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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis, Knee, Arthropathy of Knee

Intervention / Treatment
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* Procedure: MAKO assisted unicondylar knee arthroplasty
* Procedure: NAVIO assisted unicondylar knee arthroplasty


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MAKO robotic assisted UKA<br>image base (MAKO) robotic assisted UKA | Procedure: MAKO assisted unicondylar knee arthroplasty<br>* MAKO assisted<br>|
| Active Comparator: NAVIO robotic assisted UKA<br>imageless (NAVIO) robotic assisted UKA | Procedure: NAVIO assisted unicondylar knee arthroplasty<br>* NAVIO assisted<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | operative time in minutes the higher value of blood loss is worse outcome | 1 day | 
| calculated total blood loss | 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 | post operative complications included infection, wound complication, stiffness and revision. the higher number of post operative outcome is the worse outcomes | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MAKO, NAVIO, robotic surgery, UKA, surgical time, KSS, KFS