Robot-Assisted Surgery for Osteoarthritis

Overseen By Lyndsay Somerville, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Disqualifiers: Infection, Inflammatory arthropathy, Neurologic condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1-3 days

90 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 6 7}

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

I am between 21 and 80 years old.

My knee bends slightly inward.

Patients willing and able to comply with follow-up requirements and self-evaluations

Exclusion Criteria

I have had my kneecap surgically removed.

I have or had an infection.

Major coronal plane deformity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total knee arthroplasty (TKA) using either the standard of care or ROSA-assisted approaches

1-3 days

In-patient surgery

Post-operative Monitoring

Participants are monitored for perioperative parameters, imaging, and patient-reported outcomes

6 weeks

1-3 days post-op, 6 weeks post-op

Follow-up

Participants are monitored for safety and effectiveness after treatment, including functional outcomes and inflammatory response

1 year

3 months post-op, 1 year post-op

What Are the Treatments Tested in This Trial?

Interventions

• ROSA PSA Parapatellar Approach
• ROSA PSA Subvastus Approach

Trial Overview 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.

How Is the Trial Designed?

Group I: Control Active Control 1 Intervention

Standard of care medial parapetallar approach

Group II: ROSA PSA Parapatellar Approach Active Control 1 Intervention

Arm using the ROSA with PSA and medial parapetallar approach

Group III: ROSA PSA Subvastus Approach Active Control 1 Intervention

Arm using the ROSA with PSA and medial subvastus approach

ROSA PSA Parapatellar Approach is already approved in United States, European Union for the following indications:

Approved in United States as ROSA Knee System for:

• Total knee replacement for osteoarthritis

Approved in European Union as Zimmer Biomet ROSA Knee System for:

• Total knee replacement for osteoarthritis

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Zimmer Biomet

Industry Sponsor

Trials

383

Recruited

67,800+

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

Published Research Related to This Trial

Imageless robotic-assisted total knee arthroplasty (RTKA) resulted in significantly better pain scores and greater range of motion compared to imageless navigated total knee arthroplasty (NTKA) at the 1-year follow-up, based on a study of 50 RTKA and 47 NTKA patients.

Although RTKA had a longer average surgical time, it did not show significant differences in other patient-reported outcomes, complication rates, or limb alignment when compared to NTKA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new robotically assisted technique can improve outcomes of total knee arthroplasty comparing to an imageless navigation system. Mancino, F., Rossi, SMP., Sangaletti, R., et al.[2023]

The ROSA Knee system is a collaborative robotic tool that assists surgeons in total knee arthroplasty (TKA) by improving the accuracy and reproducibility of bone cuts and ligament balancing while keeping the surgeon in control of the procedure.

Early studies using the ROSA system have shown high accuracy in cadaveric models, but there are currently no long-term clinical outcomes available, indicating that while the technology is promising, further research is needed to assess its effectiveness in live surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concepts and techniques of a new robotically assisted technique for total knee arthroplasty: the ROSA knee system. Batailler, C., Hannouche, D., Benazzo, F., et al.[2021]

The ROSA® Knee system is a new robotic platform designed to enhance the precision of bone resections and knee balancing during total knee arthroplasty, while still allowing surgeons to maintain control over the procedure.

Early studies indicate that this robotic system leads to accurate limb alignment and low early revision rates, suggesting it may improve surgical outcomes, although further research on long-term clinical results is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Total Knee Arthroplasty With ROSA® Robotic Technology. Knapp, PW., Nett, MP., Scuderi, GR.[2022]

An expert orthopaedic surgeon requires approximately 70 robotic total knee arthroplasties (raTKAs) to match the operative time of manual total knee arthroplasties (mTKAs), indicating a significant learning curve associated with the ROSA system.

After 73 cases, the surgeon was able to perform raTKAs with similar efficiency to mTKAs, and there were no differences in complication rates between the two surgical methods, suggesting that the ROSA system is safe and effective once mastered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The learning curve to ROSA: cases needed to match the surgery time between a robotic-assisted and a manual primary total knee arthroplasty. Kenanidis, E., Boutos, P., Sitsiani, O., et al.[2023]

The study evaluated the reliability of robotic registration in total knee arthroplasty using the ROSA® robotic system, demonstrating excellent intrarater reliability (average ICCs of 0.952 to 0.975) among three evaluators across various conditions.

Interrater reliability was also high, with ICCs of 0.961 for 'Registration + Gap Assessment' and 0.994 for 'Gap Assessment', indicating that the robotic system provides consistent results regardless of the evaluator or the use of preoperative imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Registration of Bony Landmarks and Soft Tissue Laxity during Robotic Total Knee Arthroplasty is Highly Reproducible. Charette, RS., Sarpong, NO., Weiner, TR., et al.[2022]

Citations

1. zimmerbiomet.com zimmerbiomet.com/content/dam/zb-corporate/en/products/specialties/knee/rosa-knee/5372.1-GLBL-en-rosa-knee-system-2024-clinical-evidence-summary-2025-white-paper.pdf

The ROSA® Knee System 2024 Clinical Evidence Summary Still, early outcomes are promising and Mullaji and Khalifa recently reported superior early functional outcomes when reviewing contemporary ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11734351/

Image-based robotic (ROSA® knee system) total ... This randomized controlled trial evaluates clinical effectiveness of robotic-assisted TKA (ROSA® Knee System, Zimmer Biomet, Montreal, Quebec, ...

3. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-024-05427-y

Image-based robotic (ROSA® knee system) total knee ... This randomized controlled trial evaluates clinical effectiveness of robotic-assisted TKA (ROSA® Knee System, Zimmer Biomet, Montreal, Quebec, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0968016024000255

The ROSA robotic-arm system reliably restores joint line ... This study has demonstrated that the ROSA® knee system accurately restores joint line height, patella height and posterior condylar offset. No significant ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/os.14055

Comparison of Alignment Accuracy and Clinical Outcomes ... The initial learning curve for the ROSA® knee system can be achieved in 6-11 cases for operative time and has similar 90-day complication rates ...

6. withpower.com withpower.com/trial/robot-assisted-surgery-for-osteoarthritis-ad587

Robot-Assisted Surgery for Osteoarthritis Early studies on the ROSA Knee System suggest it is promising, with precision in surgery and low early revision rates, indicating it is generally safe for use ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352344124001365

Systematic Review Accuracy and Outcomes of a Novel Cut ... The ROSA system is both highly accurate and precise, with fewer outliers when analyzed at various time points, including postoperative standing radiographs.