Mechanical behaviour of low-cost dynamic compression plates correlates with manufacturing quality standards

摘要

Purpose: This study compares the mechanical properties of low-cost stainless steel dynamic compression plates (DCPs) from developing-world manufacturers, adhering to varying manufacturing quality standards, with those of high-cost DCPs manufactured for use in the developed world. Methods: Standard-design ten-hole DCPs from six developing-world manufacturers and high-cost DCPs from two manufacturers in the developed world were studied. Nine plates from each manufacturer underwent mechanical testing: six in four-point monotonic bending to assess strength and stiffness and three in four-point bending fatigue. Statistical comparisons of the group means of monotonic bending test data were made, and a qualitative comparison was performed to assess failures in fatigue. Results: Low-cost DCPs from manufacturers with at least one manufacturing quality standard had significantly higher bending strength and fewer failures in fatigue than did those from low-cost manufacturers with no recognised quality standards. High-cost DCPs demonstrated greater bending strength than did those in both low-cost groups. There were no differences in stiffness and fatigue failure between high-cost DCPs and those low-cost DCPs with quality standards. However, high-cost DCPs were significantly less stiff and had fewer fatigue failures than low-cost DCPs manufactured without such standards. Conclusion: Significant differences were found in the mechanical properties of ten-hole DCP plates from selected manufacturers in the developing and developed worlds. These differences correlated with reported quality certification in the manufacturing process. Mechanical analysis of low-cost implants may provide information useful in determining which manufacturers produce implants with the best potential for benefit relative to cost.