Knee Osteoarthritis study: ROSA PSA Subvastus Approach
Official title Using ROSA for Challenging The TKA Standard of Care
ClinicalTrials.gov ID: NCT06267482
What this study is testing
- What it's testing
- The study compares outcomes of a robotic‑assisted knee replacement to conventional surgery, looking at recovery, pain, function, and inflammation over one year.
- Who it's for
- Adults with knee osteoarthritis who are scheduled for total knee replacement.
- What's involved
- Participants will have knee surgery using one of three methods: standard surgery, robotic surgery with a medial approach, or robotic surgery with a medial subvastus approach. After surgery, they will have follow‑up visits, imaging, blood and tissue tests, and questionnaires about pain and function.
- Time commitment
- The study lasts one year after surgery, with scheduled follow‑up visits and tests during that period.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 80
You may be able to join if
- 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
You likely can't join if
- Active or prior infection
- Medical condition precluding major surgery
- Predominantly inflammatory arthropathy
- Patellectomy
- PCL deficiency
- Major coronal plane deformity
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at London, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.