About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Active or prior infection
Medical condition precluding major surgery
Predominantly inflammatory arthropathy
Patellectomy
Trial design
Parallel
Treatments tested in this trial
ROSA PSA Parapatellar Approach
Procedure/SurgeryThis 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/SurgeryThis intervention will consist of using the ROSA alongside patient-specific alignment. The knee incision will be an alternative, quad-sparing, subvastus approach.
Treatment groups
Trial outcomes
Primary outcomes
Functional Outcome - Weight-bearing CT scan
Patients will undergo a weight-bearing CT scan to examine implant migration and bone position in the knee.
Functional Outcome - 3D Ultrasound
Patients will undergo a 3D Ultrasound to measure the inflammatory characteristics including Synovial fluid and synovial thickness for fibrosis in the supra-patellar region of the knee
Functional Outcome - Timed Up and Go test
Patients will undergo a Timed Up and Go (TUG) test. Patients will have to get up from a seated position, walk 10 feet, turn around and walk another 10 feet. This test is used to examine the function of the lower extremities. A time improvement of 2.27 Seconds will be considered clinically meaningful
Patient health status - Knee Society Score
This will be done by comparing the Knee Society Score (KSS) Patient-reported outcome measurement questionnaire given to patients. The KSS questionnaire looks at several factors such as patient satisfaction (scale from 1-5, 5 being the best), Patient expectation (scale from 1-5, 5 being the best) and patient's pain during activities (scale from No pain to severe pain)
Secondary outcomes
Health Ecominics
Patients will be asked to fill out a cost-diary to determine if the new methods help reduce resource consumption
Sponsors and contacts
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