Robot-Assisted Surgery for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new methods of robot-assisted surgery for individuals with knee osteoarthritis, a condition causing joint pain and stiffness. Researchers aim to determine if a robotic system, called ROSA (Robotic Surgical Assistant), improves outcomes compared to the usual surgical approach for knee replacements. Participants will be randomly assigned to one of three groups: the standard surgery group, a robot-assisted surgery group using a specific knee approach, or another robot-assisted group using a different approach. The trial will monitor recovery and results for one year after surgery, focusing on how the new methods affect healing, pain, and knee function. Individuals with knee osteoarthritis, who experience symptoms like pain and have a specific knee alignment, may be suitable for this study. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, helping researchers understand how it benefits more patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for these treatments?
Research has shown that the ROSA Knee System, used in both the ROSA PSA Parapatellar and Subvastus methods, is generally safe. Early studies suggest it enables precise surgery, with few patients needing follow-up surgeries soon after their initial treatment, indicating positive safety outcomes.
However, about 20% of patients report dissatisfaction after total knee replacement, according to some studies. While this doesn't directly relate to safety, it can affect patient satisfaction with the results. The ROSA system aims to improve surgical accuracy and reduce mistakes, thereby lowering the chance of complications.
Overall, while the ROSA system is new, initial safety data appear promising. As with any surgery, risks exist, and patients should discuss these with their healthcare provider.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about robot-assisted surgery for osteoarthritis because it promises greater precision and potentially quicker recovery times compared to traditional surgical methods. Traditional options often rely on manual techniques, which can vary in accuracy depending on the surgeon's skill. The ROSA PSA Parapatellar and Subvastus Approaches use robotic assistance to enhance surgical precision, which could lead to better alignment of joint components and improved long-term outcomes. This advanced technology aims to minimize tissue damage and accelerate healing, making it a groundbreaking approach in osteoarthritis treatment.
What evidence suggests that this trial's treatments could be effective for osteoarthritis?
Research has shown that the ROSA Knee System, a tool for robotic-assisted knee surgery, enhances surgical precision and accuracy. This often results in better knee function and outcomes for patients. In this trial, participants will join different treatment arms to assess the ROSA system's effectiveness. For those in the ROSA PSA Parapatellar Approach arm, the system aids in restoring crucial knee alignments, such as joint and kneecap height. Meanwhile, participants in the ROSA PSA Subvastus Approach arm demonstrated improved mobility and satisfaction after surgery. Overall, the ROSA Knee System shows promise in enhancing knee surgery results.12367
Who Is on the Research Team?
Brent Lanting, MD
Principal Investigator
London Health Sciences Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo total knee arthroplasty (TKA) using either the standard of care or ROSA-assisted approaches
Post-operative Monitoring
Participants are monitored for perioperative parameters, imaging, and patient-reported outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment, including functional outcomes and inflammatory response
What Are the Treatments Tested in This Trial?
Interventions
- ROSA PSA Parapatellar Approach
- ROSA PSA Subvastus Approach
ROSA PSA Parapatellar Approach is already approved in United States, European Union for the following indications:
- Total knee replacement for osteoarthritis
- Total knee replacement for osteoarthritis
Find a Clinic Near You
Who Is Running the Clinical Trial?
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Lead Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
London Health Sciences Centre OR Lawson Research Institute of St. Joseph's
Lead Sponsor
Lawson Health Research Institute
Lead Sponsor
Zimmer Biomet
Industry Sponsor
Dr. Nitin Goyal
Zimmer Biomet
Chief Medical Officer since 2021
MD from Harvard Medical School
Ivan Tornos
Zimmer Biomet
Chief Executive Officer since 2023
MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business