Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation

The Knee Society Score (KSS) is a clinician-completed questionnaire and consists of two sub-scores: an Objective score assessing pain, range of motion, anteroposterior and mediolateral stability, along with deductions for higher than normal flexion contracture, extension lag and/or varus/valgus alignment, and a Function score, assessing walking on level ground and walking up and down stairs, along with deductions for support. Each sub-score can range from 0 to 100 points, with higher scores corresponding to better outcomes, classified as Excellent: 80 - 100 points; Good: 70 - 79 points; Fair: 60 - 69 points; Poor: \< 60 points.

Time frame: 2 years

The Knee Society Score (KSS) is a clinician-completed questionnaire and consists of two sub-scores: an Objective score assessing pain, range of motion, anteroposterior and mediolateral stability, along with deductions for higher than normal flexion contracture, extension lag and/or varus/valgus alignment, and a Function score, assessing walking on level ground and walking up and down stairs, along with deductions for support. Each sub-score can range from 0 to 100 points, with higher scores corresponding to better outcomes, classified as Excellent: 80 - 100 points; Good: 70 - 79 points; Fair: 60 - 69 points; Poor: \< 60 points.

Time frame: 6 weeks, 6 months, annually until all available study patients have completed two-year follow up evaluation and alternating odd years or as needed thereafter up to 10 years

Population: Numbers of participants for both groups are lower than the enrolled number of patients, especially pre-op. This is because leg extension is not being captured for a lot of pre-op cases, and therefore no score could be calculated.

Assessment of patient x-rays by each site investigator: Radiolucency Femoral Radiolucency is defined as the total nr of participants with radiolucency measured on the femur in each of the 7 different zones. Tibia AP Radiolucency is defined as total nr of participants with radiolucency in each of the 7 zones measured in the AP view X-ray Tibia lateral Radiolucency defined as total nr of participants with radiolucency in each of the 3 zones in the lateral view X-ray Patella Radiolucency is defined as total nr of participants with radiolucency in each of the 5 zones

Time frame: 6 weeks, 6 months, 1, 2, 3, 5, 7 and 10 years postoperative

Population: Note that 7 and 10-years radiographic data is limited, this is because the COVID pandemic was impacting those visits. Therefore, the 7 and 10-years information is limited, and results must be interpreted with care.

Assessment of patient x-rays by each site investigator: Total varus angle. This is defined as the sum of the femoral flexion (the angle between the femoral median axis and the tibial median axis) and the tibial angle (the angle between the anatomical axis of the femur and the tibia in the anteroposterior view of the knee joint) minus 180 degrees.

Time frame: 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years postoperative

Population: Note that 7 and 10-years radiographic data is limited, this is because the COVID pandemic was impacting those visits. Therefore, the 7 and 10-years information is limited, and results must be interpreted with care.

implant survival at 10 years post surgery and is presented by the number of cases with the implants unrevised

Time frame: 10 years

Population: The UK site was closed after 3 year follow-up, and the French site became unresponsive in 2020. This explains the low number of long-term follow-up rate.