“智能可调式下肢抬高系统”的研制及在关节置换术后康复的应用研究

发布时间：2018-02-15 03:30

本文关键词： 智能可调式下肢抬高系统人工髋关节置换术人工全膝关节置换术肿胀疼痛关节功能　出处：《南京中医药大学》2015年博士论文　论文类型：学位论文

【摘要】：目的：在实用新型专利“医用可调式下肢抬高装置”的基础上进一步优化,研制“智能可调式下肢抬高系统”,并通过前瞻性临床随机对照研究,分析“智能可调式下肢抬高系统”对人工髋、膝关节置换术后疼痛、肿胀及关节功能恢复的临床疗效。并建立相应的操作规程及控制标准。方法：与江苏鱼跃医疗设备股份有限公司研发中心合作,对“医用可调式下肢抬高装置”进行重新设计,研制出“智能可调式下肢抬高系统”,达到智能化、可控化、简便化；评价其临床有效性与安全性。将2012年3月至2014年12月江苏省中医院、苏州市中医医院、无锡市中医医院骨伤科收治的人工髋、膝关节置换术的患者各40例,分别随机分为试验组和对照组各20例。试验组采用“智能可调式下肢抬高系统”抬高患肢,对照组采用布朗氏架抬高患肢,治疗1d、2d、3d、7d、14d时,观察两种装置对人工髋、膝关节置换术患者术后引流量、肿胀、肿胀消退时间、疼痛、关节功能评分、呼叫医护人员次数及并发症的影响。在此基础上形成相应的操作规程及控制标准。结果：(1)根据人体参数的需要,对原“医用可调式下肢抬高装置”的材质、结构参数、动力元件、运行轨迹等进行了重新优化与设计,加入带有触摸屏的智能控制系统,研制出了集智能性、可调节性、舒适性、安全性为一体的“智能可调式下肢抬高系统”,能智能化调节髋、膝、踝关节活动的角度以及下肢抬高的高度,并制成了试验样机投入临床试验研究。(2)临床随机病例对照试验表明：人工髋、膝关节置换术后试验组在治疗1d、2d、3d、7d时的肿胀评分、VAS评分与对照组比较,差别均无统计学意义(P0.05),治疗14d时的肿胀评分、VAS评分差别均有统计学意义(P0.05)；人工髋关节置换术后两组肿胀消退时间差别有统计学意义(P0.05),人工全膝关节置换术后两组肿胀消退时间差别无统计学意义(P0.05)；人工髋关节置换术后Harris评分及人工全膝关节置换术后HSS评分在治疗全程两组差别无统计学意义(P0.05)；人工髋、膝关节置换术后两组因患肢抬高治疗感到不适而呼叫医护人员的次数差别均具有显著统计学意义(P0.01)两组发生并发症的例数差别无统计学意义(P0.05),且均未发生其他与患肢抬高治疗相关的不良反应和并发症。(3)制定了适合人工髋、膝关节置换术后抬高患肢治疗的“智能可调式下肢抬高系统”操作规程与控制标准。(4)“智能可调式下肢抬高系统”临床应用过程中运行稳定,未发生机械及软件故障。结论：人工髋、膝关节置换术后应用“智能可调式下肢抬高系统”抬高患肢治疗,在减轻患肢肿胀、疼痛方面,治疗1-7d时与对照组无差别,治疗14d时优于对照组；在改善关节功能方面,近期疗效与对照组相当,且无与患肢抬高治疗相关的不良反应,不增加并发症的风险,安全性较高。但试验组智能可控,操作简便,舒适度高,患者依从性较好。
[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.
【学位授予单位】：南京中医药大学
【学位级别】：博士
【学位授予年份】：2015
【分类号】：R274.9

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