Evaluating a robotic system for knee replacement surgery

A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure

This study is testing if a new robotic system for knee replacement surgery can help people have better results and leg alignment compared to traditional methods.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Smith & Nephew, Inc. (industry)
• Locations: 4 sites (Epping and 3 other locations)
• Trial ID: NCT04848896 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of the REAL INTELLIGENCE™ CORI™ robotic system in total knee arthroplasty (TKA) procedures. It compares outcomes of surgeries performed using the CORI system to those using traditional manual instruments, focusing on achieving optimal leg alignment post-surgery. The study will recruit 140 participants across multiple sites in Australia, China, Hong Kong, and New Zealand, with a follow-up period of two years to monitor results.

Who should consider this trial

Good fit: Ideal candidates include adults with osteoarthritis or other degenerative joint diseases requiring total knee arthroplasty.

Not a fit: Patients with inflammatory joint diseases or those not suitable for TKA may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients undergoing knee replacement surgery.

How similar studies have performed: Other studies using robotic assistance in orthopedic surgeries have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Subject is a suitable candidate for a TKA procedure using CORI and a corresponding S+N Knee Implant System.
2. Subject requires a cemented TKA as a primary indication that meets any of the following condition:

   * Non-inflammatory 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 receives simultaneous bilateral UKA OR a unilateral UKA with contralateral TKA.
4. Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:-Contralateral primary TKA or UKA, however, the subject can only have one knee enrolled in this study.
5. Subject does not understand the language used in the Informed Consent Form.
6. Subject does not meet the indication or is contraindicated for TKA according to the specific Smith+Nephew Knee System's Instructions For Use (IFU).
7. Subject has active infection or sepsis (treated or untreated).
8. Subject is morbidly obese with a body mass index (BMI) greater than 40.
9. Subject is pregnant or breast feeding at the time of surgery.
10. 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.
11. Subject currently enrolled in another orthopedic clinical trial study.
12. 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).
13. 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.
14. Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint.
15. Subject is a prisoner or meets the definition of a Vulnerable Subject per International Organization for Standardization (ISO) 14155:2020 Section 3.55.

Where this trial is running

Epping and 3 other locations

• Northern Hospital — Epping, Australia (RECRUITING)
• Jishuitan Hospital, Beijing — Beijing, China (RECRUITING)
• The Prince of Wales Hospital — Shatin, Hong Kong (RECRUITING)
• North Shore Hospital — Auckland, New Zealand (RECRUITING)

Study contacts

• Study coordinator: Jack Cramer

Conditions: Arthroplasty, Replacement, Knee, Osteoarthritis, Total Knee Arthroplasty