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Clinical Trials/NCT04307251
NCT04307251
Completed
Not Applicable

Comparative Outcomes Between Imageless Robotic-assisted and Conventional Total Knee Arthroplasty : A Prospective, Randomized Controlled Trial

Navamindradhiraj University1 site in 1 country168 target enrollmentMarch 23, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Navamindradhiraj University
Enrollment
168
Locations
1
Primary Endpoint
Mechanical axis
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this study is to compare post-operative mechanical alignment (Hip-Knee-Ankle angle; HKA) between imageless robotic-assisted (Navio™ Robotics-assisted Surgical System) and Conventional Total Knee Arthroplasty

Registry
clinicaltrials.gov
Start Date
March 23, 2020
End Date
February 25, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Satit Thiengwittayaporn

Associate Professor

Navamindradhiraj University

Eligibility Criteria

Inclusion Criteria

  • Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty
  • Age 50-80 year
  • Patients with osteoarthritis who voluntarily participated in the project

Exclusion Criteria

  • Patients with osteoporosis
  • History of inflammatory arthroplathy
  • Previous fracture or open surgery on the same knee
  • Patients with bilateral total knee arthroplasty
  • Patients osteoarthritis with revision surgery

Outcomes

Primary Outcomes

Mechanical axis

Time Frame: Change from baseline mechanical axis at 6 weeks after surgery

Post-operative Mechanical Alignment; Hip-Knee-Ankle angle; If you divide the knee into quadrants, the ideal mechanical axis would bisect the knee (0), with medial zone (-1) or lateral zone (-1) being within physiologic range. With the notable exception of physiologic varus \<age 2 and physiologic valgus \<age 6, medial or lateral zones 2 or 3 would likely manifest symptoms and gait disturbance and thereby warrant surgical intervention

Secondary Outcomes

  • Knee Society and Knee Society function score(Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery)
  • Range of motion of knee(Change from baseline Range of motion of knee at 3 months, 6 months, and 12 months after surgery)
  • Oxford knee score(Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery)

Study Sites (1)

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