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Anterior Knee Pain Between Unisex Knee Prosthesis VS Gender Specific Knee Prosthesis Following MIS TKA

Primary Purpose

Osteo Arthritis Knee, Knee Pain Chronic

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gender Solution®posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA and standard posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring anterior knee pain, gender knee prosthesis, patellar tracking, unisex knee prosthesis, total knee arthroplasty, patellar resurfacing

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Aymptomatic knee OA with

  • varus deformity < 30 degrees
  • range of motion > 90 degrees
  • flexion contracture < 20 degrees
  • recurvatum < 20 degrees

Exclusion Criteria:

  • gout
  • postraumatic arthritis
  • osteonecrosis of knee
  • inflammatory joint disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    patient specific knee prosthesis

    Unisex knee prosthesis

    Arm Description

    TKA with Gender Solution® posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA

    TKA with posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA

    Outcomes

    Primary Outcome Measures

    anterior knee pain
    Visual analog scale for pain ( 0= no pain to 10= maximum pain), incidence for anterior knee pain (percent)
    patellar tracking
    patellar tilt > 5 degrees and/or patellar shift> 5 mm= patellar maltracking

    Secondary Outcome Measures

    clinical outcome score
    knee society score (0-20= poor outcomes, 21-40=fair outcomes, 41-60= good outcomes, 61-80= very good outcomes, 81-100= excellent outcome)

    Full Information

    First Posted
    August 29, 2021
    Last Updated
    September 12, 2021
    Sponsor
    Thammasat University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05045651
    Brief Title
    Anterior Knee Pain Between Unisex Knee Prosthesis VS Gender Specific Knee Prosthesis Following MIS TKA
    Official Title
    The Incidence of Anterior Knee Pain Between Unisex Knee Prosthesis and Gender Specific Knee Prosthesis Following Minimally Invasive Surgery Total Knee Arthroplasty: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2014 (Actual)
    Primary Completion Date
    July 1, 2018 (Actual)
    Study Completion Date
    December 1, 2018 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Unisex knee prosthesis and patient specific knee prosthesis has the same anterior knee pain and patellar tracking
    Detailed Description
    Background:The anterior knee pain (AKP) is one of major problem of TKA. The incidence of anterior knee after TKA was 4% to 49%. The cause of AKP after TKA from surgical technique errors including joint line elevation, instability, malalignment of prosthesis, and maltracking of patella. However, AKP still has presented even high volume surgeon that prosthesis had good alignment and good stability, one of the risk factor is female. Due to female has higher Q-angle, greater anteroposterior (AP)/mediolateral(ML) ratio, smaller anterior condyle, and trochlea has higher degree of valgus angle than male. Therefore, female should has AKP even surgery with good surgical technique. The gender specific knee prosthesis was design for female to restore Q-angle, reduce anteroposterior (AP)/mediolateral(ML) ratio for reducing overhang of femoral component, increase valgus angle of trochlea groove, and reduce thickness of anterior part of prosthesis for prevention overstuff with patella. For these reasons, the gender specific knee prosthesis should reduce AKP and improve patellar tracking in female. And there is no study to compare AKP and patellar tracking between Unisex knee prosthesis and gender specific knee prosthesis following minimally invasive surgery (MIS) TKA. Investigators asked whether AKP and patellar tracking differ between unisex knee prosthesis and gender specific knee prosthesis following MIS TKA with patellar resurfacing. Methods:The participants were randomized into 2 groups (Gp) with computer program to make a list of random numbers of participant. Gp1 was gender specific knee prosthesis; consisted of 40 participants (40 knees) and Gp2 was unisex knee prosthesis; consisted of 40 participants (40 knees). The sample size was calculate base on anterior knee pain after TKA with a risk difference of 27% (3% versus 20%) (1,3). The 40 participants from each group would have 90% power at the 5% significant level. Patrticipants were follow up at 2 wks, 6 wks, 3 mo, 6mo, 1 year and 2 years. At each follow up, the % anterior knee pain, VAS for anterior knee pain were record. The knee society score also was recorded and compared between two group. All participants were operated with same surgeon and same instrumentation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteo Arthritis Knee, Knee Pain Chronic
    Keywords
    anterior knee pain, gender knee prosthesis, patellar tracking, unisex knee prosthesis, total knee arthroplasty, patellar resurfacing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    patient specific knee prosthesis
    Arm Type
    Experimental
    Arm Description
    TKA with Gender Solution® posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA
    Arm Title
    Unisex knee prosthesis
    Arm Type
    Experimental
    Arm Description
    TKA with posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA
    Intervention Type
    Procedure
    Intervention Name(s)
    Gender Solution®posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA and standard posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA
    Intervention Description
    gender specific knee prosthesis:design for female to restore Q-angle, reduce anteroposterior (AP)/mediolateral(ML) ratio for reducing overhang of femoral component, increase valgus angle of trochlea groove, and reduce thickness of anterior part of prosthesis for prevention overstuff with patella. The standard TKA or unisex knee prosthesis was design for female and male.
    Primary Outcome Measure Information:
    Title
    anterior knee pain
    Description
    Visual analog scale for pain ( 0= no pain to 10= maximum pain), incidence for anterior knee pain (percent)
    Time Frame
    4 years
    Title
    patellar tracking
    Description
    patellar tilt > 5 degrees and/or patellar shift> 5 mm= patellar maltracking
    Time Frame
    4 years
    Secondary Outcome Measure Information:
    Title
    clinical outcome score
    Description
    knee society score (0-20= poor outcomes, 21-40=fair outcomes, 41-60= good outcomes, 61-80= very good outcomes, 81-100= excellent outcome)
    Time Frame
    4 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aymptomatic knee OA with varus deformity < 30 degrees range of motion > 90 degrees flexion contracture < 20 degrees recurvatum < 20 degrees Exclusion Criteria: gout postraumatic arthritis osteonecrosis of knee inflammatory joint disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Boonchana Pongcharoen, MD
    Organizational Affiliation
    faculty of medicine, Thammasat university
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Anterior Knee Pain Between Unisex Knee Prosthesis VS Gender Specific Knee Prosthesis Following MIS TKA

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