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ROSA PSA Parapatellar Approach for Osteoarthritis
Phase 4
Recruiting
Led By Brent Lanting, PhD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between the ages of 21 and 80 inclusive
Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
Awards & highlights
Study Summary
This trial will compare two different knee replacement surgery techniques using a robot-assisted approach and a conventional approach. Patients will be randomly assigned to one of three groups and followed for a year after surgery to assess
Who is the study for?
This trial is for adults aged 21-80 with knee osteoarthritis needing a total knee replacement, who have a specific type of knee alignment (varus deformity) between 0 to 10 degrees and healthy ligaments. Participants must be able to follow the study's procedures and provide consent.Check my eligibility
What is being tested?
The study compares traditional total knee arthroplasty (TKA) using the medial parapatellar approach with two ROSA robotic-assisted TKA approaches: one also using the medial parapatellar method, and another using the subvastus method. Patients are observed for one year post-surgery.See study design
What are the potential side effects?
While not explicitly listed, typical side effects from TKA may include pain at surgery site, swelling, blood clots, infection risk or issues related to anesthesia. Robotic assistance aims to minimize these but introduces risks associated with new technology.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 80 years old.
Select...
My knee's ligaments are strong enough to keep the back one.
Select...
I have severe knee pain from arthritis needing a knee replacement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Functional Outcome - 3D Ultrasound
Functional Outcome - Timed Up and Go test
Functional Outcome - Weight-bearing CT scan
+5 moreSecondary outcome measures
Health Ecominics
Trial Design
3Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Standard of care medial parapetallar approach
Group II: ROSA PSA Parapatellar ApproachActive Control1 Intervention
Arm using the ROSA with PSA and medial parapetallar approach
Group III: ROSA PSA Subvastus ApproachActive Control1 Intervention
Arm using the ROSA with PSA and medial subvastus approach
Find a Location
Who is running the clinical trial?
Zimmer BiometIndustry Sponsor
373 Previous Clinical Trials
67,157 Total Patients Enrolled
129 Trials studying Osteoarthritis
33,034 Patients Enrolled for Osteoarthritis
Lawson Health Research InstituteLead Sponsor
664 Previous Clinical Trials
413,990 Total Patients Enrolled
21 Trials studying Osteoarthritis
5,477 Patients Enrolled for Osteoarthritis
Brent Lanting, PhDPrincipal InvestigatorLondon Health Sciences Center
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