Four-Leg Sustained Dynamic Compression Staple and Screw Generates Superior Lapidus Construct as Compared to Plate and Screw: A Biomechanical Study

Abstract

Category: Ankle; Basic Sciences/Biologics Introduction/Purpose: Lapidus procedures are frequently used to treat moderate to severe hallux valgus in the setting of first tarsometatarsal instability or arthritis. The push for early weightbearing can lead to nonunion rates reaching 12%. A growing number of surgeons are utilizing orthopedic staples manufactured from NiTiNOL in foot and ankle arthrodesis procedures. These staples are inserted in an “open expanded” state which enables application of sustained dynamic compression (SDC) between bony segments, which can persist even when challenged with joint settling / bony resorption. The biomechanical performance of these devices has not been quantified in the setting of Lapidus procedures. This study determined the optimum SDC staple construct during Lapidus procedures, and to compare their performance to traditional plate and screw construct in an established model. Methods: Lapidus procedures were performed on synthetic bone replicates (Sawbones) using three SDC staple constructs and one static device construct: (1) dorsal four-leg inline SDC staple, (2) dorsal four-leg inline SDC staple with medial two-leg SDC staple (3) dorsal four-leg inline SDC staple with plantar medial-distal to lateral-proximal cannulated screw and (4) dorsomedial plate and distal dorsal to proximal plantar cannulated screw (FigA). Samples underwent four-point bending with calibrated servo- hydraulic machine (MTS). Max load and construct stiffness was calculated. Interfragmentary contact force, area, and pressure was measured with pressure sensor (Tekscan) and joint plantar gap measurements were completed with 3D motion capture system (Motion Analysis). Testing consisted of stepwise loading to 1, 2, and 3mm of crosshead displacement. For brevity, only data from 3mm displacement test are included herein. Data were analyzed with one-way ANOVA with Dunnett’s post hoc test (N=5/group). Results: The four-leg inline staple + two-leg staple and the four-leg inline staple + screw groups exhibited a 2.5x (p=0.03) and 7.5x (p <.001) increase in joint contact force as compared to the plate + screw group, respectively (FigB). The four-leg inline staple + two-leg staple and the four-leg inline staple + screw groups demonstrated a 3.5x (p=0.002) and 6.6x (p <.001) increase in joint contact area as compared to the plate + screw group, respectively (FigC). The four-leg inline staple + screw group exhibited a 65.1% reduction in plantar gap as compared to the plate + screw group (p=.039, FigD). Conclusion: The four-leg inline staple + screw group exhibited the optimal Lapidus construct biomechanical properties (greatest joint contact force, greatest joint contact area, and least plantar gap). The biomechanical testing performed herein was undertaken to simulate loading akin to early post-operative weight bearing. These data highlight the ability of the four-leg SDC NiTiNOL staple in combination with a static screw to provide meaningfully increased joint compression, uniformity of joint compression, and decreased construct motion as compared to the standard plate + screw construct that is frequently used clinically.