Biomechanical evaluation of shape-memory alloy staples for internal fixation—an in vitro study

BACKGROUND The field of orthopaedics is a constantly evolving discipline. Despite the historical success of plates, pins and screws in fracture reduction and stabilisation, there is a continuing search for more efficient and improved methods of fracture fixation. The aim of this study was to evaluate shape-memory staples and to compare them to a currently used implant for internal fracture fixation. Multi-plane bending stability and interfragmentary compression were assessed across a simulated osteotomy using single and double-staple fixation and compared to a bridging plate. METHODS Transverse osteotomies were made in polyurethane blocks (20 × 20 × 120 mm) and repairs were performed with one (n = 6), or two (n = 6) 20 mm nitinol staples, or an eight-hole 2.7 mm quarter-tubular plate (n = 6). A pressure film was placed between fragments to determine contact area and compressive forces before and after loading. Loading consisted of multi-planar four-point bending with an actuator displacement of 3 mm. Gapping between segments was recorded to determine loads corresponding to a 2 mm gap and residual post-load gap. RESULTS Staple fixations showed statistically significant higher mean compressive loads and contact areas across the osteotomy compared to plate fixations. Double-staple constructs were superior to single-staple constructs for both parameters (p < 0.001). Double-staple constructs were significantly stiffer and endured significantly larger loads before 2 mm gap formation compared to other constructs in the dorsoventral plane (p < 0.001). However, both staple constructs were significantly less stiff and tolerated considerably lower loads before 2 mm gap formation when compared to plate constructs in the ventrodorsal and right-to-left lateral loading planes. Loading of staple constructs showed significantly reduced permanent gap formation in all planes except ventrodorsally when compared to plate constructs. CONCLUSIONS Although staple fixations were not as stable as plate fixations in particular loading planes, double-staple constructs demonstrated the most consistent bending stiffness in all planes. Placing two perpendicular staples is suggested instead of single-staples whenever possible, with at least one staple applied on the compression side of the anticipated loading to improve construct stability.