A Retrospective Study Comparing a Patient-specific Design Total Knee Arthroplasty With an Off-the-Shelf Design: Unexpected Catastrophic Failure Seen in the Early Patient-specific Design

Background: Patient-specific design (PSD) total knee arthroplasty implants are marketed to restore neutral mechanical-axis alignment (MAA) and provide better anatomic fit compared with standard off-the-shelf (OTS) total knee arthroplasty designs. The purpose was to compare the Knee Society scores, radiographic outcomes, and complications of PSD and OTS implants. Methods: Retrospective study analyzing PSD and OTS by a single surgeon. Implant design change in PSD occurred during the period of data collection leading to PSD-1 and PSD-2 subgroups. Radiographic data including MAA, femorotibial angle, coronal-tibial angle, tibial slope and patella-sulcus angle, and complications were analyzed. Minimum follow-up was 2 years or until revision, and patients completed Knee Society scores preoperatively and postoperatively at 3, 6, 12, 24 weeks, and final follow-up. Results: There were 136 patients (154 knees), average age (62.76 +/− 8.4 years), and follow-up (3.1 +/− 1.5 years). The groups included PSD-1 (77 knees), PSD-2 (36 knees), and OTS (41 knees). The PSD-2 group had better Knee Society function scores compared with PSD-1 and OTS at all timepoints except final follow-up. PSD-2 had significantly shorter hospital stay (P = 0.000012) and less hemoglobin drop (P = 0.032) compared with PSD-1 and OTS. No differences were observed in MAA (P = 0.349) or final range of motion (P = 0.629) between the 3 groups. PSD-2 had more normal femorotibial angle, coronal-tibial angle, and tibial slope compared with PSD-1 and OTS. Failures requiring revision were 23% (18/77) PSD-1, 0% PSD-2, and 3% (1/35) OTS. Most common modes of failure were tibial subsidence (56%) and polyethylene locking mechanism failure (22%) in PSD-1. Conclusion: Catastrophic failure was seen in the PSD-1 group with tibial subsidence and polyethylene locking mechanism failure. PSD-2 had better early Knee Society function scores, shorter hospital stay, lower hemoglobin drop, radiographic alignment, and no failures compared with PSD-1 and OTS.