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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
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Arthropathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 13, 2021
    Last Updated
    January 27, 2021
    Sponsor
    Peking University Third Hospital
    Collaborators
    Qianfoshan Hospital, Chifeng Municipal Hospital, Jining Medical University
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    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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