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A Comparison of Anatomically Aligned Versus Conventional in Unilateral Total Knee Arthroplasty

Primary Purpose

Knee Osteoarthritis, Anatomically Aligned Total Knee Arthroplasty

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Total knee arthroplasty implant
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

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

Inclusion Criteria:

  • Patients for bilateral total knee arthroplasty
  • having medicare insurance

Exclusion Criteria:

  • Rheumatoid arthritis
  • Other inflammatory arthritis
  • Crystal-induced arthritis
  • Septic arthritis
  • Neuropsychiatric patients
  • Previous knee operation history
  • Neuropsychiatric patients
  • Patients with preoperative severe limitation of motion (Flexion contracture ≥ 20, range of motion ≤ 90)
  • Patients with preoperative severe defomity of knee alignment (Varus or valgus angle ≥ 15)
  • Severe obese patients (BMI ≥ 40)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Anatomically aligned total knee arthroplasty

    Conventaional total knee arthroplasty

    Arm Description

    Use anatomically aligned TKA implant (Journey II Bi-cruciate substituting total knee system, JII-BCS, Smith & Nephew) in patients undergoing unilateral TKA

    Use conventional TKA implant (Legion total knee system, JII-BCS, Smith & Nephew) in patients undergoing unilateral TKA

    Outcomes

    Primary Outcome Measures

    Change in Western Ontario and McMaster Universities Index(WOMAC index)

    Secondary Outcome Measures

    Change in Knee Society Score
    Change in Range of Motion

    Full Information

    First Posted
    October 31, 2019
    Last Updated
    November 26, 2019
    Sponsor
    The Catholic University of Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04181528
    Brief Title
    A Comparison of Anatomically Aligned Versus Conventional in Unilateral Total Knee Arthroplasty
    Official Title
    A Comparison of Anatomically Aligned Versus Conventional in Unilateral Total Knee Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2019 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

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

    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
    Total knee arthroplasty(TKA) is a successful orthopedic surgery with excellent clinical outcome and survival. However, there are concerns about patient satisfaction in previous reports, and dissatisfaction rate of 15-30% is reported in clinical outcomes(PROMs) of some studies. Therefore, for improving the patient's outcome and satisfaction after total knee arthroplasty, it is necessary to change the design of the conventional total knee arthroplsaty implant. The knee is a joint structure with several dynamic functions, and not only the skeletal structure but also the soft tissue balance plays an important role in the function of the knee joint. New implants are being developed to overcome the limitations of conventional TKA implant, including the Journey II Bi-cruciate substituting total knee system (JII-BCS; Smith & Nephew). JII-BCS implant has normal articular geometry, more anatomical femoral shape, lateral tibial convex geometry, and asymmetrical tibial plateau, anterior and posterior cams, which has been shown in experimental studies to produce nearly normal knee movement by reproducing the actual normal anatomical alignment in vivo. The clinical results of the kinematic effects of this anatomcally aligned change are insufficient, and there is also a lack of comparative studies with conventional total knee arthroplasty implant. The purpose of this study is to compare outcomes between anatomically aligned TKA(JII-BCS) and conventional TKA(Legion total knee system, Smith & Nephew). This study is a randomized controlled study in patients undergoing unilateral total knee arthroplasty. A patient will undergo unilateral TKA with anatomically aligned or conventional TKA implant. The implant is determined using a random number table. Radiologic parameter, patients preference and clinical results was investigated in patients who received unilateral TKA during minimum 2 year follow up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis, Anatomically Aligned Total Knee Arthroplasty

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Anatomically aligned total knee arthroplasty
    Arm Type
    Experimental
    Arm Description
    Use anatomically aligned TKA implant (Journey II Bi-cruciate substituting total knee system, JII-BCS, Smith & Nephew) in patients undergoing unilateral TKA
    Arm Title
    Conventaional total knee arthroplasty
    Arm Type
    Active Comparator
    Arm Description
    Use conventional TKA implant (Legion total knee system, JII-BCS, Smith & Nephew) in patients undergoing unilateral TKA
    Intervention Type
    Device
    Intervention Name(s)
    Total knee arthroplasty implant
    Intervention Description
    In patients undergoing unilateral TKA, decide the implant of TKA (anatomically aligned or conventional TKA implant) will be decided using ramdon number table
    Primary Outcome Measure Information:
    Title
    Change in Western Ontario and McMaster Universities Index(WOMAC index)
    Time Frame
    hange from baseline score to score of postoperative1 year
    Secondary Outcome Measure Information:
    Title
    Change in Knee Society Score
    Time Frame
    Change from baseline score to score of postoperative1 year
    Title
    Change in Range of Motion
    Time Frame
    Change from baseline Range of Motion at postoperative1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients for bilateral total knee arthroplasty having medicare insurance Exclusion Criteria: Rheumatoid arthritis Other inflammatory arthritis Crystal-induced arthritis Septic arthritis Neuropsychiatric patients Previous knee operation history Neuropsychiatric patients Patients with preoperative severe limitation of motion (Flexion contracture ≥ 20, range of motion ≤ 90) Patients with preoperative severe defomity of knee alignment (Varus or valgus angle ≥ 15) Severe obese patients (BMI ≥ 40)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yong In, MD, PhD
    Phone
    821090445228
    Email
    iy1000@catholic.ac.kr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mansoo Mansoo, MD, PhD
    Phone
    821072333875
    Email
    kms3779@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

    Learn more about this trial

    A Comparison of Anatomically Aligned Versus Conventional in Unilateral Total Knee Arthroplasty

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