Robotic-Assisted Knee Replacement for Osteoarthritis

Overseen By Jacqueline Lenahan, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Inflammatory arthropathy, Prior knee surgery, Osteotomy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day (surgery)

86 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a robot can improve outcomes in knee replacement surgery for individuals with severe knee arthritis. The study compares robotic-assisted surgery, specifically using the Navio™ Robotics-assisted Surgical System, with conventional methods to determine which reduces pain and improves knee function more effectively. Individuals with long-standing severe knee arthritis who have not found relief with other treatments might be suitable candidates. Participants will receive the same implants and care, but the surgical technique will differ between groups. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future surgical techniques.

Do I need to stop my current medications for the trial?

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 prior data suggests that the Navio™ Robotics-assisted Surgical System is safe for knee replacement surgery?

Research has shown that the Navio™ Robotics-assisted Surgical System is generally safe for knee surgeries. Studies have found that this system accurately aligns the knee in over 93% of cases, indicating its effectiveness. However, like any medical procedure, complications can occur. Reported issues include small fractures near pin placements, infections, soft tissue injuries, and more blood loss than expected. Although these problems are uncommon, they are important to consider. Overall, the system is well-tolerated, but awareness of these possible side effects is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Navio™ Robotics-assisted Surgical System because it offers a high-tech twist to traditional knee replacement procedures for osteoarthritis. Unlike conventional surgeries, which rely heavily on the surgeon's skill alone, this system uses advanced robotics to enhance precision, potentially leading to better alignment and improved outcomes. The technology promises to make surgeries less invasive and recovery faster, which is a big deal for patients looking to get back on their feet quickly. This approach represents a significant leap forward in how we tackle knee replacements, aiming to improve both patient experiences and long-term joint function.

What evidence suggests that the Navio™ Robotics-assisted Surgical System is effective for total knee replacement surgery?

Research shows that the Navio™ Robotics-assisted Surgical System, which participants in this trial may receive, provides high accuracy for knee replacements. Studies have found it aligns the knee correctly in over 93% of cases. Proper alignment is crucial for better movement and longer-lasting results. Early evidence suggests that robotic assistance can enhance surgical precision compared to traditional methods. While it has proven effective for partial knee replacements, further research is needed to determine its efficacy for total knee replacements. Participants in this trial will be compared to those receiving a conventional, non-robotics-assisted total knee surgical system. ^{2 6 7 8 9}

Who Is on the Research Team?

Herbert John Cooper, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for individuals aged 40-85 with severe knee osteoarthritis who haven't improved after at least 12 weeks of non-surgical treatment. Participants must have a BMI under 40, speak English fluently, and not have had previous open knee surgery or other major knee issues.

Inclusion Criteria

Body mass index (BMI) less than 40.0 kg/m^2

I have tried non-surgical treatments for 12 weeks without improvement.

My knee pain is due to the most severe stage of arthritis.

Exclusion Criteria

I have had swelling or pain in the same knee before due to inflammation.

I have had open knee surgery on the same knee before.

I am willing and able to follow the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either conventional or robotic-assisted total knee arthroplasty

1 day (surgery)

1 visit (in-person)

Post-operative Care

Participants receive standard perioperative care and rehabilitation

6-12 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for clinical, functional, and radiographic outcomes

Up to 2 years

Regular visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Navio™ Robotics-assisted Surgical System

Trial Overview The study compares robotic-assisted total knee replacement using the Navio system to conventional surgery. Both groups receive identical care and implants but differ in surgical technique. Patients will undergo x-rays and complete tests to assess their surgery's success.

How Is the Trial Designed?

Group I: Navio™ Robotics-assisted Surgical System Experimental Treatment 1 Intervention

Navio™ Robotics-assisted Surgical System

Group II: Non robotics-assisted Surgical System Active Control 1 Intervention

Conventional, non-robotics-assisted total knee surgical system

Navio™ Robotics-assisted Surgical System is already approved in United States, European Union for the following indications:

Approved in United States as NAVIO Surgical System for:

• Partial knee replacement
• Total knee replacement

Approved in European Union as NAVIO Surgical System for:

• Partial knee replacement
• Total knee replacement

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Smith & Nephew, Inc.

Industry Sponsor

Trials

176

Recruited

23,500+

Dr. Maria Berkman

Smith & Nephew, Inc.

Chief Medical Officer since 2023

MD from Harvard Medical School

Dr. Deepak Nath

Smith & Nephew, Inc.

Chief Executive Officer since 2022

PhD in Theoretical Mechanics, University of California, Berkeley

Published Research Related to This Trial

In a multicenter clinical trial involving 115 patients, the novel active robotic system for total knee arthroplasty (TKA) demonstrated no pre-defined adverse events, indicating a high level of safety.

The robotic system effectively achieved limb alignment, with only 11.2% of cases showing postoperative alignment more than ±3° from the planned target, suggesting its efficacy in improving surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe and effective use of active robotics for TKA: Early results of a multicenter study. Stulberg, BN., Zadzilka, JD., Kreuzer, S., et al.[2022]

NAVIO robotic-assisted total knee arthroplasty (RATKA) shows comparable short-term outcomes to conventional total knee arthroplasty (CTKA) in terms of early revisions and adverse events, indicating it is a safe surgical option.

While NAVIO RATKA had a longer surgical time (87 minutes vs. 67.6 minutes for CTKA), it also presented a different adverse event profile, with more periprosthetic fractures and persistent wound drainage, suggesting that surgeons should consider these factors when selecting patients for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NAVIO RATKA shows similar rates of hemoglobin-drop, adverse events, readmission and early revision vs conventional TKA: a single centre retrospective cohort study. Vandenberk, J., Mievis, J., Deferm, J., et al.[2023]

The 'Skywalker' robot-assisted surgical system demonstrated high precision in total knee arthroplasty (TKA), with cutting jig movements limited to less than 0.25 mm, indicating excellent control during surgery.

The system achieved minimal angle deviations (no more than 1.03°) and resection thickness errors (less than 0.78 mm), suggesting it can significantly enhance the accuracy of osteotomies in knee surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Skywalker' surgical robot for total knee arthroplasty: An experimental sawbone study. Xia, R., Tong, Z., Hu, Y., et al.[2021]

The NAVIO™ robotic system for unicompartmental knee arthroplasty (UKA) has shown a remarkable knee implant survivorship rate of 99.2% after an average follow-up of 2.3 years in a study of 128 patients, indicating its potential effectiveness in improving surgical outcomes.

Only one revision was needed due to soft tissue pain, with no issues related to implant loosening or infection, suggesting that the NAVIO system may enhance the precision of implant positioning and overall patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel handheld robotic-assisted system for unicompartmental knee arthroplasty: surgical technique and early survivorship. Battenberg, AK., Netravali, NA., Lonner, JH.[2020]

In a study of 182 knees, robotic-assisted total knee arthroplasty showed significantly better accuracy in the coronal alignment of femoral and tibial components compared to navigation-assisted surgery, suggesting improved surgical precision.

Robotic-assisted techniques resulted in fewer outliers in tibial coronal alignment, indicating that this method may enhance personalized alignment and potentially lead to better clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic-assisted total knee arthroplasty improved component alignment in the coronal plane compared with navigation-assisted total knee arthroplasty: a comparative study. Omichi, Y., Hamada, D., Wada, K., et al.[2023]

A single surgeon requires approximately 29 robotic-assisted total knee arthroplasty (RA-TKA) cases to achieve a steady-state surgical time, indicating a learning curve for effective use of the Navio surgical system.

The average surgical time decreased by 26%, from 41.8 minutes in the initial cases to 31.1 minutes in later cases, with the most significant time reduction occurring during the 'Review of Intraoperative Plan' step.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The successful implementation of the Navio robotic technology required 29 cases. Bell, C., Grau, L., Orozco, F., et al.[2022]

In a study of 19 patients who underwent unicompartmental knee replacement (UKR) using the NAVIO robotic system, all patients were safely discharged within 24 hours, demonstrating the feasibility of rapid discharge pathways.

There were no post-operative complications or readmissions, and patients showed good recovery with a mean active range of motion of 105.8° at 6 weeks and a high median Oxford Knee Score of 44 out of 48, indicating effective pain management and rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving discharge within 24 h of robotic unicompartmental knee arthroplasty may be possible with appropriate patient selection and a multi-disciplinary team approach. Sephton, BM., De la Cruz, N., Shearman, A., et al.[2022]

In a study of 33 patients undergoing robot-assisted unicompartmental knee arthroplasty, both NAVIO and MAKO systems showed similar clinical outcomes at 1 year, with no significant differences in Knee Society Score (KSS) and Knee Functional Score (KFS).

The MAKO system demonstrated significantly shorter operative times (82.5 minutes vs. 98 minutes) and less intraoperative blood loss (80 ml vs. 136.3 ml) compared to the NAVIO system, indicating it may be more efficient during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 1-year outcomes between MAKO versus NAVIO robot-assisted medial UKA: nonrandomized, prospective, comparative study. Leelasestaporn, C., Tarnpichprasert, T., Arirachakaran, A., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33511584/

Initial Experience with the NAVIO Robotic-Assisted Total ... The RAS system produced accurate coronal alignment in TKA in more than 93% of cases with no learning curve effect. Our study suggests that this system is ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03317834

NCT03317834 | Navio With Total Knee Arthroplasty The purpose of this study is to demonstrate superior accuracy with the Navio ™ Robotic-assisted Surgical System in achieving desired post-operative ...

3. unchealthappalachian.org unchealthappalachian.org/app/files/public/abf2311c-da7c-4829-add3-f532198855ce/Care%20and%20Treatment/NAVIO_Total_Knee_Patient_Procedure_Guide.pdf

NAVIO robotics-assisted total knee replacement Arthroscopic surgery is often less effective as osteoarthritis progresses. • Partial knee replacement surgery: a procedure that replaces the single damaged.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/rcs.2505

Surgical accuracy and clinical outcomes of image‐free ... We aimed to review our early results using the image-free robotic-assisted technology in knee arthroplasty. Methods. A total of 71 patients ...

5. ctv.veeva.com ctv.veeva.com/study/navio-robotic-versus-conventional-total-knee-arthroplasty

Navio Robotic Versus Conventional Total Knee Arthroplasty The present study will evaluate outcomes of robotic-assisted versus conventional total knee replacement surgery in patients between 40 and 85 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03072459

A Retrospective Study of the Navio Robotic-assisted ... Subjects who had previously received the Navio robotic-assisted surgical system for unilateral knee replacement (UKR) were assessed to determine the 2-year ...

7. goldenortho.com goldenortho.com/navio-total-knee-replacement-surgery/

NAVIO◊ Total Knee Replacement Surgery The NAVIO◊ Surgical System delivers robotics-assisted tools designed to help tailor total knee replacement surgery to your knee's unique shape and motion.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9958158/

Complications and downsides of the robotic total knee ... Complications of the robotic system were pin-hole fracture, pin-related infection, iatrogenic soft tissue and bony injury, and excessive blood loss.

9. nature.com nature.com/articles/s41598-024-53789-4

Comparison of accuracy and early outcomes in robotic total ... This retrospective study included 88 patients (88 knees) who underwent TKA using the NAVIO (40 patients) or ROSA (48 patients) robotic systems.