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

Not Applicable

• Conditions: Fracture Fixation; Orthopedic; Arthroscopy; Tibial Fractures
• Interventions: Procedure: Arthroscopic Assisted Balloon Tibioplasty

• Registration Number: NCT03327337
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-10-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-07
• Study Start: 2020-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Arthroscopic Assisted Balloon Tibioplasty	operate with open reduction and internal fixation on this group patients
experimental group	Arthroscopic Assisted Balloon Tibioplasty	operate with Arthroscopic Assisted Balloon Tibioplasty on this group patients

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Surgical duration	The day of the operation	Surgical duration
Intraoperative blood loss	Operation day	blood loss in surgery
VAS pain scores change after surgery	from the day of the operation to the day of discharge from hospital (up to 2 weeks).	The severity of lower limb pain after surgery
Hospitalization period after surgery	The day of the operation to the day of discharge	Hospitalization period after surgery
Complications	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.)	Complications including wound infection, reoperations, and posttraumatic arthritis (PTA) will be recorded.
the Short-Form Health Survey (SF-36) questionnaire	1, 3, 6, 12, and 24 months follow-up time	Health-related quality of life will be measured using the Short-Form Health Survey (SF-36) questionnaire during follow-up.