Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-31 @ 11:01 PM
Study NCT ID:
NCT05947734
Status:
COMPLETED
Last Update Posted:
2023-07-18
First Post:
2023-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robot Assisted Total Hip Arthroplasties
Sponsor:
Peking University Third Hospital
Organization:
Study Overview
Official Title:
A Randomized Controlled, Multicenter Study for Patients Underwent Total Hip Arthroplasties Assisted by "VTS" Surgical Robotic System
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 robotic system. The patients in the control group do not use the surgical robotic 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, SF-36 and dislocation rate are the secondary outcome measurements. The incidence of complications, devices and other adverse events were recorded.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: