This is a binary endpoint in which a knee is either a "success" or "failure".

To obtain a successful radiographic endpoint, a knee must meet the following criteria at the 22+ month interval.

1. Absence of osteolysis
2. No migration/subsidence of any femoral or tibial component
3. Absence of fractured component

Conversely, a radiographic failure is defined as follows:

1. Presence of osteolysis defined as a radiolucency that is both progressive and is greater than 3 mm at its maximum interface in two or more contiguous zones OR a bony destructive lesion that is progressive in nature.
2. Migration/subsidence of any femoral or tibial component defined as a component migration/subsidence of > 3 mm as compared to 6 week radiographs.
3. A component fracture

The analysis was performed on the per protocol population who had a radiographic assessment at the 2+ year follow up interval. The analysis is at the knee level, not participant level (bilateral participants included as two individual knees).

This is a binary endpoint in which a knee is either a "success" or "failure". To obtain a successful result, a knee must reach the 2 year upper window limit with the device intact and without a component revision/removal or a UADE.

The analysis was performed on the per protocol population who had an evaluation at the 2+ year follow up interval. The analysis is at the knee level, not participant level (bilateral participants included as two individual knees).

The Knee Society Assessment Score judges the parameters of pain, stability, and range of motion and flexion contracture, extension lag, and misalignment are deductions. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.

The analysis was performed on the per protocol population who completed the The Knee Society Assessment Score at the 2+ year follow up interval.

The Knee Society Function Score considers walking distance and stair climbing, with deductions for walking aids. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.

The analysis was performed on the per protocol population who completed the The Knee Society Function Score at the 2+ year follow up interval.

The Knee Society Assessment Score judges the parameters of pain, stability, and range of motion and flexion contracture, extension lag, and misalignment are deductions. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.

The analysis was performed on the per protocol population who completed the The Knee Society Assessment Score at each follow-up timepoint. The analysis is at the knee level, not participant level (bilateral participants included as two individual knees). The "Overall Number of Participants Analyzed" is the number of study participants pre-operatively; the "Overall Number of Units Analyzed" refers to the number of knees with data available for analysis at each follow-up timepoint.

The Knee Society Assessment Score judges the parameters of pain, stability, and range of motion and flexion contracture, extension lag, and misalignment are deductions. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.

The analysis was performed on the bilateral subjects in the per protocol population who had a Knee Society Assessment Score at each follow-up timepoint. The analysis is at the knee level, not participant level (bilateral participants included as two individual knees). The "Overall Number of Participants Analyzed" is the number of study participants pre-operatively; the "Overall Number of Units Analyzed" refers to the number of knees with data available for analysis at each follow-up timepoint.

The Knee Society Function Score considers walking distance and stair climbing, with deductions for walking aids. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.

The analysis was performed on the per protocol population who completed the The Knee Society Assessment Score at each follow-up. The analysis is at the knee level, not participant level (bilateral participants included as two individual knees). The "Overall Number of Participants Analyzed" is the number of study participants pre-operatively; the "Overall Number of Units Analyzed" refers to the number of knees with data available for analysis at each follow-up timepoint.

The Knee Society Function Score considers walking distance and stair climbing, with deductions for walking aids. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.

The analysis was performed on the bilateral subjects in the per protocol population who had a Knee Society Function Score at each follow-up timepoint. The analysis is at the knee level, not participant level (bilateral participants included as two individual knees). The "Overall Number of Participants Analyzed" is the number of study participants pre-operatively; the "Overall Number of Units Analyzed" refers to the number of knees with data available for analysis at each follow-up timepoint.

• 12-item self-report measure containing questions regarding the patient's pain and level of function

• The scoring system ranges from 0-4 on each question with 4 representing maximum function and 0 representing poorest function.

• Using this scale, the lowest, worst score is a 0, and the highest, best score is 48.

• The OKS has 2 subscales:

  1. Pain
  2. Function The pain component score (OKS-PCS) consists of items 2, 3, 7, 11 and 12, and the functional component score consists of items 1, 4, 5, 6, 8, 9, and 10.

The analysis was performed on the per protocol population who completed the Oxford Knee Score at each follow-up timepoint. The analysis is at the knee level, not participant level (bilateral participants included as two individual knees). The "Overall Number of Participants Analyzed" is the number of study participants pre-operatively; the "Overall Number of Units Analyzed" refers to the number of knees with data available for analysis at each follow-up timepoint.

This is a binary endpoint in which a knee is either a "success" or "failure".

To obtain a successful radiographic endpoint, a knee must meet the following criteria at the 22+ month interval.

1. Absence of osteolysis
2. No migration/subsidence of any femoral or tibial component
3. Absence of fractured component

Conversely, a radiographic failure is defined as follows:

1. Presence of osteolysis defined as a radiolucency that is both progressive and is greater than 3 mm at its maximum interface in two or more contiguous zones OR a bony destructive lesion that is progressive in nature.
2. Migration/subsidence of any femoral or tibial component defined as a component migration/subsidence of > 3 mm as compared to 6 week radiographs.
3. A component fracture

The analysis was performed on the per protocol population had a radiographic assessment at each follow-up timepoint. The analysis is at the knee level, not participant level (bilateral participants included as two individual knees). The "Overall Number of Participants Analyzed" is the number of study participants at 6 weeks; the "Overall Number of Units Analyzed" refers to the number of knees with data available for analysis at each follow-up timepoint.

At each postoperative assessment using the Analysis Windows, patients were asked to indicate their level of satisfaction with the operated knee. The potential outcomes were Very Satisfied, Satisfied, Uncertain and Unsatisfied.

This analysis is done at the knee-level, not participant level. Bilateral participants were allowed in the study. The "Overall Number of Participants Analyzed" is the number of study subjects analyzed (some with unilateral and some with bilateral knees); the "Overall Number of Units Analyzed" refers to the number of knees analzyed. Also, not every participant returned for every follow-up visit. The "Number Analyzed" in each row/visit below shows the number of knees analyzed at each follow-up.