Open and Closed Platform Robotic-assisted Versus Conventional Total Knee Arthroplasty

Summary

REAL INTELLIGENCE™ CORI™ (CORI Surgical System) is a computer-assisted orthopedic surgical system. CORI Surgical System is designed to aid surgeons in planning and executing a procedure involving bone preparation for total knee arthroplasty (TKA) procedures.

CORI Surgical System is comprised of a console control unit, optical tracking camera, primary and secondary input displays (tablet and optional display monitor), and foot pedal. The CORI Surgical System software consists of a patient and user management module, a surgical planner, and an intra-operative cutting module.

Yuanhua Orthopaedic Robotic Systems, KUNWU, is an open-platform robotic system that does not restrict surgeons in choosing the type of prosthesis implant. It is the only Orthopaedic Robotic System in Hong Kong registered with the HK Department of Health Medical Devices Control Office (MDCO) as an open platform system. Unlike other manufacturer's implant-based robots (closed systems), Yuanhua's objective is to provide maximum flexibility in choosing the best implant for each patient. Closed system robots not only impact the surgeon's choice of implant for an individual patient but also affect the hospital's implant purchases over multiple years without any negotiation power on pricing. This business model is often referred to as a "razor and razor blade" model.

The primary objective of this study is to evaluate the use of open and closed platform robotic-assisted TKA procedure in achieving post-operative leg alignment as compared to procedures using standard instruments. The secondary objective of this study is to assess the safety and performance of the robotic-assisted TKA procedure up to 12 months after surgery as compared to procedures using conventional manual instruments.

Conditions

• Knee Osteoarthritis
• Total Knee Arthroplasty

Interventions

PROCEDURE

KUNWU Navigation TKA procedure

In terms of technical specifications, KUNWU is the only robotic arm with seven degrees of freedom, while other systems have a maximum of six. The ergonomic and user-friendly design of the system contributes to physical relief and simplified instrument handling, which enhances surgical precision and reduces cognitive stress. KUNWU's navigation system boasts a refresh rate of 335Hz, which is significantly higher than the current 60Hz rate of other navigation systems. This high refresh rate provides a clear and visually captivating display of the navigation procedure, eliminating blurriness and indecipherable output. It enables surgeons to react promptly during live procedures, enhancing safety for both clinicians and patients and reducing potential complications and hospitalization.

PROCEDURE

CORI Surgical System TKA procedure

The CORI Surgical System (Smith and Nephew®) represents one of such recent advances in robotics that it can assist surgical planning, and increase the accuracy of implant position due to real-time feedback during the procedure (bone resection, implant position, ligamentous balance).

PROCEDURE

Conventional TKA procedure

Total knee arthroplasty (TKA) is a highly successful and frequently performed surgical treatment to reduce disability caused by end-stage osteoarthritis and other conditions affecting articular cartilage. Technical outcomes for TKA are excellent, with favorable postoperative health-related quality of life. Also, survivorship of primary knee replacements is excellent with reported survivorship of 82.3% at 25 years. TKA has traditionally been indicated in the elderly population with relatively sedentary lifestyles, but more active, younger patients (\<55) are receiving TKA due to the desire for a pain-free, active lifestyle with the demand projected to continue to increase for this group. A recent systematic review has shown that functional outcomes are similar in this population compared to elderly patients with no increase in the burden of revision.

Sponsors & Collaborators

• Chinese University of Hong Kong

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-31

Primary Completion

2026-03-31

Completion

2026-05-31

Countries

• Hong Kong

Study Locations