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

Launched by CHINESE UNIVERSITY OF HONG KONG · Feb 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different types of robotic-assisted knee surgeries: one that keeps the knee’s cruciate ligaments (the CR approach) and another that replaces them (the BCR approach). Both methods aim to help people with knee osteoarthritis who need a total knee replacement, which is a common surgery to relieve pain and restore mobility. The trial is important because knee osteoarthritis is becoming more prevalent, and many people are waiting for surgery, sometimes for years. The goal is to see if either surgical approach can lead to better outcomes for patients, like improved movement and satisfaction after surgery.

To participate in this trial, individuals need to be at least 18 years old and meet certain health criteria. They should need a knee replacement due to conditions like osteoarthritis or rheumatoid arthritis, and they must agree to follow the study schedule for two years after the surgery. However, people with certain issues, like a previous failed knee surgery or severe obesity, may not be eligible. If someone joins the trial, they can expect to receive a robotic-assisted knee surgery and have their progress monitored over time to help determine which approach works better for patients.

Gender

ALL

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.