Can accuracy with the iASSIST navigation be confirmed by assessment? A multi-center prospective randomized controlled trial with independent three-dimensional image assessment

Abstract

Background: iASSIST is one of the novel accelerometer-based navigation systems for total knee arthroplasty (TKA). Although the accuracy of iASSIST compared with conventional instruments has been reported, such evaluations were performed on two-dimensional (2D) images (X-rays). This multi-center prospective randomized controlled trial aimed to assess component positioning between TKA with and without iASSIST by 3D image assessment, and to clarify whether the iASSIST provides any benefit with regard to alignment accuracy.

Methods: Eighty-three knees with primary knee osteoarthritis were enrolled in this study. iASSIST was used for distal femoral and proximal tibial resection in 42 knees (iA group) and a conventional guide was used in 41 knees (CONV group). At 6 months postoperatively, component alignment was evaluated with 3D images by the independent orthopaedic surgeons, and surgical parameters, range of motion and clinical outcomes were examined.

Results: The rate of knees who have the alignment within 3° of neutral compared with the iA group and CONV group were 92.9% (39/42) vs. 87.8% (36/41) for femur and 76.2% (32/42) vs. 56.1% (23/41) for tibia in the coronal plane, respectively, whereas in the sagittal plane, the rate was 85.7% (36/42) vs. 58.5% (24/41) for femur and 83.3% (35/42) vs. 78.0% (32/41) for tibia, respectively. Compared with the CONV group, the iA group had a significantly improved femoral alignment in the sagittal plane (P = 0.006). There were no clinical or patient-reported differences at 6 months postoperatively.

Conclusions: The iASSIST provides technically high accuracy in femoral resection at TKA compared with a conventional procedure.

Keywords: 3D computed tomography (CT) analysis; Alignment; Computer-assisted surgery; Navigation; Total knee arthroplasty; iASSIST.