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NCT06838663

Robotic-Assisted Total Knee Arthroplasty: Cruciate-Retaining Versus Bi-Cruciate Stabilized

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

Summary

The global prevalence of osteoarthritis of the knee with total knee arthroplasty performed is projected to substantially rise in the near future. This phenomenon is also observed in Hong Kong in which more than 4000 elective total joint replacement surgeries were performed in 2021 and over 30,000 patients are on the waiting list where some regions would have to wait for a median of more than 4 years. REAL INTELLIGENCE™ CORI™ (CORI Navigation) is a computer-assisted orthopedic surgical navigation and blurring system. CORI Navigation is designed to aid surgeons in planning and executing a procedure involving bone preparation for total knee arthroplasty (TKA) procedures. CORI Navigation 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 Navigation software consists of a patient and user management module, a surgical planner, and an intra-operative cutting module. Bi-Cruciate Stabilized (BCS) total knee arthroplasty (TKA) was designed for more kinematically functional implants that better reconstruct natural knee kinematics for activities of daily living. Surgical implant designs that resect the cruciate ligaments has emerged to simplify implantation and reduce surgical difficulty. The improvement of the biomechanical properties mimicking the natural kinematics of both the BCS and CR TKA may provide an effective solution to patient's dissatisfaction and impaired functional outcomes after surgery.

Official title: Comparative Outcomes of Robotic-Assisted Total Knee Arthroplasty: Cruciate-Retaining (CR) Versus Bi-Cruciate Stabilized (BCS) in a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06

Completion Date

2028-01

Last Updated

2025-06-24

Healthy Volunteers

Conditions

Knee Osteoarthritis Total Knee Arthroplasty

Interventions

PROCEDURE

Robotic assisted Cruciate-Retaining (CR) TKA procedures

Patients who underwent Cruciate Retaining (CR) total knee arthroplasty (TKA)

PROCEDURE

Robotic assisted Bi-Cruciate Stabilized (BCS) TKA procedures

Patients who underwent Bi-Cruciate Stabilized (BCS) total knee arthroplasty (TKA)

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.

Locations (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong