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临床试验/NCT03327337
NCT03327337Unknown不适用

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

Second Affiliated Hospital of Wenzhou Medical University0 个研究点目标入组 40 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
主要终点
Rasmussen scores change after surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • fresh closed fracture X-ray and CT examination confirmed Schatzker II-IV type tibial plateau fracture patients.
  • the patient signed the informed consent.

排除标准

  • Pathologic fractures, patients with neurologic disorders, and skeletally immature patients.

研究组 & 干预措施

experimental group

Experimental

operate with Arthroscopic Assisted Balloon Tibioplasty on this group patients

干预措施: Arthroscopic Assisted Balloon Tibioplasty (Procedure)

control group

Other

operate with open reduction and internal fixation on this group patients

干预措施: Arthroscopic Assisted Balloon Tibioplasty (Procedure)

结局指标

主要结局

Rasmussen scores change after surgery

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

  • Surgical duration(The day of the operation)
  • Intraoperative blood loss(Operation day)
  • VAS pain scores change after surgery(from the day of the operation to the day of discharge from hospital (up to 2 weeks).)
  • Hospitalization period after surgery(The day of the operation to the day of discharge)
  • 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.))
  • the Short-Form Health Survey (SF-36) questionnaire(1, 3, 6, 12, and 24 months follow-up time)

研究者

发起方
Second Affiliated Hospital of Wenzhou Medical University
申办方类型
Other
责任方
Sponsor

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