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Comparison Between Robotic-arm Assisted Total Knee Replacement and Traditional Total Knee Replacement

Primary Purpose

Osteoarthritis, Knee

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
robotic assisted total knee replacement
traditional total knee replacement
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring robotic-arm assisted, total knee replacement, kinematic alignment

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age between 18 years and 85 years
  • primary total knee replacement

Exclusion Criteria:

  • obvious bone defect
  • infection
  • BMI>>35kg/m2
  • severe osteoporosis
  • mental disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    robotic-arm assisted modified kinematic alignment total knee replacement

    traditional manual total knee replacement

    Arm Description

    The patients in this group receive robotic-arm assisted total knee replacement. And these patients achieve modified kinematic alignment.

    The patients in this group receive traditional manual total knee replacement. And these patients achieve traditional alignment.

    Outcomes

    Primary Outcome Measures

    KSS score
    Keen Society Score

    Secondary Outcome Measures

    HKA angle
    hip-knee-ankle angle
    mLDFA
    mechanical lateral distal femoral angle
    mMPTA
    mechanical medial proximal tibial angle
    SFCA
    sagittal femoral component angle
    knee ROM
    knee range of motion
    blood loss
    the intraoperative blood loss
    surgical duration
    the duration of the operation
    complication
    complications after the surgery

    Full Information

    First Posted
    May 22, 2022
    Last Updated
    May 24, 2022
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05391152
    Brief Title
    Comparison Between Robotic-arm Assisted Total Knee Replacement and Traditional Total Knee Replacement
    Official Title
    Comparison Between Robotic-Arm Assisted Modified Kinematic Alignment Total Knee Replacement And Traditional Manual Alignment Total Knee Replacement：A Prospective Multicenter, Double-Blind Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    May 1, 2025 (Anticipated)
    Study Completion Date
    October 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a multicenter, prospective, and case-control study. Five joint centers and 100 participants will be included. The study group used robotic-assisted modified kinematic alignment total knee replacement, and the control study used traditional alignment manual total knee replacement. The knee society score (KSS), Hip-knee-ankle(HKA) angle, mechanical lateral distal femoral angle(mLDFA), mechanical medial proximal tibial angle(mMPTA), sagittal femoral component angle(SFCA), range of motion(ROM), WOMAC score, SF-36, Visual Analogue Scale(VAS score), surgical time, blood loss, and complications are evaluated and compared.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee
    Keywords
    robotic-arm assisted, total knee replacement, kinematic alignment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    robotic-arm assisted modified kinematic alignment total knee replacement
    Arm Type
    Experimental
    Arm Description
    The patients in this group receive robotic-arm assisted total knee replacement. And these patients achieve modified kinematic alignment.
    Arm Title
    traditional manual total knee replacement
    Arm Type
    Active Comparator
    Arm Description
    The patients in this group receive traditional manual total knee replacement. And these patients achieve traditional alignment.
    Intervention Type
    Device
    Intervention Name(s)
    robotic assisted total knee replacement
    Intervention Description
    the study group used robotic-arm assisted total knee replacement.
    Intervention Type
    Device
    Intervention Name(s)
    traditional total knee replacement
    Intervention Description
    the control group used traditional total knee replacement
    Primary Outcome Measure Information:
    Title
    KSS score
    Description
    Keen Society Score
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    HKA angle
    Description
    hip-knee-ankle angle
    Time Frame
    3 months
    Title
    mLDFA
    Description
    mechanical lateral distal femoral angle
    Time Frame
    3 months
    Title
    mMPTA
    Description
    mechanical medial proximal tibial angle
    Time Frame
    3 months
    Title
    SFCA
    Description
    sagittal femoral component angle
    Time Frame
    3 months
    Title
    knee ROM
    Description
    knee range of motion
    Time Frame
    3 months
    Title
    blood loss
    Description
    the intraoperative blood loss
    Time Frame
    intraoperative
    Title
    surgical duration
    Description
    the duration of the operation
    Time Frame
    intraoperative
    Title
    complication
    Description
    complications after the surgery
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age between 18 years and 85 years primary total knee replacement Exclusion Criteria: obvious bone defect infection BMI>>35kg/m2 severe osteoporosis mental disease

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison Between Robotic-arm Assisted Total Knee Replacement and Traditional Total Knee Replacement

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