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

S

Second Affiliated Hospital of Wenzhou Medical University

Status

Unknown

Conditions

Orthopedic
Tibial Fractures
Arthroscopy
Fracture Fixation

Treatments

Procedure: Arthroscopic Assisted Balloon Tibioplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT03327337
SAHoWMU-CR2017-08-105

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups

experimental group
Experimental group
Description:
operate with Arthroscopic Assisted Balloon Tibioplasty on this group patients
Treatment:
Procedure: Arthroscopic Assisted Balloon Tibioplasty
control group
Other group
Description:
operate with open reduction and internal fixation on this group patients
Treatment:
Procedure: Arthroscopic Assisted Balloon Tibioplasty

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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