A Randomized Controlled Trial for Patients Underwent Total Hip Arthroplasties Assisted by Surgical Navigation System
Primary Purpose
Hip Arthropathy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
"VTS" surgical navigation 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Navigation
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
Full Information
NCT ID
NCT04711720
First Posted
January 13, 2021
Last Updated
January 27, 2021
Sponsor
Peking University Third Hospital
Collaborators
Qianfoshan Hospital, Chifeng Municipal Hospital, Jining Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04711720
Brief Title
A Randomized Controlled Trial for Patients Underwent Total Hip Arthroplasties Assisted by Surgical Navigation System
Official Title
A Randomized Controlled, Multicenter Study for Patients Underwent Total Hip Arthroplasties Assisted by "VTS"Surgical Navigation System
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
Collaborators
Qianfoshan Hospital, Chifeng Municipal Hospital, Jining Medical University
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 navigation system. The patients in the control group do not use the surgical navigation 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, range of motion and dislocation rate are the secondaryoutcome 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
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Navigation
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
"VTS" surgical navigation system
Intervention Description
The"VTS" surgical navigation system can accurately match the preoperative and intraoperative image data with the patient's anatomical structure on the operating table, track the surgical instruments during the operation, and update the position of the surgical instruments on the patient's image in real time, so that the doctor can clearly understand the position of the surgical instruments relative to the patient's anatomical structure, and 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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huan Tian, MD PhD
Phone
+8613511065187
Email
tianhua@bjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao Geng, MD
Phone
+8618811332096
Email
gengxiao@bjmu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Randomized Controlled Trial for Patients Underwent Total Hip Arthroplasties Assisted by Surgical Navigation System
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