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

June 18, 2019 updated by: Jatupon Kongtharvonskul, Ramathibodi Hospital

Comparative Outcomes Between Image-based (MAKO) Versus Imageless NAVIO Robot-assisted Unicondylar Knee Arthroplasty

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: 1 day
operative time in minutes the higher value of blood loss is worse outcome
1 day
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramathibodi Hospital

Collaborators

Bhumibol Adulyadej Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

May 13, 2019

First Submitted That Met QC Criteria

May 16, 2019

First Posted (Actual)

May 17, 2019

Study Record Updates

Last Update Posted (Actual)

June 20, 2019

Last Update Submitted That Met QC Criteria

June 18, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2/62

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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