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Comparison of Highly Cross-Linked and Conventional Polyethylene in Total Knee Arthroplasty

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Total knee arthroplasty
Sponsored by
Ewha Womans University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

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

Inclusion Criteria:

  • osteoarthritis that was severe enough to warrant total knee arthroplasty after an adequate trial of nonoperative therapy, and the need for bilateral total knee arthroplasties

Exclusion Criteria:

  • inflammatory arthritis
  • osteoarthritis of the hip causing pain or restricted mobility
  • a foot or ankle disorder which limited walking
  • dementia or a neurological disorder including a past history of stroke which affected mobility

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Conventional

    Prolong

    Arm Description

    knee receiving Total knee arthroplasty with conventional polyethylene inserts

    knee receiving total knee arthroplasty with highly cross linked polyethylene insert

    Outcomes

    Primary Outcome Measures

    knee society knee score
    clinical evaluation of knee function by knee score. This knee score will be compared, between preoperative and the latest score, and between the latest scores of study and control group.

    Secondary Outcome Measures

    range of motion
    this value will be compared between preoperative and the latest value, and between the latest value of study and control groups

    Full Information

    First Posted
    December 13, 2013
    Last Updated
    December 18, 2013
    Sponsor
    Ewha Womans University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02020057
    Brief Title
    Comparison of Highly Cross-Linked and Conventional Polyethylene in Total Knee Arthroplasty
    Official Title
    Comparison of Highly Cross-Linked and Conventional Polyethylene in Posterior Cruciate-Substituting Total Knee Arthroplasty in the Same Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2006 (undefined)
    Primary Completion Date
    August 2010 (Actual)
    Study Completion Date
    September 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ewha Womans University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To our knowledge, there has been no information on in vivo clinical results of posterior cruciate-substituting arthroplasties using highly cross-linked polyethylene. We evaluated whether the clinical and radiographic results, incidence of post fracture of the tibial polyethylene insert, failure of the locking mechanism of the tibial polyethylene insert, and the incidence of osteolysis would be similar between posterior cruciate-substituting total knee prostheses using conventional and highly cross-linked polyethylene.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional
    Arm Type
    Active Comparator
    Arm Description
    knee receiving Total knee arthroplasty with conventional polyethylene inserts
    Arm Title
    Prolong
    Arm Type
    Experimental
    Arm Description
    knee receiving total knee arthroplasty with highly cross linked polyethylene insert
    Intervention Type
    Procedure
    Intervention Name(s)
    Total knee arthroplasty
    Intervention Description
    Total knee arthroplasty with standard incision and approach, and cement fixation. Zimmer Nexgen posterior stabilized total knee implants are used.
    Primary Outcome Measure Information:
    Title
    knee society knee score
    Description
    clinical evaluation of knee function by knee score. This knee score will be compared, between preoperative and the latest score, and between the latest scores of study and control group.
    Time Frame
    3 months, 1 year, and yearly thereafter the operation, until 15 years after the operation
    Secondary Outcome Measure Information:
    Title
    range of motion
    Description
    this value will be compared between preoperative and the latest value, and between the latest value of study and control groups
    Time Frame
    preoperative, 3 months, 1 year, and yearly thereafter the operation until 15 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: osteoarthritis that was severe enough to warrant total knee arthroplasty after an adequate trial of nonoperative therapy, and the need for bilateral total knee arthroplasties Exclusion Criteria: inflammatory arthritis osteoarthritis of the hip causing pain or restricted mobility a foot or ankle disorder which limited walking dementia or a neurological disorder including a past history of stroke which affected mobility
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Young-Hoo Kim, M.D.
    Organizational Affiliation
    Ewha Womans University Mokdong Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Highly Cross-Linked and Conventional Polyethylene in Total Knee Arthroplasty

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