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

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. Participants achieving post-operative leg alignment were categorized by the following procedure types: Unicondylar Knee Arthroplasty (UKA), Total Knee Arthroplasty (TKA), and overall (i.e., both procedures).

The percentage of knees achieving post-operative leg alignment 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. Percentage of knees achieving post-operative leg alignment were categorized by the following procedure types: Unicondylar Knee Arthroplasty (UKA), Total Knee Arthroplasty (TKA), and overall (i.e., both procedures).

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 is to be 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.

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.

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.

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 is 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.

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 tibial angle is the angle obtained from the intersection of a line drawn parallel to the bottom of the tibial base insert and a line through the center of the tibial base and the tibial canal.

Radiographic assessment on antero-posterior (A/P) and lateral (L) views were performed to identify radiographic findings for the presence of radiolucent lines, osteolysis and implant migration. The number of participants with radiographic findings were categorized as one of the following:

• Yes
• No
• Missing

The 2011 Knee Society Score Objective score is completed by the surgeon and assesses the condition of the knee based on factors like pain, alignment, ligament stability, and range of motion. The Objective score ranges from 0 to 100, with a higher score indicating better knee function (i.e., a better outcome).

The 2011 Knee Society Score Function assesses the participant's ability to perform daily activities and is a component of the overall KSS evaluation. The Function score ranges from 0 to 100, with a higher score indicating better function (i.e., a better outcome).

The 2011 Knee Society Score Satisfaction score is a five question 40-point scale completed by the participant. The Satisfaction score ranges from 0 to 40, with a higher score indicating greater satisfaction (i.e., a better outcome).

The Oxford Knee Score (OKS) specifically assesses the patient's perspective following knee arthroplasty surgery to indicate knee function. Total overall scores range from 0 to 48. A score of 0 is the worst possible outcome while a score of 48 indicates the best possible outcome.

The forgotten Joint Score (FJS) consisted of 12 questions with responses recorded using a five-point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". The item scores were summed and linearly transformed to a 0 to 100 scale and then reversed with a high value reflecting the ability of the subject to forget about the replaced knee joint during the activities of daily living. A score of 100 is the best possible outcome (i.e., a high score indicated a better outcome).

The EQ-5D-5L is composed of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The EQ VAS score uses a scale from 0 to 100, with 0 indicating 'the worst health you can imagine' (i.e., a worse outcome) and 100 indicating 'the best health you can imagine' (i.e., a better outcome).

The EQ-5D-5L is composed of the EQ-5D-5L descriptive system (i.e., index score) and the EQ Visual Analogue scale (EQ VAS). The descriptive system is a health-related quality of life score that comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. A score of 1 indicates perfect health-related quality of life and 0 indicates no health-related quality of life (i.e., a higher score is a better outcome). Index scores cannot be greater than 1 but could be less than 0.