A Randomized Controlled, Multicenter Study for Patients Underwent Total Hip Arthroplasties Assisted by "VTS" Surgical Robotic System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- Acetabular location accuracy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
robotic
Intervention: "VTS" surgical robotic system (Device)
Control
Outcomes
Primary Outcomes
Acetabular location accuracy
Time Frame: Within 1 week after surgery
Proportion of abduction angle and anteversion angle of acetabular cup in lewinnek safe area
Secondary Outcomes
- the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(6 months after surgery)
- adverse events or complications(6 months after surgery)
- 36-Item Short Form Survey (SF-36）(6 months after surgery)
- dislocation rate of hip joint(6 months after surgery)
- Operation time(Immediately after surgery)
- Harris Hip Score (HHS)(6 months after surgery)