Using ROSA for Challenging The TKA Standard of Care

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • ROSA PSA Parapatellar Approach

    Procedure/Surgery

    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/Surgery

    This intervention will consist of using the ROSA alongside patient-specific alignment. The knee incision will be an alternative, quad-sparing, subvastus approach.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: ROSA PSA Parapatellar ApproachActive comparator 1 intervention
Group C: ROSA PSA Subvastus ApproachActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Functional Outcome - Weight-bearing CT scan

Patients will undergo a weight-bearing CT scan to examine implant migration and bone position in the knee.

Time frame
Pre-operation, 1-3 days post-op, 6-weeks post-op, and 1-year post-op
2

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

Time frame
Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
3

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

Time frame
Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
4

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)

Time frame
Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op

Secondary outcomes

1

Health Ecominics

Patients will be asked to fill out a cost-diary to determine if the new methods help reduce resource consumption

Time frame
Pre-operation, 1-3 days post-op, 6-weeks post-op, 3-months post-op

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.