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

Tibial Fractures Clinical Trial

— AABTFTPF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03327337
• Other study ID #: SAHoWMU-CR2017-08-105
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2019
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthroscopy
• Fracture Fixation
• Fractures, Bone
• Orthopedic
• Tibial Fractures

Intervention

Procedure:
• Arthroscopic Assisted Balloon Tibioplasty
Under arthroscopy, the balloon supports the articular surface, with additional bone graft and necessary internal fixation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rasmussen scores change after surgery	the knee joint Rasmussen scores change after surgery	3?6?12 and 24 mouth Rasmussen scores change after surgery
Primary	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
Primary	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	Intraoperative blood loss	blood loss in surgery	Operation day
Secondary	Surgical duration	Surgical duration	The day of the operation
Secondary	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).
Secondary	Hospitalization period after surgery	Hospitalization period after surgery	The day of the operation to the day of discharge
Secondary	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.)
Secondary	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