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Int Orthop ; 38(1): 141-7, 2014 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-24305785

RESUMO

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.


Assuntos
Placas Ósseas/economia , Placas Ósseas/normas , Fixadores Internos/economia , Fixadores Internos/normas , Manufaturas/economia , Manufaturas/normas , Custos e Análise de Custo , Países em Desenvolvimento , Fixação Interna de Fraturas/instrumentação , Fraturas Ósseas/cirurgia , Humanos , Teste de Materiais , Controle de Qualidade , Estresse Mecânico , Estados Unidos
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