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Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty

Primary Purpose

Osteoarthritis, Patient-specific Instruments

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
patient-specific instruments
The Signature™ Vanguard
conventional instruments
Vanguard PS(posterior stabilized)
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Patient-specific Instruments

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • over 19 year old
  • Patients for total knee arthroplasty of both knee
  • over 5 degree in lateral bowing of femur
  • having medicare insurance

Exclusion Criteria:

  • Rheumatoid arthritis
  • Other inflammatory arthritis
  • Neuropsychiatric patients
  • Hepatic insufficiency
  • Renal insufficiency
  • over 40 of body mass index
  • Chronic opioid use (taking opioids for longer than 3 months)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    patient-specific instruments group

    conventional instruments group

    Arm Description

    procedure: PSI (patient-specific instruments) will be used as the cutting guide in total knee arthroplasty.

    procedure: Conventional instruments will be used as the cutting guide in total knee arthroplasty.

    Outcomes

    Primary Outcome Measures

    Changes in Range of Motion (ROM)

    Secondary Outcome Measures

    Changes in WOMAC (Western Ontario and McMaster University Arthritis Index)
    Changes in Knee Society Score
    Changes in Anterior and posterior stress view on X-ray

    Full Information

    First Posted
    December 8, 2016
    Last Updated
    December 13, 2016
    Sponsor
    The Catholic University of Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02993016
    Brief Title
    Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty
    Official Title
    Comparison of Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Catholic University of Korea

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Total knee arthroplasty (TKA) has a high success rate for addressing pain and improving function. However, in instances where incorrect positioning and malignment of the TKA components are observed, patients can experience a range of negative postoperative outcomes such as loss of thickness of polyethylene tibial bearings, eccentric loading, implant loosening, and eventual early revision. To avoid these complications, achieving a postoperative alignment within the range of 0°±3° of the mechanical axis is recommended. Manual intramedullary/extramedullary guides are not thought to be capable of consistently achieving axes in this range, and though computer-assisted navigation has shown superior results in comparison with conventional instrumentation, it is also limited by increased surgical times and no clear superiority in improving short-term clinical outcomes. Thus, there has been in a push in the orthopaedic community to create more precise technologies to aid in the reconstruction of the knee's mechanical axis. Patient-specific instrumentation (PSI), which uses anatomical data obtained primarily from pre-operative axial computed tomography (CT) or magnetic resonance imaging (MRI) to create disposable cutting jigs individualized to the patient's unique anatomy, was created with this goal. This study aims to compare the clinical results of conventional and patient-specific instruments in total knee arthroplasty.
    Detailed Description
    The objective of this work was to compare pain, stiffness, function and accuracy between groups at minimum 2 year postoperatively. The investigators hypothesized that PSI would lead to a neutral mechanical axis on average more frequently than conventional instrumentation. The study design is a double-blind randomized controlled trial. Randomly, fifty patients planed to undergo total knee arthroplasty using conventional instruments and other fifty patients undergo total knee arthroplasty using patient-specific instruments. The clinical outcome is comparative preoperative, postoperative 6weeks, 3months, 6months and 1years. And clinical score consists of Range of Motion (ROM), WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale (preoperative and postoperative 6, 12, 24 months), Knee Society Score (preoperative and postoperative 6, 12, 24 months), Anterior and posterior stress view on X-ray (preoperative and postoperative 6, 12, 24 months).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Patient-specific Instruments

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    patient-specific instruments group
    Arm Type
    Experimental
    Arm Description
    procedure: PSI (patient-specific instruments) will be used as the cutting guide in total knee arthroplasty.
    Arm Title
    conventional instruments group
    Arm Type
    Active Comparator
    Arm Description
    procedure: Conventional instruments will be used as the cutting guide in total knee arthroplasty.
    Intervention Type
    Procedure
    Intervention Name(s)
    patient-specific instruments
    Intervention Type
    Device
    Intervention Name(s)
    The Signature™ Vanguard
    Intervention Type
    Procedure
    Intervention Name(s)
    conventional instruments
    Intervention Type
    Device
    Intervention Name(s)
    Vanguard PS(posterior stabilized)
    Primary Outcome Measure Information:
    Title
    Changes in Range of Motion (ROM)
    Time Frame
    Changes from Baseline Range of Motion at postoperative 1 year
    Secondary Outcome Measure Information:
    Title
    Changes in WOMAC (Western Ontario and McMaster University Arthritis Index)
    Time Frame
    Changes from Baseline score to score of postoperative 1 year
    Title
    Changes in Knee Society Score
    Time Frame
    Changes from Baseline score to score of postoperative 1 year
    Title
    Changes in Anterior and posterior stress view on X-ray
    Time Frame
    Changes from Baseline Anterior and posterior stress view on X-ray at postoperative 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: over 19 year old Patients for total knee arthroplasty of both knee over 5 degree in lateral bowing of femur having medicare insurance Exclusion Criteria: Rheumatoid arthritis Other inflammatory arthritis Neuropsychiatric patients Hepatic insufficiency Renal insufficiency over 40 of body mass index Chronic opioid use (taking opioids for longer than 3 months)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yong In, MD, PhD
    Phone
    8290445228
    Email
    iy1000@catholic.ac.kr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Youngjun Choi, MD
    Phone
    8258985857
    Email
    wogur79@naver.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yong In, MD, PhD
    Organizational Affiliation
    the Catholic Univerisity of Korea Seoul St Mary's hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33794854
    Citation
    ALShammari SA, Choi KY, Koh IJ, Kim MS, In Y. Total knee arthroplasty in femoral bowing: does patient specific instrumentation have something to add? A randomized controlled trial. BMC Musculoskelet Disord. 2021 Apr 2;22(1):321. doi: 10.1186/s12891-021-04198-5.
    Results Reference
    derived

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    Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty

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