本文關鍵詞： 智能可調式下肢抬高系統(tǒng) 人工髖關節(jié)置換術 人工全膝關節(jié)置換術 腫脹 疼痛 關節(jié)功能　出處：《南京中醫(yī)藥大學》2015年博士論文　論文類型：學位論文

【摘要】：目的：在實用新型專利“醫(yī)用可調式下肢抬高裝置”的基礎上進一步優(yōu)化,研制“智能可調式下肢抬高系統(tǒng)”,并通過前瞻性臨床隨機對照研究,分析“智能可調式下肢抬高系統(tǒng)”對人工髖、膝關節(jié)置換術后疼痛、腫脹及關節(jié)功能恢復的臨床療效。并建立相應的操作規(guī)程及控制標準。方法：與江蘇魚躍醫(yī)療設備股份有限公司研發(fā)中心合作,對“醫(yī)用可調式下肢抬高裝置”進行重新設計,研制出“智能可調式下肢抬高系統(tǒng)”,達到智能化、可控化、簡便化；評價其臨床有效性與安全性。將2012年3月至2014年12月江蘇省中醫(yī)院、蘇州市中醫(yī)醫(yī)院、無錫市中醫(yī)醫(yī)院骨傷科收治的人工髖、膝關節(jié)置換術的患者各40例,分別隨機分為試驗組和對照組各20例。試驗組采用“智能可調式下肢抬高系統(tǒng)”抬高患肢,對照組采用布朗氏架抬高患肢,治療1d、2d、3d、7d、14d時,觀察兩種裝置對人工髖、膝關節(jié)置換術患者術后引流量、腫脹、腫脹消退時間、疼痛、關節(jié)功能評分、呼叫醫(yī)護人員次數(shù)及并發(fā)癥的影響。在此基礎上形成相應的操作規(guī)程及控制標準。結果：(1)根據(jù)人體參數(shù)的需要,對原“醫(yī)用可調式下肢抬高裝置”的材質、結構參數(shù)、動力元件、運行軌跡等進行了重新優(yōu)化與設計,加入帶有觸摸屏的智能控制系統(tǒng),研制出了集智能性、可調節(jié)性、舒適性、安全性為一體的“智能可調式下肢抬高系統(tǒng)”,能智能化調節(jié)髖、膝、踝關節(jié)活動的角度以及下肢抬高的高度,并制成了試驗樣機投入臨床試驗研究。(2)臨床隨機病例對照試驗表明：人工髖、膝關節(jié)置換術后試驗組在治療1d、2d、3d、7d時的腫脹評分、VAS評分與對照組比較,差別均無統(tǒng)計學意義(P0.05),治療14d時的腫脹評分、VAS評分差別均有統(tǒng)計學意義(P0.05)；人工髖關節(jié)置換術后兩組腫脹消退時間差別有統(tǒng)計學意義(P0.05),人工全膝關節(jié)置換術后兩組腫脹消退時間差別無統(tǒng)計學意義(P0.05)；人工髖關節(jié)置換術后Harris評分及人工全膝關節(jié)置換術后HSS評分在治療全程兩組差別無統(tǒng)計學意義(P0.05)；人工髖、膝關節(jié)置換術后兩組因患肢抬高治療感到不適而呼叫醫(yī)護人員的次數(shù)差別均具有顯著統(tǒng)計學意義(P0.01)兩組發(fā)生并發(fā)癥的例數(shù)差別無統(tǒng)計學意義(P0.05),且均未發(fā)生其他與患肢抬高治療相關的不良反應和并發(fā)癥。(3)制定了適合人工髖、膝關節(jié)置換術后抬高患肢治療的“智能可調式下肢抬高系統(tǒng)”操作規(guī)程與控制標準。(4)“智能可調式下肢抬高系統(tǒng)”臨床應用過程中運行穩(wěn)定,未發(fā)生機械及軟件故障。結論：人工髖、膝關節(jié)置換術后應用“智能可調式下肢抬高系統(tǒng)”抬高患肢治療,在減輕患肢腫脹、疼痛方面,治療1-7d時與對照組無差別,治療14d時優(yōu)于對照組；在改善關節(jié)功能方面,近期療效與對照組相當,且無與患肢抬高治療相關的不良反應,不增加并發(fā)癥的風險,安全性較高。但試驗組智能可控,操作簡便,舒適度高,患者依從性較好。
[Abstract]:Objective: to develop an intelligent adjustable lower extremity raising system based on medical adjustable lower limb raising device, which is a utility patent, and to develop a prospective clinical randomized controlled study. The effect of "intelligent adjustable lower limb elevation system" on pain after hip and knee arthroplasty was analyzed. The clinical curative effect of swelling and joint function recovery. The corresponding operation rules and control standard were established. Methods: in cooperation with the R & D Center of Jiangsu Yuyue Medical equipment Co., Ltd, the "medical adjustable lower limb elevation device" was redesigned. The "intelligent adjustable lower limb elevation system" was developed to achieve intelligence, controllability and simplicity, to evaluate its clinical efficacy and safety. From March 2012 to December 2014, Jiangsu Provincial Hospital of Chinese Medicine, Suzhou Hospital of traditional Chinese Medicine, 40 cases of hip prosthesis and knee arthroplasty were randomly divided into two groups: experimental group (n = 20) and control group (n = 20). The patients in the control group were treated with Brownian's frame raising limb for 14 days. The drainage, swelling, swelling, time of swelling, pain and joint function score of the patients with artificial hip and knee arthroplasty were observed by two kinds of devices after treatment for 1 day, 2 days, 3 days, 7 days and 14 days, respectively. On the basis of this, the corresponding operation rules and control standards were formed. Results according to the needs of human body parameters, the material and structure parameters of the original "medical adjustable lower limb raising device" were analyzed. The power element, running track and so on have been reoptimized and designed, and the intelligent control system with touch screen has been added to develop the intelligent, adjustable and comfortable, The "intelligent adjustable lower limb elevation system", which integrates security, can intelligently adjust the angle of motion of hip, knee and ankle and the elevation of lower extremity. A prototype was made for clinical trial study. (2) A randomized case-control trial showed that the swelling scores and VAS scores of the experimental group were compared with those of the control group at 1 day, 2 days, 3 days and 7 days after artificial hip and knee arthroplasty. There was no significant difference between the two groups in terms of swelling scores and VAS scores after 14 days of treatment. There was significant difference in the time of swelling regression between the two groups after artificial hip arthroplasty, and there was a significant difference between the two groups after total knee arthroplasty. There was no significant difference in swelling regression time (P 0.05), Harris score after hip arthroplasty and HSS score after total knee arthroplasty were not significantly different between the two groups (P 0.05). After knee arthroplasty, there were significant differences in the number of times of call to medical staff due to the discomfort of limb elevation treatment in the two groups (P 0.01). There was no significant difference in the number of complications between the two groups (P 0.05), and there was no significant difference between the two groups in the number of complications, and no other complications were found between the two groups and between the two groups. Limb elevation treatment associated with adverse reactions and complications. After knee arthroplasty, the "intelligent adjustable lower limb elevation system" and its control standard "intelligent adjustable lower limb elevation system" run stably in clinical application. No mechanical or software malfunction occurred. Conclusion: there is no difference between the artificial hip and knee arthroplasty and the control group in reducing the swelling and pain of the affected limb by using the intelligent adjustable lower extremity elevation system after the replacement of the hip and knee joint, and in reducing the swelling and pain of the affected limb, there is no difference between the treatment group and the control group in 1-7 days. After 14 days treatment, the treatment was superior to the control group, and the short-term curative effect was similar to that in the control group, and there were no adverse reactions associated with the treatment of limb elevation, no increase in the risk of complications, and high safety, but the test group was intelligent and controllable. The operation is simple, the comfort is high, the patient compliance is good.
【學位授予單位】：南京中醫(yī)藥大學
【學位級別】：博士
【學位授予年份】：2015
【分類號】：R274.9

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