RECRUITING Not applicable ClinicalTrials.gov

Using ROSA for Challenging The TKA Standard of Care

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's • ClinicalTrials.gov ID: NCT06267482

Registry updated: 2026-09-21

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Description

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.

Interventions

ROSA PSA Parapatellar Approach (Procedure)
This intervention will consist of using the ROSA alongside patient-specific alignment. The knee incision will be the same as the standard of care (medial parapatellar approach).
ROSA PSA Subvastus Approach (Procedure)
This intervention will consist of using the ROSA alongside patient-specific alignment. The knee incision will be an alternative, quad-sparing, subvastus approach.

Eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Active or prior infection * Medical condition precluding major surgery * Predominantly inflammatory arthropathy * Patellectomy * PCL deficiency * Major coronal plane deformity * Prior trauma to the tibia or femur resulting in malalignment, canal occlusion, or open reduction and internal fixation * Valgus alignment * Neurologic condition limiting mobility * Bone defects requiring augments, cones and/or stemmed implants * Intraoperative findings of insufficient contact between the implant and the bone surface * Body Mass Index of 40 or more

Conditions

Knee Osteoarthritis

Locations

University Hospital — London, Ontario, Canada

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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