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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

Tracking Information
First Submitted Date  ICMJE May 13, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date June 20, 2019
Actual Study Start Date  ICMJE June 1, 2015
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • operative time [ Time Frame: 1 day ]
    operative time in minutes the higher value of blood loss is worse outcome
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • intraoperative blood loss [ Time Frame: 1 day ]
    blood loss in milliliter the higher value of blood loss is worse outcome
  • operative time [ Time Frame: 1 day ]
    operative time in minutes the higher value of blood loss is worse outcome
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Outcomes Between Image-based Versus Imageless Robot-assisted Unicondylar Knee Arthroplasty
Official Title  ICMJE Comparative Outcomes Between Image-based (MAKO) Versus Imageless NAVIO Robot-assisted Unicondylar Knee Arthroplasty
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
prospective cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis, Knee
  • Arthropathy of Knee
Intervention  ICMJE
  • Procedure: MAKO assisted unicondylar knee arthroplasty
    MAKO assisted
  • Procedure: NAVIO assisted unicondylar knee arthroplasty
    NAVIO assisted
Study Arms  ICMJE
  • Active Comparator: MAKO robotic assisted UKA
    image base (MAKO) robotic assisted UKA
    Intervention: Procedure: MAKO assisted unicondylar knee arthroplasty
  • Active Comparator: NAVIO robotic assisted UKA
    imageless (NAVIO) robotic assisted UKA
    Intervention: Procedure: NAVIO assisted unicondylar knee arthroplasty
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2019)
33
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1, 2018
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03954912
Other Study ID Numbers  ICMJE 2/62
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jatupon Kongtharvonskul, Ramathibodi Hospital
Study Sponsor  ICMJE Ramathibodi Hospital
Collaborators  ICMJE Bhumibol Adulyadej Hospital
Investigators  ICMJE Not Provided
PRS Account Ramathibodi Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP