微創(chuàng)閉合復(fù)位全螺紋空心螺釘內(nèi)固定修復(fù)橈骨遠(yuǎn)端骨折穩(wěn)定性研究:隨機(jī)對(duì)照臨床試驗(yàn)方案
發(fā)布時(shí)間:2018-03-18 15:21
本文選題:組織工程 切入點(diǎn):橈骨 出處:《中國(guó)組織工程研究》2017年31期 論文類(lèi)型:期刊論文
【摘要】:背景:恢復(fù)橈骨遠(yuǎn)端骨折穩(wěn)定性傳統(tǒng)的切開(kāi)復(fù)位內(nèi)固定和外固定支架固定法效果均不十分理想。采用微創(chuàng)手術(shù)修復(fù)橈骨遠(yuǎn)端骨折創(chuàng)傷較小,全螺紋空心釘可增加骨折斷端的穩(wěn)定性,有利于腕關(guān)節(jié)功能恢復(fù)。課題組前期研究發(fā)現(xiàn),微創(chuàng)全紋空心螺釘加壓固定治療橈骨遠(yuǎn)端骨折的手術(shù)適用于不穩(wěn)定的橈骨遠(yuǎn)端骨折,骨折累及關(guān)節(jié)面但骨折塊小于等于2塊的患者。目的:試驗(yàn)假設(shè)微創(chuàng)閉合復(fù)位與全螺紋空心螺釘內(nèi)固定修復(fù)橈骨遠(yuǎn)端骨折的穩(wěn)定性更好,更有利于促進(jìn)腕關(guān)節(jié)功能恢復(fù)。方法:以前瞻、隨機(jī)、對(duì)照方法設(shè)計(jì)臨床試驗(yàn)方案,將中國(guó)遼寧沈陽(yáng)醫(yī)學(xué)院附屬中心醫(yī)院骨外科門(mén)診收治的橈骨遠(yuǎn)端骨折患者60例隨機(jī)等分為2組,每組30例,分別為C型臂X射線機(jī)透視輔助微創(chuàng)閉合復(fù)位與全螺紋空心螺釘加壓內(nèi)固定組,常規(guī)切開(kāi)復(fù)位(包括掌側(cè)和背側(cè)切開(kāi))與鎖定鈦板內(nèi)固定組,均固定24周。主要結(jié)局為術(shù)后24周骨折端X射線以及CT檢查;次要結(jié)局為以PRWE問(wèn)卷功能評(píng)分評(píng)估腕關(guān)節(jié)功能,以患者骨折愈合時(shí)間評(píng)估骨折愈合速度,以目測(cè)類(lèi)比評(píng)分變化評(píng)估患者術(shù)后疼痛情況程度。試驗(yàn)在北美臨床試驗(yàn)注冊(cè)中心注冊(cè)(NCT02784678)。試驗(yàn)經(jīng)沈陽(yáng)醫(yī)學(xué)院附屬中心醫(yī)院倫理委員會(huì)批準(zhǔn)。研究符合世界醫(yī)學(xué)會(huì)制定的《赫爾辛基宣言》的要求。討論:研究試圖證明以微創(chuàng)閉合復(fù)位復(fù)合全螺紋空心釘內(nèi)固定方法修復(fù)橈骨遠(yuǎn)端骨折較傳統(tