Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial Plateau Fractures

Study Overview
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Brief Summary
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The investigators use existing resources to carry out this new technology, in accord with the standard of the patients, were randomized to traditional fracture balloon tibia fixation or arthroscopic reduction under angioplasty, the original data and data acquisition in a certain period of time corresponding to the patient, through statistical and epidemiological analysis and comparison of the method of professional data analysis discussion and experience according to the analysis results, the balloon angioplasty tibial arthroscopy and traditional open reduction and internal fixation for the clinical differences between postoperative recovery of tibial plateau articular surface reduction and joint function, and feedback the results to guide the clinical diagnosis and treatment.

Detailed Description
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The Balloon Tibioplasty arthroscopic assisted forming technique based on the existing data, the subject of the design, 1. patients met the inclusion criteria, were randomized to traditional fracture tibial fixation or balloon assisted arthroscopic reduction under angioplasty, through follow-up, statistical evaluation after operation were compared between the two techniques for clinical curative effect the difference of tibial plateau articular surface reduction and recovery of joint function. 2., through the clinical practice, operation and experience summary, found that the new technology in the operation of the existing deficiencies, in order to improve the technology. 3 guide clinical diagnosis and treatment through results feedback and analysis.The investigators use existing resources to carry out this new technology, in accord with the standard of the patients, were randomized to traditional fracture balloon tibia fixation or arthroscopic reduction under angioplasty, the original data and data acquisition in a certain period of time corresponding to the patient, through statistical and epidemiological analysis and comparison of the method of professional data analysis discussion and experience according to the analysis results, the balloon angioplasty tibial arthroscopy and traditional open reduction and internal fixation for the clinical differences between postoperative recovery of tibial plateau articular surface reduction and joint function, and feedback the results to guide the clinical diagnosis and treatment.

Official Title
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Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial Plateau Fractures

Conditions
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Arthroscopy, Tibial Fractures, Orthopedic, Fracture Fixation

Intervention / Treatment
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* Procedure: Arthroscopic Assisted Balloon Tibioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: fresh closed fracture X-ray and CT examination confirmed Schatzker II-IV type tibial plateau fracture patients. the patient signed the informed consent. Exclusion Criteria: Pathologic fractures, patients with neurologic disorders, and skeletally immature patients.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>operate with Arthroscopic Assisted Balloon Tibioplasty on this group patients | Procedure: Arthroscopic Assisted Balloon Tibioplasty<br>* Under arthroscopy, the balloon supports the articular surface, with additional bone graft and necessary internal fixation<br>|
| Other: control group<br>operate with open reduction and internal fixation on this group patients | Procedure: Arthroscopic Assisted Balloon Tibioplasty<br>* Under arthroscopy, the balloon supports the articular surface, with additional bone graft and necessary internal fixation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rasmussen scores change after surgery | the knee joint Rasmussen scores change after surgery | 3、6、12 and 24 mouth Rasmussen scores change after surgery | 
| Rasmunssen radiological evaluation scores change after surgery | Rasmunssen radiological evaluation scores change after surgery | immediately, and at 2 weeks and 1, 3, 6, 12, and 24 months Rasmunssen radiological evaluation scores change after surgery | 
| The quality of reduction | The quality of reduction will be determined based on postoperative CT scans, which can directly measure the amount of residual depression | 2 weeks and 1, 3, 6, 12, and 24 months postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss | blood loss in surgery | Operation day | 
| Surgical duration | Surgical duration | The day of the operation | 
| VAS pain scores change after surgery | The severity of lower limb pain after surgery | from the day of the operation to the day of discharge from hospital (up to 2 weeks). | 
| Hospitalization period after surgery | Hospitalization period after surgery | The day of the operation to the day of discharge | 
| Complications | Complications including wound infection, reoperations, and posttraumatic arthritis (PTA) will be recorded. | 1, 3, 6, 12, and 24 months follow-up time. (PTA may not be seen in patients within the 24-month follow-up period, and we will perform follow-up for at least 10 years in all patients.) | 
| the Short-Form Health Survey (SF-36) questionnaire | Health-related quality of life will be measured using the Short-Form Health Survey (SF-36) questionnaire during follow-up. | 1, 3, 6, 12, and 24 months follow-up time |