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The Recovery Time of Quadriceps Strength After Total Knee Arthroplasty (TKA): The Effect of Quadriceps Incision Length

Primary Purpose

Osteoarthritis of Knee

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Quadriceps incision < 2 cm
Quadriceps incision 2-4 cm
Quadriceps incision > 4 cm
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of Knee

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patients who diagnosed primary osteoarthritis of knee with

    1. varus or valgus deformity < 20 degrees
    2. preoperative range of motion > 90 degrees
    3. extension lag < 10 degrees
    4. Flexion contracture < 30 degrees

Exclusion Criteria:

  • Bilateral simultaneous total knee arthroplasty
  • Previous knee surgery
  • Inadequate exposure during the surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Group A

    Group B

    Group C

    Arm Description

    The length of Quadriceps incision was less than 2 cm.

    The length of Quadriceps incision was 2 to 4 cm.

    The length of Quadriceps incision was more than 4 cm.

    Outcomes

    Primary Outcome Measures

    The recovery time of Quadriceps strength
    Quadriceps strength was tested every month postoperatively, Recovery time was the amount of months which the Quadriceps strength returned to preoperative level.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 6, 2011
    Last Updated
    October 10, 2011
    Sponsor
    Mahidol University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01450904
    Brief Title
    The Recovery Time of Quadriceps Strength After Total Knee Arthroplasty (TKA): The Effect of Quadriceps Incision Length
    Official Title
    The Recovery Time of Quadriceps Strength After Total Knee Arthroplasty: The Effect of Quadriceps Incision Length
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2011 (undefined)
    Primary Completion Date
    October 2011 (Actual)
    Study Completion Date
    October 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mahidol University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Minimally invasive total knee arthroplasty (MIS-TKA) became the popular technique. It had the less postoperative pain and shorter recovery time compared to the conventional technique. With using MIS technique, less cut of quadriceps tendon was the key. It related to keep more quadriceps strength and improve functional performance after TKA. However, there was no previous studies about the effect of quadriceps incision length in the recovery time of the quadriceps strength. The investigators hypothesized that longer quadriceps incision affected the longer recovery time of quadriceps strength in MIS-TKA.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    The length of Quadriceps incision was less than 2 cm.
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    The length of Quadriceps incision was 2 to 4 cm.
    Arm Title
    Group C
    Arm Type
    Experimental
    Arm Description
    The length of Quadriceps incision was more than 4 cm.
    Intervention Type
    Procedure
    Intervention Name(s)
    Quadriceps incision < 2 cm
    Intervention Description
    MIS-TKA was performed with less than 2 cm Quadriceps incision length
    Intervention Type
    Procedure
    Intervention Name(s)
    Quadriceps incision 2-4 cm
    Intervention Description
    MIS-TKA was performed with 2 to 4 cm Quadriceps incision length
    Intervention Type
    Procedure
    Intervention Name(s)
    Quadriceps incision > 4 cm
    Intervention Description
    MIS-TKA was performed with more than 4 cm Quadriceps incision length
    Primary Outcome Measure Information:
    Title
    The recovery time of Quadriceps strength
    Description
    Quadriceps strength was tested every month postoperatively, Recovery time was the amount of months which the Quadriceps strength returned to preoperative level.
    Time Frame
    Upto 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patients who diagnosed primary osteoarthritis of knee with varus or valgus deformity < 20 degrees preoperative range of motion > 90 degrees extension lag < 10 degrees Flexion contracture < 30 degrees Exclusion Criteria: Bilateral simultaneous total knee arthroplasty Previous knee surgery Inadequate exposure during the surgery
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Keerati Charoencholvanich, MD
    Organizational Affiliation
    Mahidol University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Recovery Time of Quadriceps Strength After Total Knee Arthroplasty (TKA): The Effect of Quadriceps Incision Length

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