Methods

A total of 500 patients from 11 clinics in 6 countries were enrolled into a prospective, multicenter study. All patients were indicated for primary TKA for OA and received components from a single manufacturer. All liners were made from vitamin-E stabilized, highly crosslinked (95 kGy) polyethylene; 54.7% were posterior stabilized (PS) and the remaining were cruciate-retaining.

The Knee Injury and Osteoarthritis Outcome Score (KOOS) was administered at the one-year follow-up visit. The KOOS pain and activities in daily life (ADL) sub-scores were dichotomized and served as the primary outcomes. Dichotomization was done with the patient acceptable symptom state (PASS), defined by previous studies as the value of the PROM above which patients deem their state as acceptable (84.5 points for KOOS pain and 83.0 points for KOOS ADL).

Plain lateral radiographs were taken and assessed for PTS (Figure 1) and PCO (Figure 2). PTS was categorized as above (excessive flexion), within (ideal), or below (extension) the safe zone of 0° − 7° of flexion. PCO increases or decreases of greater than 3mm were compared against no change (≤ 3mm). Each of the two sagittal positioning metrics was tested against the KOOS pain and ADL PASS at one year.