Robot Assisted Total Hip Arthroplasties

Not Applicable

Completed

• Conditions: Hip Arthropathy
• Interventions: Device: "VTS" surgical robotic system

• Registration Number: NCT05947734
• Lead Sponsor: Peking University Third Hospital

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

Not available

Study Timeline

• Study Start: 2021-04-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-12-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-09
• Study First Submitted QC: 2023-07-09
• Last Update Submitted: 2023-07-15
• Study First Posted: 2023-07-17
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
robotic	"VTS" surgical robotic system	-

Primary Outcome Measures

Name	Time	Method
Acetabular location accuracy	Within 1 week after surgery	Proportion of abduction angle and anteversion angle of acetabular cup in lewinnek safe area

Secondary Outcome Measures

Name	Time	Method
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	6 months after surgery	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
adverse events or complications	6 months after surgery	the rate of adverse events or complications in all the participants
36-Item Short Form Survey (SF-36）	6 months after surgery	The SF-36 is a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being.
dislocation rate of hip joint	6 months after surgery	the proportion of participants encountered with dislocation of hip joint after THA
Operation time	Immediately after surgery	Time from skin incision to wound closure
Harris Hip Score (HHS)	6 months after surgery	a rating scale with a maximum of 100 points, including the domains of pain, function, deformity, and motion

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China