensity. Scale from cero (no pain) to 10 (extreme pain).
Time Frame
6 months after tibia fracture surgery
Other Pre-specified Outcome Measures:
Title
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)
Title
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)
Title
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)
Title
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)
Title
Concentration of Hemoglobin
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)
Title
Concentration of Thrombocytes
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)
Title
Mean corpuscular volume
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)
Title
Hematocrit levels
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)
Title
Mean corpuscular hemoglobin levels
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)
Title
Corpuscular hemoglobin concentration
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)
Title
Protein c reactive levels
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)
Title
Alcohol consume
Description
Compensation cigarette abstinence with alcohol
Time Frame
6 months after tibia surgery
Title
Questionnaire on Smoking Urges (QSU-G) - Score
Time Frame
6 months after tibia surgery
Title
Smoking behaviour
Description
Number of cigarettes or THS heets consume
Time Frame
6 months after tibia surgery
Title
Nicotine withdrawal syndrome assessment - Checklist
Time Frame
6 months after tibia surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Closed tibial fracture (according to AO/OTA classification: 41A2-41C3, 42A-C, 43A-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 tibial fractures or concomitant injuries or complications requiring surgery existing at the time of surgical indication.
Initial surgical treatment of the tibial 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas K. Nüssler, Prof. Dr.
Phone
+49070716061065
Email
andreas.nuessler@med.uni-tuebingen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Benedikt J. Braun, PD. Dr.
Phone
+49070716063017
Email
bbraun@bgu-tuebingen.de
Facility Information:
Facility Name
Siegfried Weller Institutes, BG-Trauma Clinic, Department of Traumatology, Eberhard Karls University Tübingen
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas K. Nüssler, Prof. Dr.
Phone
+49070716061065
Email
andreas.nuessler@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Benedik J. Braun, PD. Dr. med.
Phone
+49070716063017
Email
bbraun@bgu-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Andreas K. Nüssler, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Benedik J. Braun, PD. Dr. med.
First Name & Middle Initial & Last Name & Degree
Romina H. Aspera-Werz, Dr. sc. hum.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD (in an anonymous form) that underlie results in a publication
IPD Sharing Time Frame
6 months after results are published in peer-reviewed international journal
Citations:
PubMed Identifier
32952862
Citation
Aspera-Werz RH, Ehnert S, Muller M, Zhu S, Chen T, Weng W, Jacoby J, Nussler AK. Assessment of tobacco heating system 2.4 on osteogenic differentiation of mesenchymal stem cells and primary human osteoblasts compared to conventional cigarettes. World J Stem Cells. 2020 Aug 26;12(8):841-856. doi: 10.4252/wjsc.v12.i8.841.
Results Reference
background
PubMed Identifier
36708864
Citation
Weng W, Bovard D, Zanetti F, Ehnert S, Braun B, Uynuk-Ool T, Histing T, Hoeng J, Nussler AK, Aspera-Werz RH. Tobacco heating system has less impact on bone metabolism than cigarette smoke. Food Chem Toxicol. 2023 Mar;173:113637. doi: 10.1016/j.fct.2023.113637. Epub 2023 Jan 25.
Results Reference
background
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Effect of Tobacco Heating System (THS) on Closed Tibia Fracture Healing
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