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

NCT ID: NCT06305065

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2026-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KUNWU Navigation TKA procedure

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.

Group Type: EXPERIMENTAL

KUNWU Navigation TKA procedure

Intervention Type: 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.

CORI Surgical System TKA procedure

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.

Group Type: EXPERIMENTAL

CORI Surgical System TKA procedure

Intervention Type: 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).

Conventional TKA procedure

This group will perform the standard TKA procedure.

Group Type: ACTIVE_COMPARATOR

Conventional TKA procedure

Intervention Type: 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.

Interventions

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.

Intervention Type: 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).

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Subject is a suitable candidate for a robotic-assisted TKA procedure

2. Subject requires a cemented TKA as a primary indication that meets any of the following condition:

• Degenerative joint disease, including osteoarthritis
• Rheumatoid arthritis
• Avascular necrosis
• Requires correction of functional deformity
• Requires treatment of fractures that were unmanageable using other techniques

3. Subject is of legal age to consent and considered skeletally mature (≥ 18 years of age at the time of surgery)

4. Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the Ethical Committee (EC) or Institutional Review Board (IRB) approved informed consent form.

5. Subject plans to be available through two (2) year postoperative follow-up.

6. Applicable routine radiographic assessment is possible.

Exclusion Criteria

1. Subject requires a TKA on the index joint as a revision for a previously failed surgery, or has the need for complex implants, or any other implant than a standard TKA (e.g. stems, augments, or custom made devices).

2. Subject has been diagnosed with post-traumatic arthritis.

3. Subject requires bilateral TKA.

4. Subject does not understand the language used in the Informed Consent Form.

5. Subject does not meet the indication or is contraindicated for TKA according to the specific Smith+Nephew Knee System's Instructions For Use (IFU).

6. Subject has active infection or sepsis (treated or untreated).

7. Subject is morbidly obese with a body mass index (BMI) greater than 40.

8. Subject is pregnant or breast feeding at the time of surgery.

9. Subject, in the opinion of the Investigator, has advanced osteoarthritis or joint disease at the time of surgery and was better suited for an alternate procedure.

10. Subject has a condition(s) that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection).

11. Subject in the opinion of the Investigator has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, intellectual disability, drug or alcohol abuse.

12. Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof. Tim-Yun Michael ONG

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Central Contacts

Tim-yun Michael Ong

Role: CONTACT

michael.ong@cuhk.edu.hk

26364171

Other Identifiers

2024.089

Identifier Type: -

Identifier Source: org_study_id