Patient-specific instrumentation development in TKA: 1st and 2nd generation designs in comparison with conventional instrumentation

Abstract

Introduction: This study was conducted to determine if the difference in magnetic resonance imaging (MRI)-based 2nd generation patient-specific instrumentation (PSI) design affects post-operative restoration of neutral mechanical alignment in total knee arthroplasty (TKA) compared with the 1st generation PSI design and conventional surgical techniques. In addition, it is aimed at elucidating whether PSI improves surgical efficiency with respect to operating room time, estimated blood loss and the number of instrument trays used intra-operatively.

Materials and methods: We report our experience in TKA using PSI techniques in 234 patients from August 2012 to March 2015. The patients were divided into 1st (n = 64) and 2nd (n = 70) generation PSI design. The control group (n = 100) underwent TKA with the conventional instrument technique.

Results: The mean surgical time was significantly shorter in the 2nd generation PSI design (62.1 ± 12.1 min) than in the control group (80.6 ± 21.7 min; P < 0.001). A mechanical axis malalignment of >3° of the lower limb was observed in 5.7% of the patients in 2nd generation PSI design compared with 26.0% of the control group (P = 0.006). No significant difference in mechanical alignment on post-operative long alignment radiography was found between 20.3% of the patients in 1st generation PSI design and the control group (P = 0.584).

Conclusion: The 1st generation PSI design did not have a shorter surgical time or improved alignment compared with conventional instrumentation (CI). However, the use of the perfectly fitted 2nd generation PSI design was associated with improvements in both of these measurements. This study emphasizes the importance of PSI design in intra-operative and post-operative outcomes of TKA.

Keywords: Design improvement; Patient-specific instrument; Total knee arthroplasty.