DEVIATION FROM NEUTRAL MECHANICAL ALIGNMENT DOES NOT CORRELATE WITH IMPLANT MIGRATION AT ONE YEAR

Introduction Debate over appropriate alignment in total knee arthroplasty has become a topical subject as technology allows planned alignments that differ from a neutral mechanical axis. These surgical techniques employ patient-specific cutting blocks derived from 3D reconstructions of pre-operative imaging, commonly MRI or CT. The patient-specific OtisMed system uses a detailed MRI scan of the knee for 3D reconstruction to estimate the kinematic axis, dictating the cutting planes in the custom-fit cutting blocks machined for each patient [1, 2]. The purpose of this study was to evaluate the correlation between post-operative limb alignment and implant migration in subjects receiving shape match derived kinematic alignment. Methods In a randomized controlled trial comparing patient-specific cutting blocks to navigated surgery, seventeen subjects in the patient specific group had complete 1 year data. They received cruciate retaining cemented total knee replacements (Triathlon, Stryker) using patient-specific cutting blocks (OtisMed custom-fit blocks, Stryker). Intra-operatively, 6–8 tantalum markers (1 mm diameter) were inserted in the proximal tibia. Radiostereometric analysis (RSA) [3, 4] exams were performed with subjects supine on post-operative day 1 and at 6 week, 3, 6, and 12 month follow-ups with dual overhead tubes (Rad 92, Varian Medical Systems, Inc., Palo Alto, CA, USA), digital detectors (CXDI-55C, Canon Inc., Tokyo, Japan), and a uniplanar calibration box (Halifax Biomedical Inc., Mabou, NS, Canada). RSA exams were analyzed in Model-based RSA (Version 3.32, RSA core , Leiden, The Netherlands. Post-operative limb alignment was evaluated from weight-bearing long-leg films. Results Post-operative limb alignments ranged from 5 degrees of varus to 5 degrees of valgus. Comparing implant migration to post-operative alignment did not demonstrate a relationship between deviation from neutral mechanical alignment and increased migration (Pearson correlation coefficient = 0.25, P = 0.33) (Figure 1). Conclusions Previous studies have suggested that alignment of greater than 3 degrees from neutral may have adverse effects on implant survivorship [5], but this early data does not suggest increased migration with non-neutral alignment. Continued evaluation with RSA to 2 years will be performed to monitor these subjects over the longer term.