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

NCT ID: NCT03327337

Last Updated: 2019-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-12-31

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.

Conditions

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Arthroscopy Tibial Fractures Orthopedic Fracture Fixation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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experimental group

operate with Arthroscopic Assisted Balloon Tibioplasty on this group patients

Group Type EXPERIMENTAL

Arthroscopic Assisted Balloon Tibioplasty

Intervention Type PROCEDURE

Under arthroscopy, the balloon supports the articular surface, with additional bone graft and necessary internal fixation

control group

operate with open reduction and internal fixation on this group patients

Group Type OTHER

Arthroscopic Assisted Balloon Tibioplasty

Intervention Type PROCEDURE

Under arthroscopy, the balloon supports the articular surface, with additional bone graft and necessary internal fixation

Interventions

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Arthroscopic Assisted Balloon Tibioplasty

Under arthroscopy, the balloon supports the articular surface, with additional bone graft and necessary internal fixation

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Wang JQ, Jiang BJ, Guo WJ, Zhang WJ, Li AB, Zhao YM. Arthroscopic-assisted balloon tibioplasty versus open reduction internal fixation (ORIF) for treatment of Schatzker II-IV tibial plateau fractures: study protocol of a randomised controlled trial. BMJ Open. 2018 Aug 8;8(8):e021667. doi: 10.1136/bmjopen-2018-021667.

Reference Type DERIVED
PMID: 30093519 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SAHoWMU-CR2017-08-105

Identifier Type: -

Identifier Source: org_study_id

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