This prospective randomised controlled double-blind trial compared two types of PFC Sigma total knee replacement (TKR), differing in three design features aimed at improving flexion. The outcome of a standard fixed-bearing posterior cruciate ligament-preserving design (FB-S) was compared with that of a high-flexion rotating-platform posterior-stabilised design (RP-F) at one year after TKR.

The study group of 77 patients with osteoarthritis of the knee comprised 37 men and 40 women, with a mean age of 69 years (44.9 to 84.9). The patients were randomly allocated either to the FB-S or the RP-F group and assessed pre-operatively and at one year post-operatively. The mean post-operative non-weight-bearing flexion was 107° (95% confidence interval (CI) 104° to 110°)) for the FB-S group and 113° (95% CI 109° to 117°) for the RP-F group, and this difference was statistically significant (p = 0.032). However, weight-bearing range of movement during both level walking and ascending a slope as measured during flexible electrogoniometry was a mean of 4° lower in the RP-F group than in the FB-S group, with 58° (95% CI 56° to 60°) versus 54° (95% CI 51° to 57°) for level walking (p = 0.019) and 56° (95% CI 54° to 58°) versus 52° (95% CI 48° to 56°) for ascending a slope (p = 0.044). Further, the mean post-operative pain score of the Western Ontario and McMaster Universities Osteoarthritis Index was significantly higher in the RP-F group (2.5 (95% CI 1.5 to 3.5) versus 4.2 (95% CI 2.9 to 5.5), p = 0.043).

Although the RP-F group achieved higher non-weight-bearing knee flexion, patients in this group did not use this during activities of daily living and reported more pain one year after surgery.