What is the efficacy and safety of Velys from Depuy and other robotic-assisted surgery systems, including ROBODOC, MAKO, NAVIO, ROSA, OMNIBot, and Think Surgical's TSolution One, in orthopedic procedures?

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Robotic-Assisted Systems in Orthopedic Surgery: VELYS and Comparative Analysis

VELYS Robotic-Assisted Solution (DePuy Synthes)

The VELYS robotic-assisted system represents a newer-generation platform for total knee arthroplasty that enables precise bone registration and resection through intraoperative planning of anatomical implant placement, with early outcomes showing improved knee function and pain scores at discharge and six weeks, though long-term efficacy data beyond one year remains limited. 1, 2

Technical Capabilities and Approach

  • The VELYS system utilizes advanced technology to accurately collect bony anatomy and the soft tissue envelope of the knee, enabling surgeons to intraoperatively plan anatomical TKA placement while preserving soft tissues to restore functional knee motion 2
  • The robotic-assisted saw delivers precise, accurate, and efficient execution of the implantation plan with reduced manual errors and minimized soft tissue injury compared to conventional methods 1
  • The system accommodates all TKA techniques and alignment philosophies, providing flexibility in surgical approach 2
  • A tibial-femoral approach is utilized for bone registration, landmark acquisition, and resection 1

Clinical Outcomes

  • Early outcome studies demonstrate improvement in knee function and pain with activity at discharge and six weeks postoperatively 2
  • Surgical time is neutral and comparable to experienced surgeons' results with patient-specific balanced TKA using navigation 2
  • Limited one-year cohort data shows favorable outcome scores and high patient satisfaction, though this represents a small patient population 2
  • The system provides more accurate implant positioning with better postoperative range of motion compared to conventional methods 1

Current Evidence Limitations

  • The first cases were performed in late 2020, making this a very recent platform with minimal long-term data 2
  • Long-term advantages beyond one year require further investigation 1
  • No comparative studies exist evaluating VELYS against other robotic platforms or conventional techniques in peer-reviewed literature

Comprehensive Overview of Robotic Systems in Orthopedic Surgery

ROBODOC/TSolution-One (THINK Surgical)

ROBODOC represents the longest-studied robotic platform with over 10 years of follow-up data, demonstrating no improved clinical outcomes compared to conventional TKA despite enhanced radiological precision, making it difficult to justify given unanswered questions about radiation risks, prolonged surgical duration, and cost-effectiveness. 3, 4

System Characteristics

  • Active-autonomous, image-based robotic milling system enabling consistently accurate implant component positioning 3
  • Utilizes preoperative CT-based planning allowing surgeons to create, view, and analyze surgical outcomes in 3D 3
  • Achieves precision through customized distal femoral resection, accurate femoral rotational alignment determination, error minimization, and bone temperature maintenance with robotic milling 3

Clinical Evidence

  • With follow-up exceeding 10 years, no improved clinical outcomes have been demonstrated compared to conventional technique 4
  • Radiological outcomes show improved surgical precision compared to conventional technique 4
  • Complications and revision rates are published without clear differences to conventional TKA 4
  • Questions regarding radiation risks, prolonged surgical duration, and cost-effectiveness remain unanswered 3

MAKO System

MAKO demonstrates favorable short-term clinical and radiographical results for both UKA and TKA with improved surgical precision, though like other platforms, long-term clinical outcome data beyond radiological accuracy remains limited. 4, 5

Clinical Performance

  • Short-term clinical outcomes are available but long-term data is limited 4
  • Radiological outcomes demonstrate improved surgical precision compared to conventional technique 4
  • Complications and revision rates show no clear differences compared to conventional TKA 4
  • For UKA, favorable clinical and radiographical results are obtained at 2-year follow-up 5

Comparative Data

  • In UKA procedures, MAKO shows no significant clinical differences in pain scores (NRS) or functional outcomes (KOOS) compared to NAVIO at 2-year follow-up 5
  • Active range of motion is comparable between MAKO and NAVIO approaches 5
  • Surgical duration and robotic system utilization time are significantly shorter with MAKO compared to NAVIO, likely due to specific technical aspects of each system 5

NAVIO/CORI System

NAVIO provides comparable clinical outcomes to MAKO for UKA at short-term follow-up, though with significantly longer operative times, suggesting the robotic concept itself rather than the specific platform may be the key element for improving outcomes. 4, 5

