Single-use, patient-specific instrumentation technology in knee arthroplasty: a comparative study between standard instrumentation and PSI efficiency system.

Patient-specific instrumentation is a surgical technique that was created to improve the accuracy of implantation, surgical time and workflow in total knee arthroplasty. This study is a single-center, single-surgeon randomized clinical trial. The aim of this work was to evaluate clinical efficacy of PSI versus standard surgical instrumentation in malalignment risk and blood loss reduction. From April 2015 to September 2016, 40 patients for a total of 40 knees were included in the randomization process. Each patient underwent CT scan of the lower limb including hip, knee and ankle joint with the realization of the PSI system and the TKA with Medacta GMK Primary®. Patients were evaluated 1 month after surgery with X-ray and after 2 months with clinical examination and assessment by Knee Society Score (KSS). Blood loss was detected by adding the values calculated in the operative room and the blood loss in the vacuum systems. In the study group, mean value of KSS was 85.2 (IC 95% 81.2-88.5), mean blood loss was 657 ml (IC 95% 580.6-735.4), and mean value of femorotibial angle was 178.8° (IC 95% 178.5-179.3). In the control group, mean value of KSS was 87.2 (IC 95% 85.3-89.4), mean blood loss was 866.5 ml (IC 95% 763.3-972.5), and mean value of femorotibial angle was 178.9°(IC 95% 177.6-180.3). The Student t test detected a significant difference in blood loss between groups (p < 0.05), and no differences were found between KSS. The single-use instrumentation should improve precision, operative time, turnover time, sterilization and maintenance costs and could help to reduce infection risks. Our results confirm only the improvement on reducing blood loss. In our opinion, this technique should be used in selected patients when the surgeon could have some difficulties to perform femoral cuts on coronal plane or when patients need to have a very little blood loss due to other conditions.

RCT Entities:   Population Interventions Outcomes