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

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 Overview

• Status: Unknown
• Conditions: Tibial Fractures; Arthroscopy; Orthopedic; Fracture Fixation
• Intervention / Treatment: Procedure: Arthroscopic Assisted Balloon Tibioplasty

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: experimental group; operate with Arthroscopic Assisted Balloon Tibioplasty on this group patients	Procedure: Arthroscopic Assisted Balloon Tibioplasty; Under arthroscopy, the balloon supports the articular surface, with additional bone graft and necessary internal fixation
OTHER: control group; operate with open reduction and internal fixation on this group patients	Procedure: Arthroscopic Assisted Balloon Tibioplasty; Under arthroscopy, the balloon supports the articular surface, with additional bone graft and necessary internal fixation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (ACTUAL): October 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: SAHoWMU-CR2017-08-105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No