Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures

Smith & Nephew, Inc.4 enrolled

Overview

This is a prospective study to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland.

This is a prospective, multi-center, randomized study to demonstrate the safety and effectiveness of CORI. In addition, the study will support regulatory approval by the National Medical Products Administration (NMPA) in China. The study will have two arms, the investigational group will be total knee arthroplasty (TKA) using CORI, the comparison group will be conventional approach with conventional manual instrumentation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-inflammatory Degenerative Joint Disease Osteoarthritis Avascular Necrosis Requires Correction of Functional Deformity Fracture, Knee

Interventions

CORIDEVICE

unicondylar knee arthroplasty (UKA) treated with CORI

ConventionalDEVICE

unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject is a suitable candidate for a UKA procedure using CORI and a compatible S+N Knee implant system. 2. Subject requires a cemented UKA as a primary indication that meets any of the following conditions: 1. Non-inflammatory degenerative joint disease, including osteoarthritis 2. Avascular necrosis 3. Requires correction of functional deformity 4. 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 Ethics Committee (EC) or Institutional Review Board (IRB) approved informed consent form. 5. Subject plans to be available through one (1) year postoperative follow-up. 6. Applicable routine radiographic assessment if possible. Exclusion Criteria: 1. Subject receives a UKA on the index joint as a revision for a previously failed surgery, or need for complex implants, or any other implant than a standard UKA (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 UKA according to specific S+N 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 UKA 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 ISO 14155:2020 Section 3.55.

Locations (3)

Northern Hospital

Epping, Australia

The Prince of Wales Hospital

Shatin, Hong Kong

North Shore Hospital

Auckland, New Zealand

Outcomes

Primary Outcomes

Post-operative Leg Alignment

The number of participants with knees achieving post-operative leg alignment was taken by radiographic assessment at 6 weeks. Post-operative leg alignment was achieved when the deviation from the participant specific target did not exceed ±3 degrees.

Time frame: 6 weeks

Secondary Outcomes

Component Alignment: Femoral Antero-Posterior (A/P) Angle

Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. From the A/P radiograph, the femoral flexion angle in degrees was obtained using standard radiographic tools. Femoral flexion angle is defined as the angle formed between a line across the base of the femoral condyles and a line that is centered along the femoral canal.

Time frame: 6 weeks

Component Alignment: Tibial Antero-Posterior (A/P) Angle

Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. From the A/P radiograph, the tibial angle denotes the angle formed on the medial side of the knee from intersecting lines parallel to the tibial base plate and a line drawn parallel to the tibial canal.

Time frame: 6 weeks

Component Alignment: Total Antero-Posterior (A/P) Valgus Angle

Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. The total valgus angle is the sum of the femoral flexion angle and the tibial angle.

Time frame: 6 weeks

Component Alignment: Lateral View Femoral Flexion Angle

Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. The lateral view femoral flexion angle in degrees was obtained from the intersection of a line from the center of the femoral implant to the top of the femur with a line through the femoral canal. The angle is measured on the proximal side of the intersection.

Data from ClinicalTrials.gov

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