Comparative Evaluation of External Chest Wall Fixator Treatment Effectiveness in Patients With Rib Fractures
Phase: NA
Conditions: Rib Fractures, Trauma
Sponsor: Ege University

Protocol Name/Code: Comparative Evaluation of External Chest Wall Fixator Treatment 
Effectiveness in Patients With Rib Fractures 
Date/ Version: 11.06.2020 
                      
Protocol Information Form for Non-Pharmaceutical Studies 
Document 
Code 
Rev. Date / Number: 
Page 
Form 16 
03.11.2010/EÜTF00 
1/6 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOL NAME & CODE  
 
 
 
Comparative Evaluation of External Chest Wall Fixator Treatment Effectiveness in Patients With 
Rib Fractures 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Name/Code: Comparative Evaluation of External Chest Wall Fixator Treatment 
Effectiveness in Patients With Rib Fractures 
Date/ Version: 11.06.2020 
                      
Protocol Information Form for Non-Pharmaceutical Studies 
Document 
Code 
Rev. Date / Number: 
Page 
Form 16 
03.11.2010/EÜTF00 
2/6 
  
PRIVACY WARNING 
This document is confidential and cannot be printed or reproduced without the knowledge of the research 
team. 
 
 
 
 
Protocol Name and Code: Comparative Evaluation of External Chest Wall Fixator Treatment 
Effectiveness in Patients With Rib Fractures 
 
 
 
1. SUMMARY OF THE STUDY 
 
Within the scope of the research, an experimental group of 14 people and a control group of 20 
people will be determined. The "Chrisofix External Fixator" fixation orthosis will be applied externally 
to the rib rib-fracture area along with standard medical treatment to the experimental group, and 
standard treatment-medical treatment will be applied to the control group. Within the scope of the 
research, treatment times, difference between initial pain levels and discharge pain levels, and return 
to work times between these groups will be compared. It is expected that the Chrisofix External 
Fixator applied as a result of the project will shorten the treatment time, reduce pain and accelerate 
the return to work process. 
 
 
 
 
 
 
 
2. JUSTIFICATION AND OBJECTIVES OF THE STUDY 
Introduction and Rationale of the Study: 
The aim of the study is to shorten the recovery time in rib fracture cases with external fixation 
treatment, increase comfort, reduce pain level, provide a significant decrease in the time it takes for 
patients to return to daily life, and reduce rib fracture-related complications in patients. 
 
Main Purpose of the Study 
The aim of the study is to shorten the recovery time in rib fracture cases with external fixation 
treatment, increase comfort, reduce pain level, provide a significant decrease in the time it takes for 
patients to return to daily life, and reduce rib fracture-related complications in patients. 
Secondary Purpose of the Study 
 
 
 
3. HYPOTHESIS OF THE STUDY 
1)External fixation reduces the pain level in cases with rib fractures 
2) External fixation shortens the hospital stay in cases with rib fractures 
2) External fixation reduces the development of complications in cases with rib fractures 
 
4. POPULATION TO BE RESEARCHED & SELECTION OF VOLUNTEERS 

Protocol Name/Code: Comparative Evaluation of External Chest Wall Fixator Treatment 
Effectiveness in Patients With Rib Fractures 
Date/ Version: 11.06.2020 
                      
Protocol Information Form for Non-Pharmaceutical Studies 
Document 
Code 
Rev. Date / Number: 
Page 
Form 16 
03.11.2010/EÜTF00 
3/6 
  
Disease Name 
Rib fracture 
Number of Volunteers and 
Characteristics 
                                       Kadın            Erkek            Yaş aralığı 
Sağlıklı                    :             0                0                    - 
Hasta (Hastalığın adı)   :             15              15                 20-50 
Toplam sayı              :             15              15                 20-50 
Regulations Regarding the Participation of Volunteers in the Study 
Volunteers will consist of patients who applied to Ege University Faculty of Medicine Hospital after 
trauma and were admitted to the Thoracic Surgery service and who agreed to participate in the study. 
Criteria for Inclusion in the Study 
 
 
Patients with serial rib fractures after trauma 
 
Patients without extrathoracic pathology 
 
 
Criteria for Exclusion from the Study 
 
 
Patients with less than 3 rib fractures 
 
Patients with extrathoracic injuries 
 
Patients with bilateral rib fractures 
 
Patients with flail chest 
 
Patients with hemothorax or pneumothorax requiring drainage with tube thoracostomy at first 
admission 
 
 
Criteria for Exclusion from the Study and Procedures to be Followed in This Case 
Volunteers can leave the study at any stage of the study. Volunteers who have problems completing any of the 
study steps may be excluded from the study. Follow-up of individuals who withdraw or are excluded from the 
study will continue as should be in routine practice. 
 
 
 
5. STUDY DESIGN & METHOD 
Study Design 
Patients who were admitted due to trauma and had serial rib fractures were evaluated. There were 14 
patients in case group and 20 in control group.  
Details of Working Method 
Standard treatment was applied to the control group. External chest wall fixator was applied to the 
case group in addition to standard treatment. Pain levels of the patients, development of 
complications and duration of hospitalization were recorded. Pain levels of the patients were 
evaluated using the Visual Analogue Scale and the pain level was scored between 0 and 10. 
Defining Transactions During Working Days & Visits 
The patient's pain level will be recorded using the Visual Analogue Pain Scale during visits on the day of admission and 
the day of discharge. 
Randomization Method and Its Importance (if any) 
None 
Blindness Method & Importance (if any) 

Protocol Name/Code: Comparative Evaluation of External Chest Wall Fixator Treatment 
Effectiveness in Patients With Rib Fractures 
Date/ Version: 11.06.2020 
                      
Protocol Information Form for Non-Pharmaceutical Studies 
Document 
Code 
Rev. Date / Number: 
Page 
Form 16 
03.11.2010/EÜTF00 
4/6 
  
None 
Ensuring Patient Compliance 
Patients will be informed by us when they are admitted to the Thoracic Surgery service, they will be asked if they want 
to participate in the study, and if they want to participate, they will have to sign an informed consent form. If the 
patient does not want to participate in the study, he will be hospitalized again and standard medical treatment for rib 
fracture will be applied. 
Materials to be Used & Storage Conditions & Responsibilities 
 
 
6. COLLECTION OF STUDY DATA 
Recording Data/Case Report Forms 
The data of the patients will be recorded with case report forms during the days they stay in the thoracic surgery 
service. 
Interpretation and Reporting Methods 
Visual Analog Scale (VAS) will be used to determine the pain level of the patients. 
Evaluation Criteria 
Number/location of rib fractures 
unclassified incident 
Accident Type 
Pathology accompanying rib fracture 
Pain level on the 10th day 
1st month pain level 
3rd month pain level 
development of complications 
Length of hospital stay 
 
 
7. SURGICAL PROCEDURES (if applicable) 
None 
 
8. PRECAUTIONS & WARNINGS TO ENSURE VOLUNTEER SAFETY 
 
 
9. CONDITIONS WHICH MAY REQUIRE SUSPENSION OF OPERATION 
 
 
10. STATISTICAL PROCEDURES 
Sample Size 
34 
Statistical and Analytical Methods 

Protocol Name/Code: Comparative Evaluation of External Chest Wall Fixator Treatment 
Effectiveness in Patients With Rib Fractures 
Date/ Version: 11.06.2020 
                      
Protocol Information Form for Non-Pharmaceutical Studies 
Document 
Code 
Rev. Date / Number: 
Page 
Form 16 
03.11.2010/EÜTF00 
5/6 
  
For categorical variables in descriptive analyses; number and percentage values for continuous 
variables; Mean, standard deviation, min-max and range values will be presented. 
 
Kolmogorov-Smirnov and Shapiro Wilk tests will be performed to examine compliance with normal 
distribution. Chi-square, Mann Whitney U test and Spearman rank correlation will be used to examine 
the statistical relationship between groups. 
 
Statistical significance level will be determined as p<0.05. 
 
