Robot Assisted Total Hip Arthroplasties

Study Overview
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Brief Summary
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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.

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

Conditions
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Hip Arthropathy

Intervention / Treatment
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* Device: VTS surgical robotic system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: robotic<br> | Device: VTS surgical robotic system<br>* TheVTS 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.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acetabular location accuracy | Proportion of abduction angle and anteversion angle of acetabular cup in lewinnek safe area | Within 1 week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | Time from skin incision to wound closure | Immediately after surgery | 
| 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 | 
| 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 | 
| 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 | 
| dislocation rate of hip joint | the proportion of participants encountered with dislocation of hip joint after THA | 6 months after surgery | 
| adverse events or complications | the rate of adverse events or complications in all the participants | 6 months after surgery |