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

NCT06305065 | Not Yet Recruiting DMC

• 1 other identifier: 2024.089
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Knee Osteoarthritis; Knee OA; Total Knee Arthroplasty; Robotic-assisted TKA procedure

Outcome Measures

Primary Outcomes (1)

• Post-operative leg alignment - Hip-knee-ankle axis (HKA axis)

  The primary objective of this study is to evaluate the use of open and closed platform robot in TKA procedure in achieving post-operative leg alignment as compared to procedures using conventional manual instruments. The mechanical axis of the lower limb is calculated as the angle between the following two lines: the first line drawn from the centre of the femoral head to the centre of the knee joint, and the second line is drawn from the centre of the knee to the centre of the ankle joint. Record the correct angle in degrees for 'Leg Alignment on Standing long leg X-Ray - Provide angle and select one position Angle (neutral/ varus/ valgus)'. The angular deviation will be measured from the neutral position (180°).

  pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery

Secondary Outcomes (11)

• Lateral View

  pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery

• Standard Radiographic Evaluation - Femoral coronal alignment (FCA)

  pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery

• Standard Radiographic Evaluation - Femoral sagittal alignment (FSA)

  pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery

• Standard Radiographic Evaluation - Femoral component rotation (FCR)

  pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery

• Standard Radiographic Evaluation - Tibial coronal alignment (TCA)

  pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery

Study Arms (3)

KUNWU Navigation TKA procedure

EXPERIMENTAL

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.

Procedure: KUNWU Navigation TKA procedure

CORI Surgical System TKA procedure

EXPERIMENTAL

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.

Procedure: CORI Surgical System TKA procedure

Conventional TKA procedure

ACTIVE COMPARATOR

This group will perform the standard TKA procedure.

Procedure: Conventional TKA procedure

Interventions

KUNWU Navigation TKA procedure 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.

KUNWU Navigation TKA procedure

CORI Surgical System TKA procedure 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).

CORI Surgical System TKA procedure

Conventional TKA procedure 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.

Conventional TKA procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is a suitable candidate for a robotic-assisted TKA procedure
• 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
• Subject is of legal age to consent and considered skeletally mature (≥ 18 years of age at the time of surgery)
• 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.
• Subject plans to be available through two (2) year postoperative follow-up.
• Applicable routine radiographic assessment is possible.

You may not qualify if:

• 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).
• Subject has been diagnosed with post-traumatic arthritis.
• Subject requires bilateral TKA.
• Subject does not understand the language used in the Informed Consent Form.
• Subject does not meet the indication or is contraindicated for TKA according to the specific Smith+Nephew Knee System's Instructions For Use (IFU).
• Subject has active infection or sepsis (treated or untreated).
• Subject is morbidly obese with a body mass index (BMI) greater than 40.
• Subject is pregnant or breast feeding at the time of surgery.
• 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.
• 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).
• 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.
• Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Tim-yun Michael Ong

CONTACT

26364171; michael.ong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Subjects will be randomly assigned to the KUNWU navigational or CORI Surgical System or conventional manual instrumentation groups according to a balanced randomization procedure using a 1:1:1 allocation ratio. To ensure balanced group assignment, a block randomization schedule will be generated. All subjects who sign the ICF and meet all inclusion and exclusion criteria will be randomized in a 1:1:1 randomization allocation ratio. The block size should be sufficiently small to allow approximately equal allocation of subjects in each group should the study be terminated prematurely whilst also being large enough so as the next treatment cannot be guessed. The study is non-blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: Journal reviewers

Locations

HK (1)