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

Not Applicable

Completed

• Conditions: Arthropathy of Knee; Osteoarthritis, Knee
• Interventions: Procedure: MAKO assisted unicondylar knee arthroplasty; Procedure: NAVIO assisted unicondylar knee arthroplasty

• Registration Number: NCT03954912
• Lead Sponsor: 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

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 Timeline

• Study Start: 2015-06-01
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01
• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-17
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-18
• Last Update Posted: 2019-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MAKO robotic assisted UKA	MAKO assisted unicondylar knee arthroplasty	image base (MAKO) robotic assisted UKA
NAVIO robotic assisted UKA	NAVIO assisted unicondylar knee arthroplasty	imageless (NAVIO) robotic assisted UKA

Primary Outcome Measures

Name	Time	Method
operative time	1 day	operative time in minutes the higher value of blood loss is worse outcome
calculated total blood loss	1 day	total blood loss which was calculated using a formula based on patient blood volume and a decrease in hemoglobin

Secondary Outcome Measures

Name	Time	Method
post operative complications	12 months	post operative complications included infection, wound complication, stiffness and revision. the higher number of post operative outcome is the worse outcomes