Actively Recruiting

Phase 4
Age: 21Years - 80Years
All Genders
NCT06267482

Using ROSA for Challenging The TKA Standard of Care

Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2025-05-14

90

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

Sponsors

L

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Z

Zimmer Biomet

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a prospective, randomized controlled trial using the cruciate retaining, MC Persona to comparing the conventional TKA to ROSA assisted TKA. Patients will be randomized to one of three study trial arms. 1. Standard of care medial parapetallar approach (Control) 2. ROSA PSA medial parapetallar approach 3. ROSA PSA medial subvastus approach Participants will be followed for 1 year post surgery with a combination of perioperative parameters, imaging, patient reported outcomes, functional outcomes, blood and tissue sampling for inflammatory information and activity levels.

CONDITIONS

Official Title

Using ROSA for Challenging The TKA Standard of Care

Who Can Participate

Age: 21Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
  • Varus knee deformity of 0 to 10 degrees
  • Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
  • Between the ages of 21 and 80 inclusive
  • Patients willing and able to comply with follow-up requirements and self-evaluations
  • Ability to give informed consent
Not Eligible

You will not qualify if you...

  • Active or prior infection
  • Medical condition precluding major surgery
  • Predominantly inflammatory arthropathy
  • Patellectomy
  • Posterior cruciate ligament deficiency
  • Major coronal plane deformity
  • Prior trauma to the tibia or femur causing malalignment, canal occlusion, or requiring open reduction and internal fixation
  • Valgus alignment
  • Neurologic condition limiting mobility
  • Bone defects needing augments, cones, or stemmed implants

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital

London, Ontario, Canada

Actively Recruiting

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Research Team

L

Lyndsay Somerville, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

3

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Using ROSA for Challenging The TKA Standard of Care | DecenTrialz