Clinical, Functional, and Midterm Survival Analysis on Sigma Curved Plus Ultracongruent Polyethylene Insert in Primary Total Knee Arthroplasty: A Retrospective Study

Background: Posterior-stabilized (PS) total knee arthroplasty (TKA) poses problems such as the need for intercondylar notch bone resection as well as cam and post wear and patella clunk. Owing to its heightened anterior profile, an ultracongruent polyethylene insert prevents the excessive posterior translation of tibia in the case of a deficient or scarified posterior cruciate ligament (PCL). This study aimed to determine whether an ultracongruent insert provides satisfactory clinical and functional outcomes and midterm survival benefits.

Methods: Based on the reviewed medical records of 200 patients, 240 primary TKA cases involving the use of Sigma Curved Plus (DePuy International, Ltd., Leeds, UK) ultracongruent insert were retrospectively enrolled in this study. Follow-up data were used to evaluate the clinical and radiological outcomes and to conduct a Kaplan-Meier survival analysis.

Results: The mean follow-up duration for 224 knees was 5.8 years (range 5-6.5 years). A revision was made due to infection in two patients and due to periprosthetic fractures in two other patients. The mean knee flexion improved from 101.97° ± 9.43° (range 85°-125°) to 125.75° ± 9.58° (range 100°-140°) at the final follow-up. The mean Knee Society score improved from 43.1 ± 9.76 to 88.3 ± 3.2, and the function score improved from 44.95 ± 7.26 to 90.16 ± 3.71. None of the patients showed radiographic loosening of either insert component, but 22 (5%) patients showed radiolucent lines (<2 mm). The Kaplan-Meier analysis showed that the five-year survival of the insert with an endpoint of revision for any reason was 98.1% (confidence interval, CI, 95.7-99.6%).

Conclusion: The Sigma Curved Plus insert showed a low failure rate with good clinical, functional, and midterm survival outcomes in comparison to standard outcomes reported in earlier studies. Further follow-up studies are warranted to determine whether the insert’s performance is maintained in the long term.