search
Back to results

Comparative Outcomes Between Image-based Versus Imageless Robot-assisted Unicondylar Knee Arthroplasty

Primary Purpose

Osteoarthritis, Knee, Arthropathy of Knee

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MAKO assisted unicondylar knee arthroplasty
NAVIO assisted unicondylar knee arthroplasty
Sponsored by
Ramathibodi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring MAKO, NAVIO, robotic surgery, UKA, surgical time, KSS, KFS

Eligibility Criteria

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

Inclusion Criteria:

  • patients were those deemed suitable for unicondylar knee arthroplasty surgery
  • patients who could give informed consent
  • patients who willing to attend the prescribed follow-up.

Exclusion Criteria:

  • Patients who have medial osteoarthritis knee with following condition:

    1. Ligament insufficiency (anterior cruciate ligament rupture, collateral ligament insufficiency).
    2. Inflammatory arthritis
    3. A deformity requiring augmentation
    4. Neurological movement disorders
    5. pathology of the feet, ankles, hips, or opposite knee causing significant pain or gait alterations
  • Patients who ultimately required a total knee arthroplasty (valgus greater than 14 degree, multiple compartment osteoarthritis were contraindications to unicondylar knee arthroplasty.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    MAKO robotic assisted UKA

    NAVIO robotic assisted UKA

    Arm Description

    image base (MAKO) robotic assisted UKA

    imageless (NAVIO) robotic assisted UKA

    Outcomes

    Primary Outcome Measures

    operative time
    operative time in minutes the higher value of blood loss is worse outcome
    calculated total blood loss
    total blood loss which was calculated using a formula based on patient blood volume and a decrease in hemoglobin

    Secondary Outcome Measures

    post operative complications
    post operative complications included infection, wound complication, stiffness and revision. the higher number of post operative outcome is the worse outcomes

    Full Information

    First Posted
    May 13, 2019
    Last Updated
    June 18, 2019
    Sponsor
    Ramathibodi Hospital
    Collaborators
    Bhumibol Adulyadej Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03954912
    Brief Title
    Comparative Outcomes Between Image-based Versus Imageless Robot-assisted Unicondylar Knee Arthroplasty
    Official Title
    Comparative Outcomes Between Image-based (MAKO) Versus Imageless NAVIO Robot-assisted Unicondylar Knee Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2015 (Actual)
    Primary Completion Date
    January 1, 2018 (Actual)
    Study Completion Date
    January 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ramathibodi Hospital
    Collaborators
    Bhumibol Adulyadej Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This prospective cohort study was conducted with the aim of comparing relevant clinical outcomes which included intra (surgical time and blood loss), post-operative outcomes (range of motion, function, complications and revisions) and return to activity between imageless and image-based surgical system in medial unicondylar knee arthroplasty
    Detailed Description
    this prospective cohort study was conducted between 1st June 2015 and 1st July 2018 at Bhumibol Adulyadej Hospital, Bangkok, Thailand. A total of 33 medial compartment OA knee patients were randomly allocated to MAKO or NAVIO robotic assisted UKA. The outcomes assessed were intra-operative outcomes (operative time, blood loss) and postoperative outcomes (function, complications and revision) at 1 year after surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee, Arthropathy of Knee
    Keywords
    MAKO, NAVIO, robotic surgery, UKA, surgical time, KSS, KFS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    prospective cohort study
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MAKO robotic assisted UKA
    Arm Type
    Active Comparator
    Arm Description
    image base (MAKO) robotic assisted UKA
    Arm Title
    NAVIO robotic assisted UKA
    Arm Type
    Active Comparator
    Arm Description
    imageless (NAVIO) robotic assisted UKA
    Intervention Type
    Procedure
    Intervention Name(s)
    MAKO assisted unicondylar knee arthroplasty
    Intervention Description
    MAKO assisted
    Intervention Type
    Procedure
    Intervention Name(s)
    NAVIO assisted unicondylar knee arthroplasty
    Intervention Description
    NAVIO assisted
    Primary Outcome Measure Information:
    Title
    operative time
    Description
    operative time in minutes the higher value of blood loss is worse outcome
    Time Frame
    1 day
    Title
    calculated total blood loss
    Description
    total blood loss which was calculated using a formula based on patient blood volume and a decrease in hemoglobin
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    post operative complications
    Description
    post operative complications included infection, wound complication, stiffness and revision. the higher number of post operative outcome is the worse outcomes
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients were those deemed suitable for unicondylar knee arthroplasty surgery patients who could give informed consent patients who willing to attend the prescribed follow-up. Exclusion Criteria: Patients who have medial osteoarthritis knee with following condition: Ligament insufficiency (anterior cruciate ligament rupture, collateral ligament insufficiency). Inflammatory arthritis A deformity requiring augmentation Neurological movement disorders pathology of the feet, ankles, hips, or opposite knee causing significant pain or gait alterations Patients who ultimately required a total knee arthroplasty (valgus greater than 14 degree, multiple compartment osteoarthritis were contraindications to unicondylar knee arthroplasty.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    32660619
    Citation
    Leelasestaporn C, Tarnpichprasert T, Arirachakaran A, Kongtharvonskul J. Comparison of 1-year outcomes between MAKO versus NAVIO robot-assisted medial UKA: nonrandomized, prospective, comparative study. Knee Surg Relat Res. 2020 Mar 12;32(1):13. doi: 10.1186/s43019-020-00030-x.
    Results Reference
    derived

    Learn more about this trial

    Comparative Outcomes Between Image-based Versus Imageless Robot-assisted Unicondylar Knee Arthroplasty

    We'll reach out to this number within 24 hrs