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Clinical Trials/NCT03327337
NCT03327337UnknownNot Applicable

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

Second Affiliated Hospital of Wenzhou Medical University0 sites40 target enrollmentStarted: January 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
40
Primary Endpoint
Rasmussen scores change after surgery

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

experimental group

Experimental

operate with Arthroscopic Assisted Balloon Tibioplasty on this group patients

Intervention: Arthroscopic Assisted Balloon Tibioplasty (Procedure)

control group

Other

operate with open reduction and internal fixation on this group patients

Intervention: Arthroscopic Assisted Balloon Tibioplasty (Procedure)

Outcomes

Primary Outcomes

Rasmussen scores change after surgery

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • 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)

Investigators

Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Sponsor Class
Other
Responsible Party
Sponsor

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