Abstract
BACKGROUND: Patient-specific instrumentation (PSI) proponents have suggested the benefits of improved component alignment and reduced outliers. In this randomized controlled trial, we attempted to assess the advantage of using PSI over conventional intermedullary (IM) guides for primary total knee arthroplasty (TKA) with bilateral severe femoral bowing (> 5°). A parallel trial design was used with 1:1 allocation. We hypothesize that PSI would support more accurate alignment of components and the lower-limb axis during TKA with severe femoral bowing in comparison with conventional IM guides. METHODS: Among 336 patients undergoing bilateral TKAs due to knee osteoarthritis, 29 patients with bilateral lateral femoral bowing of more than 5° were included in this study. Every patient was assigned randomly to PSI on one side and to conventional instrumentation lateralization of the entry point of the femoral IM guide was applied on the other with a goal of neutral mechanical alignment. The assessment of coronal alignment was completed by measuring the hip-knee-ankle (HKA) angle on preoperative and postoperative long film standing radiographs. Coronal and sagittal orientations of femoral and tibial components were assessed on weight-bearing radiographs. The rotational alignment of the femoral component was evaluated using computed tomography. RESULTS: The postoperative mean ± standard deviation (SD) HKA angle was varus 4.0° (± 2.7°) for conventional technique and varus 4.1° (± 3.1°) for PSI, with no differences between the two groups (p = 0.459). The component orientation showed no significant differences except with respect to the sagittal alignment of the femoral component (p = 0.001), with a PSI mean ± SD flexion of 5.8° (± 3.7°) and a conventional method mean ± SD flexion of 3.2° (± 2.5°), due to the intentional 3° flexion incorporated in the sagittal plane to prevent femoral notching in PSI planning. Computed tomography assessment for rotational alignment of the femoral components showed no difference between the two groups concerning the transepicondylar axis (p = 0.485) with a PSI mean ± SD external rotation of 1.5° (± 1.3°) and conventional mean ± SD external rotation of 1.5° (± 1.6°). CONCLUSION: PSI showed no advantage over lateralization of the femoral entry for IM guidance. LEVEL OF EVIDENCE: 1 TRIAL REGISTRATION: Registered on US national library of medicine ClinicalTrials.gov ( NCT02993016 ) on December 12(th) 2016.