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

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ClinicalTrials.gov Identifier: NCT03954912
Recruitment Status : Completed
First Posted : May 17, 2019
Last Update Posted : June 20, 2019
Sponsor:
Collaborator:
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

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

    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 ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jatupon Kongtharvonskul, principle investigator, Ramathibodi Hospital
ClinicalTrials.gov 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:
MAKO
NAVIO
robotic surgery
UKA
surgical time
KSS
KFS
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Osteoarthritis
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases