Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial Plateau Fractures
Phase: NA
Conditions: Arthroscopy, Tibial Fractures, Orthopedic, Fracture Fixation
Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Project name:Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial 
Plateau Fractures 
 
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Project name： 
Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV 
Tibial Plateau Fractures 
Clinical trial protocol 
 
 
 
Project number：SAHoWMU-CR2017-08-105 
ClinicalTrials.gov Identifier：NCT03327337 
Version number：1.1 
Version date：2017.09.01 
   
 
 
Responsible unit： 
Second Affiliated Hospital of Wenzhou Medical University 
 
Clinical researcher: You-ming Zhao 
Confidentiality statement: This document contains important confidential information, which 
belongs to the Second Affiliated Hospital of Wenzhou Medical University. Unless it is required by 
the existing laws and regulations, it is not allowed to be public. In any case, the confidentiality 
requirement shall be communicated to all persons who have received the information, and no further 
disclosure of this information shall be made. This open limit applies equally to all documents that 
will be provided and confidential in the future.

Project name:Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial 
Plateau Fractures 
 
                                                                                       Version number 1.1 
 
 
Project signature page 
Signature of the Sponsor: I've read and confirmed this Project (Project number ：     
SAHoWMU-CR2017-08-105      ；Version number： 1.1   ；Version date：    2017.09.01     ).I 
agree to perform relevant duties in accordance with Chinese law, the Helsinki declaration, China's 
GCP and the research program. 
 
 
 
 
 
Responsible Unit： 
Second Affiliated Hospital of Wenzhou Medical University 
 
 
 
 
 
李挺刘进 
 
 
Sponsor (Printed matter) 
Sponsor (autograph) 
Signature date (year / 
month / day) 
 

Project name:Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial 
Plateau Fractures 
 
                                                                                       Version number 1.1 
 
Project signature page 
Signature of researcher: I've read and confirmed this Project (Project number ：     
SAHoWMU-CR2017-08-105      ；Version number： 1.1   ；Version date：    2017.09.01     ). And 
agree that this project is scientific and ethical. We will perform related duties in accordance with the 
law, the Helsinki declaration, Chinese China GCP and the research program, and only in the bid after 
the notice to amend, approved by the ethics committee before implementation, unless for the 
protection of the safety of subjects, rights and interests and must take measures. 
We will keep the research plan confidential. 
 
Researcher: trauma department of orthopedics Second Affiliated Hospital of Wenzhou 
Medical University 
 
 
 
 
 
刘赵赵友明明进 
 
 
Researcher (Printed matter) 
Researcher (autograph) 
Signature date (year / 
month / day) 
 
 

Project name:Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial 
Plateau Fractures 
 
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Catalog 
Abbreviation...................................................................................................................1 
Project abstract ...............................................................................................................2 
Technology Roadmap .....................................................................................................1 
Project  text ...................................................................................................................2 
1. 
Research topics ............................................................................................................. 2 
2. 
Research background .................................................................................................. 2 
3. 
Test purpose and design basis ..................................................................................... 3 
3.1Purpose ......................................................................................................................................... 3 
3.2 Research overall design ............................................................................................................... 3 
3.3Sample size ................................................................................................................................... 3 
3.4Study patients ............................................................................................................................... 3 
4. 
Research subjects ......................................................................................................... 3 
4.1 
inclusion criteria ..................................................................................................................... 3 
4.2 
Exclusion criteria ................................................................................................................... 4 
4.3 Exit criteria .................................................................................................................................. 4 
5. 
Project  design ............................................................................................................ 4 
5.1 Project process............................................................................................................................. 4 
5.2 Screening period (from admission to day before surgery) .......................................................... 5 
5.3 During the study period (from the day of surgery to 1 years after surgery) ................................ 5 
5.4 The end of the study period (the end of the follow-up to the project end) .................................. 6 
6. 
Efficacy evaluation index ............................................................................................ 6 
7. 
Safety evaluation .......................................................................................................... 7 
7.1 Adverse event definition .............................................................................................................. 7 
7.2 Ways of getting information about adverse events ...................................................................... 7 
7.3 Record of adverse events ............................................................................................................. 7 

Project name:Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial 
Plateau Fractures 
 
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7.4 Criteria for severity of adverse events ......................................................................................... 7 
7.5 The judgment standard of adverse events and test operation relations ........................................ 8 
7.6 Important adverse events ............................................................................................................. 8 
7.7 Plans to deal with cases of serious adverse events ...................................................................... 8 
8. 
Statistical analysis ........................................................................................................ 9 
8.1 Data selection for statistical analysis ........................................................................................... 9 
8.2 Statistical analysis plan ............................................................................................................... 9 
9. 
Data management and statistical analysis ............................................................... 10 
9.1 Filling and transferring of case report form ............................................................................... 10 
9.2 Data input and modification ...................................................................................................... 10 
9.3 Data locking .............................................................................................................................. 10 
10. 
Amendment of project ............................................................................................... 10 
11. 
GCP principle - the rights and safety of subjects .................................................... 10 
12. 
The responsibilities of researchers ........................................................................... 11 
13. 
Project  schedule ...................................................................................................... 11 
14. 
References ................................................................................................................... 12 
15. 
Appendix I    Clinical trial flow chart .................................................................. 13 

Project name:Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial 
Plateau Fractures 
 
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Abbreviation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ALT 
Glutamate aminotransferase 
APTT 
Activated partial thromboplastin time 
AST 
Aspartate aminotransferase 
BLD 
Urine red blood cell 
BP 
blood pressure 
BUN 
Urea nitrogen 
Cr 
creatinine 
CRF 
Case report form 
FBG 
Fasting plasma glucose 
FIB 
Fibrinogen 
GCP 
Specification for quality management of drug clinical trials 
Hb 
hemoglobin 
HCT 
Hematocrit 
HR 
heart rate 
INR 
International normalized value 
LEU 
The number of white blood cell 
NEUT 
Neutrophils 
PLT 
Platelet 
PRO 
Urine protein 
PT 
prothrombin time 
RBC 
Red blood cell 
TT 
Thrombin time 
UA 
uric acid 
U-GLU 
urine sugar 
Urea 
urea 
VAS 
Visual analogue score 
WBC 
white blood cell 

Project name:Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial 
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Project abstract 
Research 
topics     
Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV 
Tibial Plateau Fractures 
purpose 
Objective to compare the clinical diagnosis and treatment of open reduction and 
internal fixation with Schatzker II-IV tibial plateau fracture or arthroscopic 
assisted balloon tibioplasty of tibial plateau fractures. 
overall 
design 
This study used a randomized controlled trial design research. 
diagnostic 
criteria 
At least 2 fixed researchers by X-ray or CT examination to determine fracture 
type 
Screening 
criteria 
Inclusion criteria: The following criteria must be according with. 
(1) fresh closed fracture, X-ray and CT examination diagnosed Schatzker type 
II-IV tibial plateau fracture patients 
(2) sign the informed consent form  
(3) age from 18 to 80 years 
 
Exclusion criteria:  
(1) exclude 
open 
fractures, 
pathological 
fractures, 
immunodeficiency, 
hematological diseases and severe hepatorenal disorders 
(2) refuse to sign informed consent form  
 
 
 

Project name:Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial 
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Methods 
Experimental group: 
patients were randomly divided into the experimental group and 
underwent Arthroscopic Assisted Balloon Tibioplasty. 
Control group: 
patients were randomly divided into control group and underwent Open 
Reduction and Internal Fixation(ORIF). 
 
Curative 
effect 
observation 
index 
Primary Outcome Measure: 
1.Rasmussen scores change after surgery 
the knee joint Rasmussen scores change after surgery 
[Time Frame: 1、2、3、4、6、12mouth Rasmussen scores change after 
surgery] 
Secondary Outcome Measures: 
1.Intraoperative blood loss 
blood loss in surgery 
[Time Frame: Operation day] 
2.Postoperative pain score 
Postoperative pain score(Visual Analogue score，range of scores from 0 
to 10,the score is designed to measure the level of the pain and the higher 
score is,the more painful the patient is) 
[Time Frame: from operation day to leave hospital day(up to 2 weeks)] 
3.Fracture healing time 
Fracture healing time 
[Time Frame: from leave hospital day to healing time(up to 1 year)] 
4.The percentage of joint area recovered after operation was 

Project name:Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial 
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satisfactory 
The percentage of joint area recovered after operation was satisfactory 
[Time Frame: 1、2、3、4、6、12 mouth after surgery] 
5.operation time 
Duration of surgery 
[Time Frame: Operation day] 
6.the postoperative hospital stay days 
the total hospital stay days after surgery 
[Time Frame: from operation day to Leave hospital day(up to 4 weeks)]  
Safety 
observation 
index 
Intraoperative vital signs, Intraoperative C arm examination, postoperative 
examination etc. 
Visiting 
point 
Screening / baseline: admission to the preoperative / postoperative day from the 
first day to the day of discharge. 
1、2、3、4、6、12 mouths after the operation. 
 
statistical 
analysis 
Spss22.0 software was used for statistical analysis. 
The measurement data in SX, using t test, count data expressed as a percentage, 
using X - test, P < 0.05, the difference has statistical significance, and draw the 
relevant charts with RevMan software. Case characteristics and efficacy analysis 
were analyzed by complete analysis set (FAS) and compliance program set 
(PPS), and safety evaluation was analyzed by safety set (SS). 
sample size 
A total of 40 patients were included this project, the experimental group 20 cases 
and the control group 20 cases. 
Research 
cycle 
 July 2017 ~ June 2020 

Project name:Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial 
Plateau Fractures 
 
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Technology Roadmap 
 
 
 

Project name:Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial 
Plateau Fractures 
 
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Project  text 
1. Research topics 
Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial Plateau 
Fractures   
2. Research background 
Tibial plateau fractures account for 1-2% of all fractures, including 8% of the elderly. In recent 
years, the incidence of accidents such as traffic accidents and high falls has increased the incidence 
of tibial plateau fractures. The traditional internal fixation treatment has a series of demerits such as 
too much damage,the limited explosion of articular cavity,the insufficient diagnosis and treatment for 
the internal joint injury and the postoperative complications such as the infection of incisional wound 
and joint degeneration. In recent years, with the development of technology, the treatment concept of 
tibial plateau fractures has developed from original mechanical fixation to present biomechanical 
fixation and minimally invasive surgical direction, namely developed from the absolute anatomic 
reduction and fixation, fracture mechanics healing fixed to minimally invasive operation, indirect 
reduction and elastic fixation, indirect fracture healing (callus healing). Such as MIPPO technology 
represented by the LISS system,arthroscopic assisted reduction and internal fixation technology, as 
well as recently suggested balloon dilation tibioplasty (Balloon Tibioplasty) and other surgical 
techniques. The key of the Schatzker II-IV type of tibial plateau fracture treatment is to the medial 
and lateral tibial plateau collapse of the articular surface reduction, arthroscopically assisted balloon 
distension tibial plasty as an emerging technology, which aims to arthroscopy assisted by the ball 
Capsule expansion tibial angioplasty, reduction of the collapse of the articular surface, and according 
to the patient's specific injury to be plate fixation, the technology has shown its initial collapse of the 
articular surface reduction accuracy, and its surgical trauma is small, postoperative better functional 
recovery of the joint and early functional exercise of the patient. However, the short occurrence time, 
the high cost of operation, the unripe surgical technique and the lack of clinical promotion have also 
been reported in the literature both at home and abroad. Postoperative leakage of bone cement and 
fractures lost patients reset, the lack of long-term follow-up, and no large number of case data, the 
clinical treatment remains to be further observed and studied. 

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3. Test purpose and design basis 
3.1Purpose 
Based on the current data of arthroscopically assisted balloon expansion tibial 
angioplasty, we designed the subject.1. For the patients who met the inclusion criteria, we 
randomly performed Open Reduction and Internal Fixation or Arthroscopically assisted 
balloon expansion tibia. Surgical follow-up, statistical evaluation of the two techniques after 
surgery for the tibial plateau joint resection and joint function recovery clinical efficacy 
difference. 2. Through the clinical practice and experience summary, found that the new 
technology in the operation of the deficiencies in order to improve the technology. 3 through 
the results of feedback and analysis to guide the clinical diagnosis and treatment. 
3.2 Research overall design 
The use of existing resources in our hospital to carry out this new technology for 
patients who meet the inclusion criteria, randomized performed traditional Open Reduction and 
Internal Fixation or Arthroscopically assisted balloon distension tibial angioplasty, access to a certain 
period of time the corresponding patient raw data, through professional statistics and epidemiological 
analysis of comparative data, analysis and discussion based on the analysis results and experience. 
Concluded the postoperative tibial plateau joint surface resection and joint function recovery clinical 
efficacy difference between the Balloon Tibioplasty and traditional Open Reduction and Internal 
Fixation, and the results of feedback to guide the clinical diagnosis and treatment. . 
3.3Sample size 
A total of 40 patients were included this project, the experimental group 20 cases and the 
control group 20 cases. 
 
3.4Study patients 
   Outpatient and emergency patients in trauma department of orthopedics of our hospital. 
4. Research subjects 
4.1 inclusion criteria 
(1) fresh closed fracture X-ray and CT examination diagnosed Schatzker type II-IV tibial 
plateau fracture patients 
(2) sign the informed consent form  

Project name:Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial 
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(3) age from 18 to 80 years 
4.2 Exclusion criteria 
(1) excluding open fractures, pathological fractures, immunodeficiency, hematological diseases 
and severe hepatorenal disorders 
(2) refusing to sign informed consent form  
4.3 Exit criteria 
The patients were lost, half-way to quit and other unpredictable problems 
5. Project  design 
5.1 Project process 
A randomized controlled trial design study using the research methods： 
1) After signed the informed consent, a complete medical history, vital signs and detailed 
physical examination were performed, and patients who met the inclusion criteria who did not meet 
the exclusion criteria were randomly assigned to study. 
2) Patients were enrolled and randomized into groups. The arthroscopically assisted balloon 
expandable tibial plateau in the experimental group and the control group were treated by traditional  
Open Reduction and Internal Fixation. 
3) Experiment group: preoperative preparation: patients with continuous epidural anesthesia, supine, 
conventional arthroscopic approach to the patient's joint cavity to carefully check the articular cavity 
hemorrhage removed, explored the meniscus and before and after cruciate ligament and collateral 
ligament. If there is damage, try to repair first. Step 1: If there is splitting of the tibial plateau, then 
make an incision in the appropriate part of the proximal tibia according to the fracture type and make 
a small knee transverse incision in the proximal end of the incision. The first use of minimally 
invasive surgical techniques in the surgical incision site to place the appropriate specifications of the 
locking support plate, the bottom of the plate screw holes pre-placed in a temporary cortical bone 
screw plate can be used in the expansion of the balloon as the outer cortex support structure, 
prevention of cortical rupture. The temporary fixation of cortical bone screws allow the latter to 
adjust the height of the plate as needed, and place two Kirschner wires on the anterior and posterior 
sides of the lower part of the collapsed platform to obstruct preparation for subsequent surgical 
procedures.  Step 2:C arm fluoroscopy positioning and placement of 3 Kirschner wires, the plane 
formation was located at the center of the platform collapse position below the support point, as 

Project name:Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial 
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balloon dilatation, select the appropriate balloon needle angle, guided by fluoroscopy, placed in the 
center of the balloon platform collapse, so that it is in the best position, filling device of bone cement 
injected with bone cement after expansion, at the same time the use of arthroscopy intervention on 
the articular surface, prevent the reduction of the articular surface is not complete, not smooth or 
excessive. Then Insert the other screws, suture the incision. If the tibial plateau does not splitting, the 
procedure should be carried out directly, and the collapsed articular surface of the tibial plateau can 
be restored directly.(step 2). A detailed record of 20 case of the operation time (min), the amount of 
bleeding(ml), postoperative pain score (visual analogue score (VAS)), the postoperative knee joint 
space width (mm), hospitalization time after operation (d), fracture healing time after operation (m), 
postoperative maximum articular surface collapse height (mm), the percentage of the restoration of 
joint collapse area (%),the knee joint Rasmussen scores change after surgery (Rasmussen score), 
failure rate and complications. 
4）Control group: under the condition of random grouping, the patients in the control group were 
treated with traditional Open Reduction and Internal Fixation of the tibial plateau fracture. A detailed 
record of 20 case of the operation time (min), the amount of bleeding(ml), postoperative pain score 
(visual analogue score (VAS)), the postoperative knee joint space width (mm), hospitalization time 
after operation (d), fracture healing time after operation (m), postoperative maximum articular 
surface collapse height (mm), the percentage of the restoration of joint collapse area (%),the knee 
joint Rasmussen scores change after surgery (Rasmussen score), failure rate and complications. 
5.2 Screening period (from admission to day before surgery) 
1)come to our hospital after injury, meet the inclusion criteria.  
2) at least 2 permanent investigators confirm the type of fracture by X-ray or CT examination. 
3) after signed the informed consent form, according to random table method, the patients were 
randomly divided into experimental group or control group for corresponding treatment. 
5.3 During the study period (from the day of surgery to 1 years after surgery) 
1) the day of surgery recorded in detail the surgical procedures, operation time, intraoperative blood 
loss were recorded. 
2) from operation day to leave hospital day(up to 2 weeks),the postoperative pain score, 
postoperative knee gap width, postoperative hospital stay days were recorded. 
3) the patients were followed up after leave hospital: make a detailed record of the knee joint 
Rasmussen scores change after surgery (Rasmussen score) (1,2,3,4,6,12 months after surgery), The 

Project name:Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial 
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percentage of joint area recovered after operation where was satisfactory, postoperative fracture 
healing time, maximal postoperative articular surface collapse height, postoperative failure rate and 
related complications. 
  
5.4 The end of the study period (the end of the follow-up to the project end) 
1. sort the appropriate information, through epidemiological or statistical experts guidance, 
experimental group and control group data analysis, using SPSS 22.0 statistical software analysis, 
measurement data to sx, using t test, counting data Percentage, using χ² test, P <0.05 for the 
difference was statistically significant, and use RevMan software to draw the relevant charts. 
2. based on the data and charts after treatment, organize clinical discussions and experience of 
relevant personnel: 1.the actual operation of the new technology found in all aspects of the existing 
shortcomings and explore ways to improve the arthroscopic balloon dilatation tibial angioplasty, and 
improve the clinical diagnosis and treatment of fractures related to our hospital level. 2 through get 
the follow-up data under this new technology to enrich our hospital clinical data resources. 
3 According to the results of the comparison, comparative analysis of Arthroscopic Assisted Balloon 
Tibioplasty and traditional Open Reduction and Internal Fixation for reduction of articular surface of 
tibial plateau and joint function recovery clinical curative effect, to guide the clinical work, and 
output clinical practical guidance and industry recognized research results for clinical 
decision-making and diagnosis and treatment guidelines provide a scientific basis. 
 
 
6. Efficacy evaluation index 
6.1The main efficacy indicators 
Operation time (min) 
Postoperative hospital stay (d) (first day after surgery to discharge day, up to 4 weeks) 
Postoperative knee function Rasmussen score changes (1, 2, 3, 4, 6, 12 mouths) 
 
6.2 secondary efficacy indicators 
Intraoperative bleeding (ml) 
Postoperative pain score (visual analogue scale (VAS)) (first postoperative day to discharge day, 
maximum 2 weeks) 

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Postoperative fracture healing time (m) (discharged to fracture healing, maximum 1 year) 
Postoperative knee gap width (mm) 
Postoperative articular surface maximum collapse height (mm) 
Height of well-resumed postoperative articular area as a percentage of collapse area (%) 
7. Safety evaluation 
7.1 Adverse event definition 
Since the patients signed informed consent to the completion of all visits, the patients to report 
or research physician observed any adverse medical events, regardless of whether there is a 
causal relationship with the test drugs, were convicted of adverse events. Adverse events 
included general adverse events, adverse events and serious adverse events. 
7.2 Ways of getting information about adverse events 
All the adverse events report in directly medical terminology report. 
7.3 Record of adverse events 
Record the occurrence of adverse events, severity, duration, and outcome measures. Adverse 
events should be recorded in the specified CRF adverse event reporting table. 
When the adverse events appear, the researcher should immediately report to the responsible 
party and determine the necessary diagnosis and treatment according to the condition of the patient 
to decide whether to stop the clinical trial. All adverse events should be followed up, and the 
treatment process and results should be carefully recorded until the proper solution or the condition 
is stable, and the correlation between the method and the test method is determined. If associated 
with surgery, should be tracked to return to preoperative levels. Follow up visits can be done 
according to the severity of adverse events such as hospitalization, outpatient visits, home visits, 
telephone calls, communication, etc.. 
7.4 Criteria for severity of adverse events 
When completing the CRF adverse event table, the researchers referred to the CTCAE4.0 
criteria to describe the intensity of adverse events using mild, moderate, severe, life-threatening, and 
fatal events. For a unified standard, classification of event intensity of light moderate and severe 
criteria are as follows: 
Mild: does not affect the normal function of patients; 
Moderate:to a certain extent affect the normal function of patients; 
Severe: normal function of affected patients. 

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Pay attention to the difference of adverse events and severity of strength. Used to describe the 
severe intensity, not necessarily SAE. For example, headache may be severe in intensity, but not in 
SAE unless it meets SAE criteria. 
7.5 The judgment standard of adverse events and test operation relations 
Evaluation according to the following interpretation. 
It was confirmed that the adverse events were accorded with the reasonable time after the trial 
operation, and the reaction accorded with the type of reaction known in the test operation; 
It is likely that the adverse events are accorded with the reasonable time after the trial operation, 
that the response conforms to the type of reaction known to the test operation, and that there is 
unlikely to be additional explanation, such as concomitant medication or concomitant disease; 
It may be related to the occurrence of adverse events that are consistent with the time order of 
the trial operation, the response to the type of reaction known to the test operation, and the patient's 
clinical status or other treatment modalities may also reaction of operation; 
It may be irrelevant: adverse events do not conform to the reasonable time sequence after the 
trial operation, and the reaction is not in line with the known type of reaction in the test operation; it 
is more likely to be related to other factors; 
Certainly nothing: the reaction does not comply with the time sequence test operation after 
reasonable, a type of reaction with non test operation known reaction; the patient's clinical status or 
other treatment may cause the reaction, improve the disease state or stop the elimination reaction of 
other treatments, the repeated use of other treatment response. 
Certainly, adverse reactions may be associated and may be related to all adverse events. 
7.6 Important adverse events 
Serious adverse events (SAE) that required hospitalization, prolonged hospitalization, disability, 
affecting work ability, endanger life or death, resulting in congenital malformation occurred during 
the clinical trial. 
7.7 Plans to deal with cases of serious adverse events 
When serious adverse events occur, we should do our best to save them and take all kinds 
of measures to avoid permanent damage. From the beginning of project to any SAE appear in 
the observation period, the researchers shall immediately notify the person in charge of project 
in our hospital, clinical trial management, ethics committee, fill out the "serious adverse 
events", 24h in a written report to the applicant, our hospital clinical trial management 

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departments, the ethics Committee and relevant drug management department. Serious 
adverse events in the end of treatment, the patients should be submitted to the follow-up report 
 
 
 Contacts for serious adverse events 
unit 
linkman 
contact way 
Project Leader 
You-ming Zhao 
13806691852 
ymzhao710@163.com 
The Second Affiliated Hospital 
of Wenzhou Medical University 
Medical ethics 
committee 
0577-88002560 
feykjkcy@126.com 
The Second Affiliated Hospital 
of Wenzhou Medical University 
The clinical research 
center for drug clinical 
trial institution Office 
0577-88002664、88002738 
ywlcsy409@163.com 
 
8. Statistical analysis 
8.1 Data selection for statistical analysis 
Totally analyzed data sets (FAS): all randomized, grouped, and postoperative studies were 
performed with a complete analysis set. For the therapeutic data that failed to be observed in all 
treatments, the final measured efficacy data was used as end point data for analysis. 
PPS (PPS): contained in the FAS, met the inclusion criteria, does not meet the exclusion criteria, no 
major protocol violations, and has completed the treatment period of efficacy evaluation, good 
compliance cases, this study constitutes with the scheme set. 
Safety analysis data set (SS): all patients who were randomized to receive research methods and had 
postoperative safety evaluation data constituted the safety analysis data set of this study. 
8.2 Statistical analysis plan 
There was no significant difference in age, gender, fracture type and other aspects between the two 
groups (P>0.05). Through epidemiological or statistical expert guidance, the experimental group and 
the control group data were analyzed using SPSS 22 statistical software, the measurement data in SX, 
using t test, count data expressed as a percentage, using X - test, P < 0.05, the difference has 
statistical significance, and draw the relevant charts with RevMan software. 
 

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9. Data management and statistical analysis 
9.1 Filling and transferring of case report form 
The case report form (CRF) was filled out by the researchers. The data in CRF were derived 
from original records and physical and chemical examination reports and other original documents 
and should be consistent with the original documents. Any observation and examination result in the 
test should be completed in time, correctly, completely, clearly, standard and truly in CRF, and 
should not be changed at will. All the items in the CRF are required to fill in, not empty or missed. If 
necessary, CRF data correction, fill in the data modification  
9.2 Data input and modification 
Data entry and management by the responsible investigators. Using EDC data entry system to 
establish a dedicated database for data entry and management, in order to ensure the accuracy of data, 
by two data managers independently double input and proofreading. The data entry process any data 
modification system are recorded. 
The existence of the case report form questions, the data administrator will produce FAQ table 
(DRQ), and the issue of asking researchers by CRA, researchers should answer as soon as possible 
and return data, modify, and confirm the administrator for data entry on the answer, when necessary, 
can be re issued DRQ. 
9.3 Data locking 
By the principal investigators, sponsors, statistical analysis of data locking. The locked data file 
is no longer changed. The data after the database lock should be saved for reference, and the database 
will be sent to statistical experts for statistical analysis. 
10. Amendment of project 
Any necessary changes in the project must be carried out in the form of a revised project, which 
should be signed by the principal investigator and submitted to the Ethics Committee for approval or 
filing. 
11. GCP principle - the rights and safety of subjects 
1. the plan must be approved by the Second Affiliated Hospital of Wenzhou medical university 
ethics committee. 
2. all patients should understand the purpose, method, function and advantages and disadvantages of 
the test method, voluntarily participate in the test and sign the written informed consent. 
3. patients had the right of informed consent, and they could quit the experiment according to their 
wishes without affecting their normal medical treatment. 

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4. patients had adverse events related to trials during the trial, and the team was responsible for 
providing treatment costs or corresponding compensation for adverse events related to the trial. 
5. the responsible party should ensure the normal operation of the medical monitoring system, the 
patients can contact with the research doctor at any time needed to obtain timely medical treatment, 
and if necessary, they can be hospitalized for diagnosis and treatment. 
6. emphasize the responsibility of the medical staff at all levels, close observation to ensure patient’s 
safety. 
7. if the adverse events occurred, the patients should be treated in timely, and the patients were 
followed up until the adverse events were cured and the outcome was stable. The researchers thought 
that it was no longer clinically significant or that the subjects were lost to follow-up. 
8. if serious adverse events occur, the necessary measures should be taken to ensure the safety and 
rights of the patients, and they shall be reported to the ethics committee and clinical research center 
of the Second Affiliated Hospital of Wenzhou Medical University within 24 hours. 
9. the informed consent accords with the latest revised version of the Helsinki declaration, as well as 
any applicable provisions and policies. Each participant or his legal representative must have a 
comprehensive understanding of the test and sign his name and date on the informed consent to 
express his consent. 
12. The responsibilities of researchers 
The main investigator and participant should carry out the test according to the clinical research 
plan and abide by the Helsinki declaration, the relevant laws and regulations of China and the current 
GCP principle. 
13. Project  schedule 
2017.7-2019.6: corresponding operation was performed on the experimental group and the control 
group. The patients were followed up for 1,2,3,4,6,12 months after the operation. The X-ray and CT 
examination of the corresponding parts was performed, and the corresponding data were collected. 
2019.7-2019.12: according to the existing problems in the operation, the improvement program was 
put forward, and the relevant feedback data were implemented after improvement. 
2020.1-2020.6: statistical analysis, experience summary and the relevant papers published. 

Project name:Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial 
Plateau Fractures 
 
                                                                                       Version number 1.1 
12 
14. References 
[1] Doria C, Balsano M, Spiga M, et al. Tibioplasty, a new technique in the management of tibial 
plateau fracture: A multicentric experience review[J]. J Orthop, 2017, 14(1): 176-181. 
[2] Ollivier M, Turati M, Munier M, et al. Balloon tibioplasty for reduction of depressed tibial 
plateau fractures: Preliminary radiographic and clinical results[J]. Int Orthop, 2016, 40(9): 1961-6. 
[3] Ziogas K, Tourvas E, Galanakis I, et al. Arthroscopy Assisted Balloon Osteoplasty of a Tibia 
Plateau Depression Fracture: A Case Report[J]. N Am J Med Sci, 2015, 7(9): 411-4. 
[4] Mayr R, Attal R, Zwierzina M, et al. Effect of additional fixation in tibial plateau impression 
fractures treated with balloon reduction and cement augmentation[J]. Clin Biomech (Bristol, Avon), 
2015, 30(8): 847-51. 
[5] Jentzsch T, Fritz Y, Veit-Haibach P, et al. Osseous vitality in single photon emission 
computed tomography/computed tomography (SPECT/CT) after balloon tibioplasty of the tibial 
plateau: a case series[J]. BMC Med Imaging, 2015, 15: 56. 
[6] Mauffrey C, Roberts G, Cuellar D O, et al. Balloon tibioplasty: pearls and pitfalls[J]. J Knee 
Surg, 2014, 27(1): 31-7. 
[7] Craiovan B S, Keshmiri A, Springorum R, et al. [Minimally invasive treatment of depression 
fractures of the tibial plateau using balloon repositioning and tibioplasty: video article][J]. Orthopade, 
2014, 43(10): 930-3. 
[8] Pizanis A, Garcia P, Pohlemann T, et al. Balloon tibioplasty: a useful tool for reduction of 
tibial plateau depression fractures[J]. J Orthop Trauma, 2012, 26(7): e88-93. 
[9] Wang Yukai, Luo Feng, Zhai Qilin. Treatment of articular surface collapse of tibial plateau 
fracture [J]. International Journal of bone science, 2014, (03): 147-150. 
[10] Ceng Guangxuan, Zhu Daoxin, Zhou Jianguo. Clinical application of balloon angioplasty 
under arthroscopy for tibial plateau fractures [J]. Chinese medical innovation, 2014, (05): 14-16. 
[11] Zou Huazhang, Ma Xiaochun, Tang Cheng, et al. composite injectable calcium phosphate 
cement in tibial plateau fractures: [J]. Chinese Journal of reconstruction and reconstructive 
surgery, 2013, (07): 855-859. 
[12] Shiyan, Cui Wengang, Xiao Gang. New progress in surgical treatment of tibial plateau 
fractures [J]. International Journal of bone science, 2013, (03): 174-177. 
[13] Chu Xiaofeng, Ruan Hongjiang, Yao Shuye. Arthroscopic assisted minimally invasive 
surgical treatment of tibial plateau fracture [J]. Chinese Orthopedic Journal, 2012, (04): 374-375. 
 

Project name:Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial Plateau Fractures 
13 
Version number: version 1.1 date: 2017-09-01 
15. Appendix I    Clinical trial flow chart 
content 
Screening 
period 1 
(1 
days 
before 
surgery)
Operati
on day 
 
Visiting V1 
 
 
Visiting v2 
至出院2 
1m 
2m 
3m 
4m 
6m 
12m 
Until the end 
of the study 
informed consent 
√ 
 
 
 
 
 
 
 
 
 
Inclusion / exclusion 
criteria 
√ 
 
 
 
 
 
 
 
 
 
Vital signs 
√ 
√ 
√ 
 
 
 
 
 
 
 
physical examination 
√ 
√ 
 
 
 
 
 
 
 
 
Fracture classification  
√ 
 
 
 
 
 
 
 
 
 
random 
√ 
 
 
 
 
 
 
 
 
 
Combined treatment and 
diseases 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
Routine blood test 
√ 
 
√ 
 
 
 
 
 
 
 
Urine routine 
√ 
 
 
 
 
 
 
 
 
 
Blood biochemistry 
√ 
 
√ 
 
 
 
 
 
 
 
Coagulation function 
√ 
 
 
 
 
 
 
 
 
 
Routine electrocardiogram 
√ 
 
 
 
 
 
 
 
 
 
pulmonary function 
√ 
 
 
 
 
 
 
 
 
 
Operative time and 
intraoperative bleeding 
 
√ 
 
 
 
 
 
 
 
 
VAS score(rest, 
movement)3 
 
 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
X-ray 
and 
CT 
after 
operation 4 
 
 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
HSS scores 
 
 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
Adverse events monitoring 
and recording 
 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
√ 

Project name:Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial Plateau Fractures 
                                                                              The Second Affiliated Hospital of Wenzhou Medical University 
14 
Version number: version 1.1 date: 2017-09-01 
 
Explain： 
1. Within 14 days before randomization, the same organization completed the test and inspection report of the same project, which can be used as the baseline result of 
screening period. 
2.The daily morning measurement of vital signs after the operation until the leaving day, the first day of blood routine and biochemical routine after surgery and every 
three days thereafter retest, routine postoperative analgesia for 3 days, as the subjects of analgesic requirements, the method of analgesia, determined by the doctor in 
charge, and do the record. 
3.VAS were assessed on the first postoperative days to discharge day before the daily infusion. 
4. Routine X-ray and CT examination were performed second days after operation, and were followed up regularly in 1, 2, 3, 4, 6 and 12mouths after operation. 
5. Routine blood test: red blood cell (RBC), white blood cell (WBC), neutrophil (NEUT), hemoglobin (Hb), platelet (PLT), hematocrit (HCT), C reactive protein (CRP), 
erythrocyte sedimentation rate (ESR). 
6.Routine urine test with urine (U-GLU), urine protein (PRO), urine red blood cell (BLD), white blood cell (LEU). 
7.Blood biochemical detection: containing aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin (TBIL), urea 
nitrogen or urea (BUN or Urea), creatinine (sCr or Cr), uric acid (UA), fasting blood glucose (FBG). 
8.Coagulation function: including prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR), thrombin time (TT), 
fibrinogen (FIB).