Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial.

Purpose: The primary aim of the study was to examine stability and alignment after total knee arthroplasty (TKA) using patient-specific instrumentation (PSI) and conventional instrumentation (CI). The hypothesis was that stability and alignment would be better using PSI than CI, 12 months postoperatively. The secondary aim included the evaluation of clinical outcomes after TKA.

Methods: In this prospective randomized controlled trial, 42 patients with knee osteoarthritis received a Genesis II PS prosthesis with either PSI or CI. Patients visited the hospital preoperatively and postoperatively after 6 weeks and 3 and 12 months. To evaluate stability, varus-valgus laxity was determined in extension and flexion using stress radiographs 12 months postoperatively. Three months postoperatively, a long-leg radiograph and CT scan were obtained to measure hip-knee-ankle (HKA) alignment and component rotation. Furthermore, frontal and sagittal alignment of the components, the Knee Society Score, VAS Pain, VAS Satisfaction, Knee injury and Osteoarthritis Outcome score, Patella score (Kujala), University of California Los Angeles activity score, anterior-posterior laxity, (serious) adverse device-related events, and intraoperative complications were reported. The clinical outcomes were compared using independent t tests or non-parametric alternatives, and repeated measurements ANOVA with a significance level of p < 0.05.

Results: No significant differences were found between the two groups regarding stability, HKA angle, and rotational alignment. In four patients, the PSI did not fit correctly on the tibia and/or femur requiring intraoperative modifications. Both groups improved significantly over time on all clinical outcomes, with no significant differences between the groups 12 months postoperatively. The PSI group showed less tibial slope than the patients in the CI group [PSI 2.6° versus CI 4.8° (p = 0.02)]. Finally, the PSI group more frequently received a thinner insert size than the CI group (p = 0.03).

Conclusions: Patients operated with PSI did not differ from CI in terms of stability and alignment. However, in the PSI group ligament releases were more often required intraoperatively. Furthermore, the two methods did not show different clinical results. It seems that the preoperative planning for the PSI facilitates more conservative bone cuts than CI, but whether this is clinically relevant should be investigated. Since PSI is more expensive and time consuming than CI, and does not outperform CI with regard to clinical results, we recommend to use CI.

Level Of Evidence: I.