析出硬化型ステンレス鋼COPの骨関節外科への応用に関する研究

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  • Study on clinical application of a new alloy COP, precipitation hardening stainless steel, as surgical implants
  • セキシュツ コウカガタ ステンレス コウ COP ノ コツカンセツ ゲカ エ

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COP, a new alloy for surgical implants, has been evaluated biologically and clinically for its application to orthopaedic field.<br>1) Biological evaluation<br>a) Tissue culture: Discs 3.5mm in diameter, 1mm in thickness were made with SMo, Vitallium and COP. Also same sized disc was made with copper. The cells used for culture were ME cells (mouse embryonal fibroblasts) in culture passage of the 86th generation. These test discs were sterilized by supersonication, placed in flasks and TD 15 culture bottles, then ME cells were placed in each vessel and cultured separately with these four discs. Citotoxity of the four metals was determined by observing the growth of fibroblasts in the presence of these metals. Vitallium, SMo and COP are found to be noncytotoxic, however copper is found to be highly cytotoxic.<br>b) Experiment with rabbits: Small plates were made with SMo, Vitallium and COP as materials and embedded in dorsal subcutaneous tissue of rabbits. Tissue reactions around these materials were examined with the lapse of time. Kirschner's wire 2mm in diameter was also inserted intramedullaryly into the rabbit femur and similar examinations were carried out. Furthermore, small sections of SMo and COP wires 1mm in length were made, embedded in the rabbit knee joint and similarly examined. The results showed no abnormal findings in the tissues in these three series except for fibrous reactions around materials.<br>2) Clinical evaluation<br>284 AO type plates and 255 Jewett nail-plates which were made with COP have been applied for fracture fixation. Also 250 AOI plates which were made with SMo have been used for the same time of period. From the assessment of fracures healing, bone union in all fracures has been progressed smoothly without any abnormal reactions around metals either SMo or COP. X-ray examination revealed no abnormalities such as abnormal callus formation or bone absorption around the COP material.<br>Therefore it is concluded that trial plates and screws made with COP are excellent and can be extensively used as attested to by experimental and clinical results in comparison with other conventional surgical implants available on the market.

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