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Is Second Knee at Risk During Simultaneous Bilateral Total Knee Arthroplasty.

Primary Purpose

Osteoarthritis, Knee, Infection, Periprosthetic Fracture Around Prosthetic Joint Implant

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
First Arthroplasty
Second Arthroplasty
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary bilateral knee osteoarthritis with refractory to conservative treatment
  • Patients who accept participation in the research and the randomization

Exclusion Criteria:

  • no history of malignancy
  • less than 75 years old
  • severe cardiac insufficiency and morbid obesity

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    First Knee

    Second Knee

    Arm Description

    The first knee is the knee where the surgery will begin to be applied.

    The second knee is the knee where the surgeon will apply secondly.

    Outcomes

    Primary Outcome Measures

    Local complications
    Local operation related complications rate

    Secondary Outcome Measures

    Full Information

    First Posted
    April 25, 2020
    Last Updated
    April 29, 2020
    Sponsor
    Bezmialem Vakif University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04367272
    Brief Title
    Is Second Knee at Risk During Simultaneous Bilateral Total Knee Arthroplasty.
    Official Title
    Is Second Knee at Risk During Simultaneous Bilateral Total Knee Arthroplasty.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 15, 2020 (Anticipated)
    Primary Completion Date
    May 15, 2021 (Anticipated)
    Study Completion Date
    June 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    The effects of single-team simultaneous bilateral total knee arthroplasty on peri- and postoperative complications are clear. The investigators hypothesized that second knee at risk during single-team simultaneous bilateral total knee arthroplasty and have more early postoperative complication rates than the first knee. Therefore, this prospective study compared minor and major local complications for 90 days postoperatively between the first and second during knee single-team simultaneous bilateral total knee arthroplasty.
    Detailed Description
    The investigators would like to compare operation related technical complications and periprosthetic joint infection rate between the first and second knee.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee, Infection, Periprosthetic Fracture Around Prosthetic Joint Implant

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    First Knee
    Arm Type
    Active Comparator
    Arm Description
    The first knee is the knee where the surgery will begin to be applied.
    Arm Title
    Second Knee
    Arm Type
    Experimental
    Arm Description
    The second knee is the knee where the surgeon will apply secondly.
    Intervention Type
    Procedure
    Intervention Name(s)
    First Arthroplasty
    Intervention Description
    First Knee
    Intervention Type
    Procedure
    Intervention Name(s)
    Second Arthroplasty
    Intervention Description
    Second Knee
    Primary Outcome Measure Information:
    Title
    Local complications
    Description
    Local operation related complications rate
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Primary bilateral knee osteoarthritis with refractory to conservative treatment Patients who accept participation in the research and the randomization Exclusion Criteria: no history of malignancy less than 75 years old severe cardiac insufficiency and morbid obesity
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Orkhan Aliyev, MD
    Phone
    +905059917419
    Email
    orkhanaliyev@outlook.com.tr

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

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