Robot Assisted Total Hip Arthroplasties

Hip Arthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05947734
• Other study ID #: VTSTHrobot
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2023
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: December 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of primary hip osteoarthritis(OA), fracture of femoral neck (FFN),or secondary hip osteoarthritis due to developmental dysplasia of the hip (DDH), hip avascular necrosis (AVN), rheumatoid arthritis (RA), ankylosing spondylitis (AS), and coxa plana

Exclusion Criteria:

• Severe vascular diseases of the lower extremity Neuromuscular diseases Infectious diseases Severe dysfunctions of major organs Severe neurosensory deficiencies caused by spinal diseases Unable to receive CT/MRI scans

Related Conditions & MeSH terms

• Hip Arthropathy
• Joint Diseases

Intervention

Device:
• "VTS" surgical robotic system
The"VTS" surgical robotic system can accurately match the preoperative and intraoperative image data with the patient's anatomical structure on the operating table, track and locate the surgical instruments during the operation. With the help of the robotic arm, the surgeon can make the operation procedure more accurate and safer.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University Third Hospital	Chifeng Municipal Hospital, Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acetabular location accuracy	Proportion of abduction angle and anteversion angle of acetabular cup in lewinnek safe area	Within 1 week after surgery
Secondary	Operation time	Time from skin incision to wound closure	Immediately after surgery
Secondary	the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	The WOMAC is a self administered questionnaire to assess joint function and quality of life for patients with osteoarthritis; it consists of 24 items: pain (5 items), stiffness (2 items), and physical function (17 items). The higher the total score, the worse the patient's pain, stiffness, and functional limitations. The WOMAC is validated for various languages, including Chinese	6 months after surgery
Secondary	Harris Hip Score (HHS)	a rating scale with a maximum of 100 points, including the domains of pain, function, deformity, and motion	6 months after surgery
Secondary	36-Item Short Form Survey (SF-36)	The SF-36 is a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being.	6 months after surgery
Secondary	dislocation rate of hip joint	the proportion of participants encountered with dislocation of hip joint after THA	6 months after surgery
Secondary	adverse events or complications	the rate of adverse events or complications in all the participants	6 months after surgery