Using ROSA for Challenging The TKA Standard of Care
Recruiting · NCT06267482 · Interventional (participants receive a specific treatment) · Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
Where it is running
1 location listed.
- University Hospital - London, Ontario, Canada