search
Back to results

Ultra-Congruent(UC) Versus Posterior-stabilized(PS) Insert in Bilateral Total Knee Arthroplasty

Primary Purpose

Osteoarthritis, Ultra-Congruent(UC) Insert

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
total knee arthroplasty with ultra-congruent (UC) insert
total knee arthroplasty with posterior-stabilized (PS) insert
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, Ultra-Congruent(UC) Insert

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
  • 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

    Ultra-Congruent(UC) group

    posterior-stabilized(PS) group

    Arm Description

    Ultra-Congruent(UC) insert will be used in total knee arthroplasty.

    Posterior-stabilized(PS) insert will be used in total knee arthroplasty.

    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
    December 12, 2016
    Last Updated
    December 12, 2016
    Sponsor
    The Catholic University of Korea
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02992613
    Brief Title
    Ultra-Congruent(UC) Versus Posterior-stabilized(PS) Insert in Bilateral Total Knee Arthroplasty
    Official Title
    Comparison of Ultra-Congruent(UC) and Posterior-stabilized(PS) Insert in Bilateral Total Knee Arthroplasty
    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
    Numerous studies have echoed the superior clinical outcomes of posterior-stabilized (PS) total knee arthroplasty compared to posterior cruciate-retaining (CR) total knee arthroplasty. The post-cam mechanism of posterior-stabilized (PS) total knee arthroplasty has been postulated to provide reproducible femoral rollback and increased flexion. However, posterior-stabilized (PS) total knee arthroplasty systems are purportedly limited due to several post-cam related problems, including post-cam dislocation, wear and breakage of post, and patellar clunk syndrome. Moreover, the post-cam mechanism requires additional bone resection and poses a risk for intercondylar fracture of the distal femur during box preparation. To overcome these issues, a fixed-bearing highly conforming ultra-congruent (UC) total knee arthroplasty was introduced. This study aims to compare the clinical results of Ultra-Congruent(UC) and posterior-stabilized(PS) insert in bilateral 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 the Ultra-Congruent(UC) insert would provide similar functional outcomes without increasing the incidence of adverse events. The study design is a double-blind randomized controlled trial. Fifty patients planed to undergo simultaneously bilateral total knee arthroplasty are randomised to be used Ultra-Congruent(UC) insert on one leg and posterior-stabilized(PS) insert on the other. 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, Knee Society Score, Anterior and posterior stress view on X-ray.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Ultra-Congruent(UC) Insert

    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
    Ultra-Congruent(UC) group
    Arm Type
    Experimental
    Arm Description
    Ultra-Congruent(UC) insert will be used in total knee arthroplasty.
    Arm Title
    posterior-stabilized(PS) group
    Arm Type
    Active Comparator
    Arm Description
    Posterior-stabilized(PS) insert will be used in total knee arthroplasty.
    Intervention Type
    Procedure
    Intervention Name(s)
    total knee arthroplasty with ultra-congruent (UC) insert
    Intervention Type
    Procedure
    Intervention Name(s)
    total knee arthroplasty with posterior-stabilized (PS) insert
    Primary Outcome Measure Information:
    Title
    Change in Western Ontario and McMaster Universities Index(WOMAC index)
    Time Frame
    Change 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: over 19 year old Patients for total knee arthroplasty of both knee 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)

    12. IPD Sharing Statement

    Learn more about this trial

    Ultra-Congruent(UC) Versus Posterior-stabilized(PS) Insert in Bilateral Total Knee Arthroplasty

    We'll reach out to this number within 24 hrs