Robot Assisted Total Hip Arthroplasties
Primary Purpose
Hip Arthropathy
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
"VTS" surgical robotic system
Sponsored by

About this trial
This is an interventional treatment trial for Hip Arthropathy
Eligibility Criteria
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
Sites / Locations
- Peking University Third Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
robotic
Control
Arm Description
Outcomes
Primary Outcome Measures
Acetabular location accuracy
Proportion of abduction angle and anteversion angle of acetabular cup in lewinnek safe area
Secondary Outcome Measures
Operation time
Time from skin incision to wound closure
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
Harris Hip Score (HHS)
a rating scale with a maximum of 100 points, including the domains of pain, function, deformity, and motion
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.
dislocation rate of hip joint
the proportion of participants encountered with dislocation of hip joint after THA
adverse events or complications
the rate of adverse events or complications in all the participants
Full Information
NCT ID
NCT05947734
First Posted
July 9, 2023
Last Updated
July 15, 2023
Sponsor
Peking University Third Hospital
Collaborators
Qianfoshan Hospital, Chifeng Municipal Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05947734
Brief Title
Robot Assisted Total Hip Arthroplasties
Official Title
A Randomized Controlled, Multicenter Study for Patients Underwent Total Hip Arthroplasties Assisted by "VTS" Surgical Robotic System
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
Collaborators
Qianfoshan Hospital, Chifeng Municipal Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
robotic
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
"VTS" surgical robotic system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acetabular location accuracy
Description
Proportion of abduction angle and anteversion angle of acetabular cup in lewinnek safe area
Time Frame
Within 1 week after surgery
Secondary Outcome Measure Information:
Title
Operation time
Description
Time from skin incision to wound closure
Time Frame
Immediately after surgery
Title
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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
Time Frame
6 months after surgery
Title
Harris Hip Score (HHS)
Description
a rating scale with a maximum of 100 points, including the domains of pain, function, deformity, and motion
Time Frame
6 months after surgery
Title
36-Item Short Form Survey (SF-36)
Description
The SF-36 is a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being.
Time Frame
6 months after surgery
Title
dislocation rate of hip joint
Description
the proportion of participants encountered with dislocation of hip joint after THA
Time Frame
6 months after surgery
Title
adverse events or complications
Description
the rate of adverse events or complications in all the participants
Time Frame
6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100181
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Robot Assisted Total Hip Arthroplasties
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