生物可吸收性骨固定裝置於橈骨遠端骨折之臨床治療評估

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Title:	生物可吸收性骨固定裝置於橈骨遠端骨折之臨床治療評估 Clinical Evaluation for the Distal Radius Fractures Treated with Bioresorbable Plates/Screws
Authors:	王麗芬 Wang, Li-Fen
Contributors:	生醫材料暨工程研究所楊正昌
Keywords:	橈骨遠端;骨折;植入物;併發症 distal radius;fracture;implants;complications
Date:	2011-06-21
Issue Date:	2019-06-11 10:56:33 (UTC+8)
Abstract:	在常見的骨折類型中，屬於發生率高之橈骨遠端骨折約佔15%，針對橈骨遠端骨折內、外部固定及植入物之材質選擇上，基於典型對金屬植入物之疑慮，包括如局部疼痛、腐蝕、附近組織的金屬堆積、鈦過敏、干擾影像掃瞄及放射線治療等問題，常需二次手術移除金屬植體。而使以吸收性高分子取代金屬植體將成為發展趨勢，本研究之目的，在以評估手掌生物可吸收性聚合物植入物系統於治療橈骨遠端骨折之功能性及放射性結果。受試者數量為8人，實驗設計上以非盲(Non- blind)試驗，實驗組使用BioTech One公司之吸收性聚乳酸Bonamates®，控制組使用Synthes公司之金屬3.5-mm Volar T locking plates，橈骨遠端骨折固定系統，在有效性上的評估，包括骨釘折斷/鬆弛的發生率、骨頭癒合狀況、功能狀況(握力強度、腕關節動作範圍)、X光片參數；在安全性上進行評估術後併發症的發生率，包括感染、局部疼痛、腐蝕、過敏、腕隧道症候群、手指攣縮、神經損傷、再骨折之評估，並於術後進行為期至少四個月之追蹤觀察。結果，所有的橈骨遠端骨折部位都癒合，一位病人獲得優異的癒合，兩位病人是良好的癒合，一位是普通的癒合；控制組：三位病人是良好的癒合，一位是普通的癒合。所有的病人得到滿意的成果，沒有出現材料相關的感染或過敏。所以，生物可吸收性骨固定裝置是橈骨遠端骨折是一種安全有效的治療方式，但需要手術後適時進行短臂上石膏或夾板固定以保護。 Among common fractures, the incidence of distal radius fractures is over 15%. Many concerns about the metallic implants for distal radius fractures include local pain, corrosion, metal accumulation, titanium allergy, image scanning, and allergies of radiation treatment. Thus, secondary surgery to remove the metal implants is often required. It becomes a trend to use absorbable implants instead of metal one. The purpose of this study is to conduct a clinical assessment for using bioresorbable plates/screws in distal radius fractures. The number of subjects, experimental design, non-blind (Non-blind) test, the experimental group using the BioTech One company polylactic acid absorbable Bonamates®, Control group uses metal 3.5-mm Volar T locking plates, distal radius fracture fixation system of Synthes Company. the validity of the assessment, including nail broken / relaxation occurs rate of bone healing status, functional status (grip strength, wrist range of motion), X-ray parameters; in the security assessment on the incidence of postoperative complications, including infection, local pain, corrosion, allergies, carpal tunnel syndrome, finger contracture, nerve injury, then the assessment of fracture, and in a period of at least four months after the tracking observation. Result: all parts of distal radius fractures showed healing, one patient received excellent healing, two patients is a good healing, a healing of the ordinary. control group: three patients had good healing, the healing of the one is common. All patients had a satisfactory outcome without showing major material-related infection or allergy. Therefore, bioabsorbable bone fixation device for trating distal radius fracture is safe and effective. but requires an appropriate time after the operation immediately on the short arm cast or splint to protect the bivalves.
Description:	碩士指導教授-楊正昌共同指導教授-李勝揚委員-邱方遒
Data Type:	thesis
Appears in Collections:	[Graduate Institute of Biomedical Materials and Tissue Engineering] Dissertation/Thesis

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