11. ETHICAL AND LEGAL REQUIREMENTS & PROVIDING QUALITY ASSURANCE 
Good Clinical Practices and Good Laboratory Practices & Declaration of Helsinki 
Responsible and assistant researchers will adhere to the principles of the "Declaration of Helsinki" throughout 
the study. The study will be conducted according to the principles outlined in good clinical practice. 
Informing Patients and Informed Volunteer Consent 
Informed consent form was obtained from each patient to be included in the study. 
Ensuring Privacy 
Responsible and co-investigators will keep patient names confidential and protect patients' identities from 
unauthorized persons. Only the name and surname initials of the patients will be written on the case report form. 
Any documentation required to identify the patient will be kept in strict confidence by the researcher. In 
accordance with Good Clinical Practice and legal requirements, the principal investigator will allow the 
appropriate authority(ies) to review patients' files. 
Protocol Changes and Approval of Changes 
Before any changes to the protocol are implemented, approval will be obtained from the local ethics committee 
for any regulations that may affect the safety of patients or the conduct of the study. Situations where the change 
is necessary to eliminate an immediate risk or where the change involves only logistical or administrative 
aspects (e.g. change in Monitor(s), change of telephone number) will be excluded from this scope. 
Informing the Local Ethics Committee 
This protocol will be submitted to the Local Ethics Committee by the principal investigator. Before the study is 
initiated, a document stating the date on which the Local Ethics Committee met and the approval was received 
will be documented and given to the researcher. After obtaining approval from the local ethics committee, any 
changes made to the protocol will be submitted to the Ethics Committee by the researcher in accordance with 
local procedures and regulatory requirements. 
The investigator will report all adverse and serious adverse events to the local ethics committee and will comply 
with any requirements to submit an annual report and any additional local reporting. 
Records Retention and Quality Assurance Measures 
The investigator will maintain adequate and accurate records so that the conduct of the study can be fully 
documented and study data can be subsequently verified. These documents should be classified into two 
separate categories: 1) The investigator's study file and 2) The patient's clinical source documents. The 
investigator's study file includes protocols/amendments, Local Ethics Committee and regulatory authority 
approval and correspondence, a sample informed consent, medication records, personnel CVs and authorization 
documents, and other appropriate documents/correspondence, etc. will be found. Additionally, at the end of the 
study, the investigator will keep the patient data on a CD in human-readable format, including all changes in the 
data, correspondence to resolve questions, and an audit string containing the reasons for the changes, which will 
be stored in the investigator's study file. Patient's clinical source documents (these are usually pre-defined in the 
project to record key efficacy/safety parameters that are independent of the Case report forms) patient 
hospital/clinic records, physician's and nurse's notes, appointment book, original laboratory reports, ECG, EEG, 
X-ray, pathology and special It will include examination reports, signed informed consent forms, consultation 
reports and logbooks. The investigator will retain these two types of documents for at least 15 years after 
completion or discontinuation of the study. After this time period, documents may be destroyed in accordance 
with local regulations. 
Financial and Criminal Liability 

Protocol Name/Code: Comparative Evaluation of External Chest Wall Fixator Treatment 
Effectiveness in Patients With Rib Fractures 
Date/ Version: 11.06.2020 
                      
Protocol Information Form for Non-Pharmaceutical Studies 
Document 
Code 
Rev. Date / Number: 
Page 
Form 16 
03.11.2010/EÜTF00 
6/6 
  
In case of deviation from the protocol of the study, financial and criminal liability belongs to the responsible 
researcher. 
 
12. MONITORING AND SUPERVISING THE WORK 
 
 
13. REFERENCES 
1)Mészáros T., Sárváry A., Petri A., Záborszky Z., Bolla K. Use of Chest Orthosis Can Significantly Shorten the 
Hospitalisation of Rib Fracture Patients. 7th European Trauma Congress. Ljubljana, Slovenia, May 14-17, 
2006;279–82 
2) Lee Y., Lee SH., Kim C., Choi HJ. Comparison of the effectiveness in pain reduction and pulmonary function 
between a rib splint constructed in the ER and a manufactured rib splint. Medicine (Baltimore) 2018 
May;97(21):e10779 
3) Liebsch C., Seiffert T., Vlcek M., Beer M., Huber-Lang M., Wilke HJ. Patterns of serial rib fractures after 
blunt chest trauma: An analysis of 380 cases. PLoS One. 2019 Dec 19;14(12):e0224105. 
4)Sirmali M1, Türüt H, Topçu S, Gülhan E, Yazici U, Kaya S et all. A comprehensive analysis of traumatic rib 
fractures: morbidity, mortality and management. Eur J Cardiothorac Surg. 2003 Jul;24(1):133-8. 
5)Lin FC., Li RY., Tung YW., Jeng KC., Tsai SC. Morbidity, mortality, associated injuries, 
and management of traumatic rib fractures. J Chin Med Assoc. 2016 Jun;79(6):329-34. 
6)Ziegler DW., Agarwal NN. The morbidity and mortality of rib fractures. The Journal of Trauma, 01 Dec 1994, 
37(6):975-979 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date / Signature 
 
RESPONSIBLE RESEARCHER