Affiliations: Department of Orthopaedic Surgery, Teikyo University School of Medicine 2‐11‐1, Kaga, Itabashi‐ku, Tokyo, 173‐8605, Japan | Department of Orthopaedic Surgery, Faculty of Medicine, The University of Tokyo 7‐3‐1, Hongo, Bunkyo‐ku, Tokyo, 113‐0033, Japan | Gunze Ltd., Kyoto Research Institute 1, Ishiburo, Inokurashinmachi, Ayabe, Kyoto, 623‐0051, Japan | Chugai Pharmaceutical Co., Ltd. 1‐9, Kyobashi 2‐chome, Chuo‐ku, Tokyo, 104‐8301, Japan
Note: [] Corresponding author.
Abstract: We developed a poly‐L‐lactide material strengthened by a highpressed extrusion technique. The bending strength of a rod made of that material is higher than that of the same size rods made of poly‐L‐lactide strengthened by drawing technique, which has been used in clinical cases. The purposes of this study were, first to clarify if the initial strength of extrusion‐strengthened poly‐L‐lactide screws is higher than that of draw‐strengthened poly‐L‐lactide screws, and, secondly to investigate the safe torque for driving the screws in clinical usage. In accordance with AO screw design, five kinds of screws were manufactured. In a pull‐out test and a twisting test using a DYRACON® blocks, the strength of the highpressed extrusion‐strengthened poly‐L‐lactide material was also higher than that of the draw‐strengthened poly‐L‐lactide material after milling into screws. In the simulation using minipig bones and the 4.5 mm∅ cortical screws, when the thickness was below 0.5 mm, between 0.5 and 2 mm or over 3 mm, the break locations were in the cortical bone, the thread of the screw and the under head fillet respectively. In the simulation using minipig bones and the 4.0 mm∅ cancellous screws, breakage occurred not on the screws but on the cancellous bone in all screws.
Keywords: Poly‐L‐lactide, biodegradable, implant, mechanical test
