Five-year results of the Sigma total knee arthroplasty.

The DePuy Sigma total knee arthroplasty (TKA) was introduced in 1997 as a modification of the Press Fit Condylar Knee (PFC) TKA and has been used extensively in the United Kingdom and worldwide. It is the most commonly used TKA in England and Wales, where it accounts for 36% of all primary TKA. The PFC was well established, with reported 10-year survival rates of 93-97%, but this study reports the first 5-year clinical and radiographic follow-up data for the Sigma TKA. Over a 10-month period, 212 Sigma TKAs were performed in 180 patients. Patients were seen at a specialist nurse-led clinic 7 to 10 days before admission and at 6 months, 18 months, 3 years and 5 years after surgery. Data were recorded prospectively at each visit. Radiographs were obtained at the 5-year follow-up appointment. Of 212 knees, 178 (151 patients) were alive at 5 years. Three were lost to follow up. Six knees (3.0%) were revised, five for infection and one underwent change of polyethylene insert at 4.9 years. Five-year survival with an endpoint of revision for any reason was 97.0%; with an endpoint of revision for aseptic failure it was 99.5%. The median American Knee Society knee rating score was 93 out of 100 at 5 years compared with 25 out of 100 at admission. Of 147 radiographs, none showed radiographic loosening of either component. Seventeen (11.6%) showed radiolucent lines. Twenty-eight (19.0%) had alignment outside the range of 7+/-3 degrees valgus. These results suggest that the Sigma TKA gives acceptable clinical results after 5 years. Further follow-up studies are required to see if this performance is maintained in the long term.