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Robotic-Assisted Versus Conventional Total Knee Arthroplasty(TKA)

Primary Purpose

Arthritis, Knee Arthropathy, Robotics

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Robotic-assisted TKA
Conventional TKA
Sponsored by
Ewha Womans University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • end stage knee arthritis

Exclusion Criteria:

  • mild knee deformity
  • inflammatory arthritis
  • foot and ankle disorder
  • dementia
  • hip disease
  • history of a stroke
  • older than 65 years of age

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Robot

    Conventional

    Arm Description

    TKA is done with robotic-assisted manner. Final implantation of implants is done by surgeons, same as the conventional way. Robotic-assisted TKA for this arm.

    TKA is done with conventional instruments. Conventional TKA for this arm.

    Outcomes

    Primary Outcome Measures

    Knee society Knee score
    a proven score for the measurement of knee function, the score ranges from 0 to 100, 100 being the best possible score, indicating normal knee function

    Secondary Outcome Measures

    WOMAC score
    A tool to evaluate patient function associated with knee. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). The total score is summed from individual sections, and 0 is the best possible score.

    Full Information

    First Posted
    August 19, 2018
    Last Updated
    July 21, 2019
    Sponsor
    Ewha Womans University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03659318
    Brief Title
    Robotic-Assisted Versus Conventional Total Knee Arthroplasty(TKA)
    Official Title
    Is Clinical Outcome of Robotic-Assisted TKA Better Than Conventional Manual TKA?Prospective, Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2002 (Actual)
    Primary Completion Date
    February 2008 (Actual)
    Study Completion Date
    July 2018 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    Robotic-assisted total knee arthroplasty (TKA) was introduced to attempt to enhance the precision of bone preparation, component alignment and ultimately improve clinical results and survivorship of TKA. Although several published data suggest that bone preparation, and knee component alignment were improved by using robotic assistance, there is no high-quality evidence from randomized trials at long-term of which investigators are aware evaluating whether the improved bone preparation and knee component alignment improved clinical function or longevity of the TKA.
    Detailed Description
    Robotic-assisted TKA was introduced in an attempt to enhance component alignment and to improve long-term clinical results and implant durability, particularly in younger patients. Several comparative studies of conventional and robotic-assisted TKAs demonstrated that improved alignment of the components was obtained after the robotic-assisted TKAs than conventional TKAs. To date, however, no comprehensive synthesis of long-term randomized data has been conducted specifically for robotic-assisted TKA, particularly in younger patients. It is crucial to determine whether improved alignment of the TKA components obtained by using robotic-assistance, would improve better long-term and functional results and survivorship of TKAs. The aims of the current study were to examine the two groups of patients after long-term follow-up to determine whether the clinical results, radiographic and CT scan results, and the survivorship of TKA would be better after robotic-assisted TKA than after conventional TKA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthritis, Knee Arthropathy, Robotics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    674 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Robot
    Arm Type
    Experimental
    Arm Description
    TKA is done with robotic-assisted manner. Final implantation of implants is done by surgeons, same as the conventional way. Robotic-assisted TKA for this arm.
    Arm Title
    Conventional
    Arm Type
    Active Comparator
    Arm Description
    TKA is done with conventional instruments. Conventional TKA for this arm.
    Intervention Type
    Procedure
    Intervention Name(s)
    Robotic-assisted TKA
    Intervention Description
    Total knee arthroplasty is carried out with help of robotic surgery system, using a Robodoc system. CT-based preoperative planning using ORTHODOC (Integrated Surgical Technology Corp) performed in the first step before the day of surgery, and the robotic-assisted surgery using the ROBODOC surgical assistance in the second step. The bone markers are registered to the computer, and the computer arm does all the cutting and preparation of bones. This is in contrast to conventional jigs and cutting blocks. Actual implantation of the implants is done by a surgeon. A Duracon posterior cruciate-substituting total knee prosthesis (Stryker Orthopedics, Mahawh, NJ, USA) are used in all knees.
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional TKA
    Intervention Description
    Total knee arthroplasty is carried out with classical, conventional, manual method. A surgeon measures the angle, length of the cuts with bone landmarks and specialized surgical instruments. After all the cuts actual implantation is done. A Duracon posterior cruciate-substituting total knee prosthesis (Stryker Orthopedics, Mahawh, NJ, USA) are used in all knees.
    Primary Outcome Measure Information:
    Title
    Knee society Knee score
    Description
    a proven score for the measurement of knee function, the score ranges from 0 to 100, 100 being the best possible score, indicating normal knee function
    Time Frame
    20 years after the surgery
    Secondary Outcome Measure Information:
    Title
    WOMAC score
    Description
    A tool to evaluate patient function associated with knee. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). The total score is summed from individual sections, and 0 is the best possible score.
    Time Frame
    20 years after the surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: end stage knee arthritis Exclusion Criteria: mild knee deformity inflammatory arthritis foot and ankle disorder dementia hip disease history of a stroke older than 65 years of age

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    7673281
    Citation
    Arima J, Whiteside LA, McCarthy DS, White SE. Femoral rotational alignment, based on the anteroposterior axis, in total knee arthroplasty in a valgus knee. A technical note. J Bone Joint Surg Am. 1995 Sep;77(9):1331-4. doi: 10.2106/00004623-199509000-00006.
    Results Reference
    background
    PubMed Identifier
    3068365
    Citation
    Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.
    Results Reference
    background
    PubMed Identifier
    17563698
    Citation
    Bellemans J, Vandenneucker H, Vanlauwe J. Robot-assisted total knee arthroplasty. Clin Orthop Relat Res. 2007 Nov;464:111-6. doi: 10.1097/BLO.0b013e318126c0c0.
    Results Reference
    background
    PubMed Identifier
    16213997
    Citation
    Crowder AR, Duffy GP, Trousdale RT. Long-term results of total knee arthroplasty in young patients with rheumatoid arthritis. J Arthroplasty. 2005 Oct;20(7 Suppl 3):12-6. doi: 10.1016/j.arth.2005.05.020.
    Results Reference
    background
    PubMed Identifier
    15513489
    Citation
    Decking J, Theis C, Achenbach T, Roth E, Nafe B, Eckardt A. Robotic total knee arthroplasty: the accuracy of CT-based component placement. Acta Orthop Scand. 2004 Oct;75(5):573-9. doi: 10.1080/00016470410001448.
    Results Reference
    background
    PubMed Identifier
    27325369
    Citation
    Jacofsky DJ, Allen M. Robotics in Arthroplasty: A Comprehensive Review. J Arthroplasty. 2016 Oct;31(10):2353-63. doi: 10.1016/j.arth.2016.05.026. Epub 2016 May 18.
    Results Reference
    background

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