System Features

  • Radiological outcomes demonstrate improved surgical precision compared to conventional technique when available 4
  • Gap balance assessment is performed differently compared to other systems, leading to heterogeneous outcomes regarding clinical impact 4
  • Learning curve based on operative time is similar to other robotic platforms 4

Comparative Performance

  • Clinical outcomes (NRS, KOOS) and active range of motion are equivalent to MAKO at 2-year follow-up for UKA 5
  • Surgical duration and robotic system time are significantly longer than MAKO, related to specific technical characteristics 5

ROSA System

ROSA has limited published evidence with short-term clinical outcomes available and demonstrated improved radiological precision, but lacks the depth of data necessary for comprehensive evaluation. 4

  • Short-term clinical outcomes are published but limited in scope 4
  • Radiological outcomes show improved surgical precision compared to conventional technique 4
  • Gap balance assessment differs from other systems with heterogeneous outcome relationships 4
  • Learning curve and operative time patterns are similar to other robotic platforms 4

OMNIBOT System

OMNIBOT has minimal published evidence with only radiological outcomes demonstrating improved precision, making it impossible to draw meaningful clinical conclusions. 4

  • Radiological outcomes demonstrate improved surgical precision compared to conventional technique 4
  • Clinical outcome data is extremely limited or absent 4

Critical Analysis and Clinical Implications

Common Findings Across All Platforms

  • All robotic systems demonstrate improved radiological precision and surgical accuracy compared to conventional techniques, but this enhanced precision has not consistently translated into superior clinical outcomes or patient-reported measures 4
  • Learning curves based on operative time are similar across all robotic platforms 4
  • Most systems require longer operative time compared to conventional technique, particularly early in adoption 4
  • Gap balance assessment methodology varies significantly between systems, creating heterogeneous outcomes regarding clinical impact 4

Evidence Quality Concerns

The systematic review evidence reveals that current data regarding each robotic system is diverse in quantity and quality, with each system having unique specificities that must be assessed independently—the generic term "robotic" should not be used for general conclusions. 4

  • ROBODOC is the only system with long-term (>10 years) clinical outcome data 4
  • Most platforms only present short-term clinical outcomes if available at all 4
  • The diversity of systems and their unique features necessitates separate clinical evaluation for each platform 4

Unanswered Questions

  • Radiation exposure risks from CT-based planning systems remain inadequately addressed 3
  • Cost-effectiveness analyses are incomplete across all platforms 3
  • Long-term clinical outcome superiority over conventional techniques is not established for any system 4
  • The relationship between improved radiological precision and actual patient-centered outcomes remains unclear 4

Clinical Decision-Making Algorithm

When considering robotic-assisted orthopedic surgery:

  1. Prioritize conventional TKA/UKA techniques unless specific patient factors justify robotic assistance (complex anatomy, revision surgery, need for precise ligament balancing) 4

  2. If choosing robotic assistance, select based on:

    • Surgeon experience and institutional availability
    • Operative time tolerance (MAKO demonstrates shorter times than NAVIO for UKA) 5
    • Long-term data availability (ROBODOC has longest follow-up but no clinical outcome advantage) 4

  3. For VELYS specifically:

    • Consider only in centers with established robotic experience given the very limited outcome data 1, 2
    • Recognize that evidence is restricted to early outcomes (≤6 weeks) with minimal one-year data 2
    • Understand that long-term advantages remain investigational 1

  4. Avoid robotic assistance when:

    • Conventional technique expertise is well-established
    • Cost constraints are significant
    • Operative time extension is problematic
    • No specific technical challenges exist that would benefit from robotic precision 4

Key Pitfalls to Avoid

  • Do not assume improved radiological precision automatically translates to better clinical outcomes—the evidence consistently shows enhanced accuracy without corresponding improvements in patient-reported measures or functional outcomes 4
  • Avoid adopting newer platforms like VELYS outside of experienced centers given the paucity of long-term data and the need for institutional learning curves 1, 2
  • Do not generalize findings from one robotic system to another—each platform has unique technical features, planning methodologies, and execution strategies that require independent evaluation 4
  • Recognize that prolonged operative times are common across all robotic platforms, particularly during the learning curve, which may increase anesthetic risks and complications 3, 4
  • Be aware that the "concept" of robotic assistance may be more important than the specific system chosen for UKA, as clinical outcomes appear similar between platforms at short-term follow-up 5

References

2
Research

Patient-Specific TKA with the VELYS™ Robotic-Assisted Solution.

Surgical technology international, 2022

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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