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Patellar Resurfacing Under Subvastus Approach in Total Knee Arthroplasty

Primary Purpose

Osteoarthritis, Patella Resurfacing

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Patella resurfacing
Patella retention
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, Patella Resurfacing

Eligibility Criteria

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

Inclusion Criteria:

  • Patients for total knee arthroplasty
  • Having medicare insurance

Exclusion Criteria:

  • Patients who are not able to cooperate
  • Serious deformity (not suitable for a standard TKA prosthesis)
  • Patellar thickness less than 18 mm
  • Prior operation involving the extensor mechanism
  • Rheumatoid arthritis
  • Severe medical disability limiting the ability to walk
  • Revision surgery
  • Knees with predominantly patellofemoral arthrosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    patella resurfacing group

    patella retention

    Arm Description

    Procedure: Patellar component Resurfacing with onlay technique

    Procedure: patellar retention Trimming of osteophytes when appropriate

    Outcomes

    Primary Outcome Measures

    WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale
    Knee Society score

    Secondary Outcome Measures

    Feller's score
    Patients satisfaction using Visual Analog Score for pain

    Full Information

    First Posted
    February 4, 2016
    Last Updated
    February 16, 2016
    Sponsor
    The Catholic University of Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02683460
    Brief Title
    Patellar Resurfacing Under Subvastus Approach in Total Knee Arthroplasty
    Official Title
    Comparison of Clinical Results of Patella Resurfacing Versus Patellar Retention Under Subvastus Approach in Total Knee Arthroplasty: A Randomized, Controlled, Double-Blind Trial
    Study Type
    Interventional

    2. Study Status

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

    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
    This study aims to compare the clinical results of patella resurfacing or not under subvastus approach in total knee arthroplasty. Even though the excellent results of total knee arthroplasty(TKA), there is persistent controversy over whether or not to replace the patella. Anterior knee pain continued to be a unsolved problem of TKA patients. Some surgeons always performed patella resurfacing during total knee arthroplasty but the others didn't do that. It's up to surgeon's preference. There were several studies of patellar resurfacing or not in TKA. But previous studies almost have been done under other approach, not a subvastus approach. This study prospectively randomized patients receiving bilateral TKA with patellar resurfacing or not in each knee. Patients preference and clinical results was investigated in both knee of same patients who received patellar resurfacing or not during minimum 2 year follow up.
    Detailed Description
    The primary objective of this work was to compare pain, stiffness and function between groups at minimum 2 year postoperatively. Secondarily, we compared pain, patient preference at minimum 2 year postoperatively. The investigators hypothesized that there would be no difference between the two groups of subjects in the measured outcomes. Patients receiving TKA were prospectively enrolled before surgery and randomized intraoperatively to either receive patella replacement or not in both knee of same patients. Subjects were assessed pre-operatively and at 6 months, 1, 2 years postoperatively for pain, function, and stiffness using a disease-specific (Western Ontario and McMaster Osteoarthritis Index [WOMAC]) . Other measurements like Knee Society score, Feller's score, Patient satisfaction (VAS) also checked pre-operatively and at 6 months, 1, 2 years postoperatively.

    6. Conditions and Keywords

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

    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
    patella resurfacing group
    Arm Type
    Experimental
    Arm Description
    Procedure: Patellar component Resurfacing with onlay technique
    Arm Title
    patella retention
    Arm Type
    Active Comparator
    Arm Description
    Procedure: patellar retention Trimming of osteophytes when appropriate
    Intervention Type
    Procedure
    Intervention Name(s)
    Patella resurfacing
    Intervention Type
    Procedure
    Intervention Name(s)
    Patella retention
    Primary Outcome Measure Information:
    Title
    WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale
    Time Frame
    Change from preoperative score to postoperative 2 years
    Title
    Knee Society score
    Time Frame
    Change from preoperative score to postoperative 2 years
    Secondary Outcome Measure Information:
    Title
    Feller's score
    Time Frame
    Change from preoperative score to postoperative 2 years
    Title
    Patients satisfaction using Visual Analog Score for pain
    Time Frame
    Change from preoperative score to postoperative 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients for total knee arthroplasty Having medicare insurance Exclusion Criteria: Patients who are not able to cooperate Serious deformity (not suitable for a standard TKA prosthesis) Patellar thickness less than 18 mm Prior operation involving the extensor mechanism Rheumatoid arthritis Severe medical disability limiting the ability to walk Revision surgery Knees with predominantly patellofemoral arthrosis
    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
    Mansoo Kim, MD
    Phone
    8272333875
    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

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