Robotic-Assisted Knee Replacement for Osteoarthritis
Recruiting in Palo Alto (17 mi)
Overseen ByHerbert John Cooper, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Columbia University
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?Total knee replacement surgery is a conventional approach to alleviating the pain and lack of function resulting from arthritis of the knee. While conventional knee replacement surgery is highly successful, incidences of improperly installed replacement parts are not uncommon. To improve outcomes, robotic-assisted total knee replacement surgery has recently become available, and has been shown to be extremely effective for partial knee replacement surgery. However, further research is needed to determine if this same technology can be equally effective for total knee replacement surgery. The present study will evaluate outcomes of robotic-assisted versus conventional total knee replacement surgery in patients between 40 and 85 years old with end stage arthritis of the knee. Other than surgical technique, patients will receive the same operative care and knee replacement implants. In addition to standard x-rays, subjects will be asked to complete several short-term clinical and functional tests and questionnaires to determine outcomes of their surgery.
What data supports the idea that Robotic-Assisted Knee Replacement for Osteoarthritis is an effective treatment?The available research shows that the NAVIO Robotic-Assisted Surgical System is effective for knee replacement. In one study, 128 patients who underwent knee surgery with NAVIO had a high success rate, with 99.2% of knee implants still working well after about 2.3 years. This is better than what is usually seen in other studies. Another study found that NAVIO had similar rates of complications and recovery compared to traditional knee surgery. Additionally, NAVIO was shown to improve the accuracy of implant placement compared to other methods, which can lead to better outcomes for patients.13578
Is the NAVIO Robotics-assisted Surgical System a promising treatment for knee replacement in osteoarthritis?Yes, the NAVIO Robotics-assisted Surgical System is a promising treatment for knee replacement in osteoarthritis. It helps surgeons plan and perform surgeries with high accuracy, leading to better implant positioning and soft tissue balance. Initial results show a high success rate, with 99.2% of knee implants surviving after 2.3 years. This suggests it may be more effective than traditional methods.12478
What safety data is available for robotic-assisted knee replacement using the NAVIO system?The NAVIO robotic-assisted knee replacement system has been evaluated in several studies. One study found that NAVIO RATKA had similar rates of hemoglobin drop, adverse events, readmission, and early revision compared to conventional total knee arthroplasty (TKA). Another study on unicompartmental knee arthroplasty (UKA) with NAVIO reported a 99.2% implant survivorship over a mean follow-up of 2.3 years, with only one revision due to soft tissue pain. Additionally, NAVIO was found to improve component alignment in the coronal plane compared to navigation-assisted TKA. These studies suggest that the NAVIO system is safe and effective, though further long-term data is needed.13678
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications. It's best to consult with the trial coordinators or your doctor for guidance.
Eligibility Criteria
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
I have tried non-surgical treatments for 12 weeks without improvement.
My knee pain is due to the most severe stage of arthritis.
I am between 40 and 85 years old.
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 have a major tear in the ligaments on the inside or outside of my knee.
I have severe joint problems beyond just one knee affecting my movement.
My limb is bent more than 15 degrees from its normal straight position.
I have had surgery to change bone shape or a fracture near a joint.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Navio™ Robotics-assisted Surgical SystemExperimental Treatment1 Intervention
Navio™ Robotics-assisted Surgical System
Group II: Non robotics-assisted Surgical SystemActive Control1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Columbia University Medical CenterNew York, NY
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
Smith & Nephew, Inc.Industry Sponsor
References
A novel handheld robotic-assisted system for unicompartmental knee arthroplasty: surgical technique and early survivorship. [2020]Technology, including robotics, has been developed for use in unicompartmental knee arthroplasty (UKA) to improve accuracy and precision of bone preparation, implant positioning, and soft tissue balance. The NAVIO™ System (Smith and Nephew, Pittsburgh, PA, United States) is a handheld robotic system that assists surgeons in planning implant positioning based on an individual patient's anatomy and then preparing the bone surface to accurately achieve the plan. The surgical technique is presented herein. In addition, initial results are presented for 128 patients (mean age 64.7 years; 57.8% male) undergoing UKA with NAVIO. After a mean of follow-up period of 2.3 years, overall survivorship of the knee implant was 99.2% (95% confidence interval 94.6-99.9%). There was one revision encountered during the study, which was due to persistent soft tissue pain, without evidence of loosening, subsidence, malposition or infection. These initial results suggest a greater survivorship than achieved in the same follow-up time intervals in national registries and cohort studies, though further follow-up is needed to confirm whether this difference is maintained at longer durations.
Achieving discharge within 24 h of robotic unicompartmental knee arthroplasty may be possible with appropriate patient selection and a multi-disciplinary team approach. [2022]Label="AIMS" NlmCategory="OBJECTIVE">There has been significant interest in day-case and rapid discharge pathways for unicompartmental knee replacements (UKR). Robotic-assisted surgery has the potential to improve surgical accuracy in UKR. However, to date there are no published studies reporting results of rapid-discharge pathways in patients receiving UKR using the NAVIO ◊ robotic system.
Comparison of 1-year outcomes between MAKO versus NAVIO robot-assisted medial UKA: nonrandomized, prospective, comparative study. [2020]We have conducted a prospective cohort study with the aim of comparing operative time, intraoperative blood loss, and radiologic and clinical outcomes between imageless (NAVIO) and image-based (MAKO) robot-assisted unicompartmental knee arthroplasty (UKA) for medial compartment osteoarthritis (OA) of the knee.
'Skywalker' surgical robot for total knee arthroplasty: An experimental sawbone study. [2021]Currently, robot-assisted surgical systems are used to reduce the error range of total knee arthroplasty (TKA) osteotomy and component positioning.
The successful implementation of the Navio robotic technology required 29 cases. [2022]Robotic-assisted total knee arthroplasty (RA-TKA) has potential benefits of improved restoration of mechanical alignment, accuracy of bony resection, and balancing. The purpose of this study was to determine the number of cases necessary for a single surgeon to achieve a constant, steady-state surgical time. The secondary purpose was to identify which steps demonstrated the most time reduced. This was a prospective study assessing intraoperative time for 60 RA-TKA with the Navio surgical system. Overall arthroplasty time and duration for each step were recorded. Statistical analysis included a nonlinear regression and survival regression. Successful implementation required 29 cases to achieve a steady-state. The average time decreased from 41.8 min for the first cohort to 31.1 min for the last cohort, a 26% decrease. The step with the greatest reduction was the "Review of Intraoperative Plan" with a reduction of 2.1 min. This study demonstrates surgical times averaging below 60 min and a learning curve that is complete in 29 cases with the surgeon reporting a high level of confidence with the system at 10 cases. Though Navio assisted TKA showed a significantly slower operative time, we are hopeful that future generations of robotic technology will be more efficiently implemented by surgeons.
Safe and effective use of active robotics for TKA: Early results of a multicenter study. [2022]A novel active robotic system for total knee arthroplasty (TKA) performs automated milling of bone surfaces. Study objectives were to assess system safety and effectiveness in a US population.
NAVIO RATKA shows similar rates of hemoglobin-drop, adverse events, readmission and early revision vs conventional TKA: a single centre retrospective cohort study. [2023]Despite widespread adoption of NAVIO robotic-assisted total knee arthroplasty (NAVIO RATKA) in clinical practice, clinical outcome in terms of adverse events and complications remains unclear. The purpose of this study was to compare adverse events, length of stay, surgical time, hemoglobin drop, early readmission rate and revision rate between conventional TKA (CTKA) and NAVIO RATKA.
Robotic-assisted total knee arthroplasty improved component alignment in the coronal plane compared with navigation-assisted total knee arthroplasty: a comparative study. [2023]The purpose of this study was to directly compare implant placement accuracy and postoperative limb alignment between robotic-assisted total knee arthroplasty and navigation-assisted total knee arthroplasty. This retrospective case-control study included a consecutive series of 182 knees (robotic-assisted group, n = 103 knees; navigation-assisted group, n = 79). An image-free handheld robotic system (NAVIO) or an image-free navigation system (Precision N) was used. Component and limb alignment were evaluated on three-dimensional computed tomography scans and full-length standing anterior-posterior radiographs. We compared the errors between the final intraoperative plan and the postoperative coronal and sagittal alignment of the components and the hip-knee-ankle angle between the two groups. The orientation of the femoral and tibial components in the coronal plane were more accurate in the robotic-assisted group than in the navigation-assisted group (p