In this study we randomised 140 patients who were due to undergo primary total knee arthroplasty (TKA) to have the procedure performed using either patient-specific cutting guides (PSCG) or conventional instrumentation (CI).
The primary outcome measure was the mechanical axis, as measured at three months on a standing long-leg radiograph by the hip-knee-ankle (HKA) angle. This was undertaken by an independent observer who was blinded to the instrumentation. Secondary outcome measures were component positioning, operating time, Knee Society and Oxford knee scores, blood loss and length of hospital stay.
A total of 126 patients (67 in the CI group and 59 in the PSCG group) had complete clinical and radiological data. There were 88 females and 52 males with a mean age of 69.3 years (47 to 84) and a mean BMI of 28.6 kg/m2(20.2 to 40.8). The mean HKA angle was 178.9° (172.5 to 183.4) in the CI group and 178.2° (172.4 to 183.4) in the PSCG group (p = 0.34). Outliers were identified in 22 of 67 knees (32.8%) in the CI group and 19 of 59 knees (32.2%) in the PSCG group (p = 0.99). There was no significant difference in the clinical results (p = 0.95 and 0.59, respectively). Operating time, blood loss and length of hospital stay were not significantly reduced (p = 0.09, 0.58 and 0.50, respectively) when using PSCG.
The use of PSCG in primary TKA did not reduce the proportion of outliers as measured by post-operative coronal alignment.