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

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment ROSA Knee System for osteoarthritis?

The ROSA Knee System, used in knee surgeries, has shown promising results in improving precision and accuracy during surgery, which can lead to better knee alignment and potentially fewer complications. Early studies suggest it may offer benefits over traditional methods, but more research is needed to confirm its effectiveness for osteoarthritis specifically. ^{1 2 3 4 5}

Is the ROSA Knee System generally safe for use in humans?

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 in humans. ^{1 2 3 4 5}

How is the ROSA Knee System treatment different from other treatments for osteoarthritis?

The ROSA Knee System is unique because it uses a robotic assistant to help surgeons perform knee replacement surgery with high precision and accuracy, which can lead to better alignment and potentially fewer complications compared to traditional methods. ^{1 2 3 4 5}

Research Team

Brent Lanting, MD

Principal Investigator

London Health Sciences Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Registration of Bony Landmarks and Soft Tissue Laxity during Robotic Total Knee Arthroplasty is Highly Reproducible. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Concepts and techniques of a new robotically assisted technique for total knee arthroplasty: the ROSA knee system. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Optimizing Total Knee Arthroplasty With ROSA® Robotic Technology. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

A new robotically assisted technique can improve outcomes of total knee arthroplasty comparing to an imageless navigation system. [2023]

5. France 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. [2023]