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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03954912
Recruitment Status : Completed
First Posted : May 17, 2019
Last Update Posted : June 20, 2019
Bhumibol Adulyadej Hospital
Information provided by (Responsible Party):
Jatupon Kongtharvonskul, Ramathibodi Hospital

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

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Arthropathy of Knee Procedure: MAKO assisted unicondylar knee arthroplasty Procedure: NAVIO assisted unicondylar knee arthroplasty Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Outcomes Between Image-based (MAKO) Versus Imageless NAVIO Robot-assisted Unicondylar Knee Arthroplasty
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: MAKO robotic assisted UKA
image base (MAKO) robotic assisted UKA
Procedure: MAKO assisted unicondylar knee arthroplasty
MAKO assisted

Active Comparator: NAVIO robotic assisted UKA
imageless (NAVIO) robotic assisted UKA
Procedure: NAVIO assisted unicondylar knee arthroplasty
NAVIO assisted

Primary Outcome Measures :
  1. operative time [ Time Frame: 1 day ]
    operative time in minutes the higher value of blood loss is worse outcome

  2. calculated total blood loss [ Time Frame: 1 day ]
    total blood loss which was calculated using a formula based on patient blood volume and a decrease in hemoglobin

Secondary Outcome Measures :
  1. post operative complications [ Time Frame: 12 months ]
    post operative complications included infection, wound complication, stiffness and revision. the higher number of post operative outcome is the worse outcomes

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jatupon Kongtharvonskul, principle investigator, Ramathibodi Hospital Identifier: NCT03954912    
Other Study ID Numbers: 2/62
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Jatupon Kongtharvonskul, Ramathibodi Hospital:
robotic surgery
surgical time
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases