Patient-Specific Instrumentation Does Not Affect Rotational Alignment of the Femoral Component and Perioperative Blood Loss in Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial

Proposed aims of patient-specific instrumentation (PSI) for total knee arthroplasty (TKA) are to improve accuracy of component alignment, while reducing blood loss and surgical time. The primary goal of this prospective, randomized, controlled, clinical trial is to verify whether PSI improves the rotational alignment of the femoral component in comparison to conventionally implanted TKA. One-hundred thirty-three consecutive patients were assessed for eligibility. Block randomization was performed to allocated patients in the treatment (PSI) or control group. During hospital stay, surgical times were recorded, and total blood volume loss and estimated red blood cell were calculated. Two months after surgery, a computed tomography of the knee was obtained to measure femoral component rotation to the transepicondylar axis and tibial component slope. Sixty-nine patients were enrolled. PSI did neither result in a significant improvement in femoral component rotation nor result in a reduction of outliers, as compared with conventional instrumentation. No significant improvement in terms of tibial slope, blood loss, total surgical time, and ischemia time could be identified. The number of tibial recuts required in the PSI group was significantly higher than in the control group (P = .0003). PSI does not improve the accuracy of femoral component rotation in TKA in comparison to conventional instrumentation. Moreover, PSI did not appear to influence any of the other variables investigated as secondary goals by this study. The results of this study do not support its routine use during standard TKA. Level I, randomized, controlled trial.