Clinical trial NCT06305065: Open and Closed Platform Robotic-assisted Versus Conventional Total Knee Arthroplasty
Official title: Open and Closed Platform Robotic-assisted Versus Conventional Total Knee Arthroplasty: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Total Knee Arthroplasty
Keywords: Knee Osteoarthritis
Knee OA
Total Knee Arthroplasty
Robotic-assisted TKA procedure
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Post-operative leg alignment - Hip-knee-ankle axis (HKA axis)
timeFrame: pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery
Secondary outcomes:
measure: Lateral View
timeFrame: pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery
measure: Standard Radiographic Evaluation - Femoral coronal alignment (FCA)
timeFrame: pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery
measure: Standard Radiographic Evaluation - Femoral sagittal alignment (FSA)
timeFrame: pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery
measure: Standard Radiographic Evaluation - Femoral component rotation (FCR)
timeFrame: pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery
measure: Standard Radiographic Evaluation - Tibial coronal alignment (TCA)
timeFrame: pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery
measure: Standard Radiographic Evaluation - Tibial slope
timeFrame: pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery
measure: Standard Radiographic Evaluation - Joint line distance
timeFrame: pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery
measure: Knee Society Score (KSS)
timeFrame: pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery
measure: Oxford Knee Score (OKS)
timeFrame: pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery
measure: HEALTH ECONOMICS/QUALITY OF LIFE - EQ-5D-5L
timeFrame: pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery
measure: Forgotten Joint Score (FJS)
timeFrame: pre-operative visit, day of surgery, 6 weeks, 6 months, and 12 months after surgery
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: