NCT04711720

A Randomized Controlled Trial for Patients Underwent Total Hip Arthroplasties Assisted by Surgical Navigation System

A Randomized Controlled, Multicenter Study for Patients Underwent Total Hip Arthroplasties Assisted by "VTS"Surgical Navigation System

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled, multicenter study. According to the inclusion criteria, volunteers were recruited from patients undergoing total hip arthroplasty. After signing the informed consent, the subjects were assigned to the experimental group and the control group through the central randomization system. The researchers will complete the total hip arthroplasty for patients in the experimental group with the assistance of surgical navigation system. The patients in the control group do not use the surgical navigation system. The proportion of acetabular abduction angle and anteversion angle in the lewinnek safe area is the primary outcome measurement. The operation time, WOMAC score, Harris score, range of motion and dislocation rate are the secondaryoutcome measurements. The incidence of complications, devices and other adverse events were recorded.

Conditions

• Hip Arthropathy

Interventions

Type	Name	Description
DEVICE	"VTS" surgical navigation system	The"VTS" surgical navigation system can accurately match the preoperative and intraoperative image data with the patient's anatomical structure on the operating table, track the surgical instruments during the operation, and update the position of the surgical instruments on the patient's image in real time, so that the doctor can clearly understand the position of the surgical instruments relative to the patient's anatomical structure, and make the operation procedure more accurate and safer.

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-02-01
• Completion: 2022-12-01
• First posted: 2021-01-15
• Last updated: 2021-01-29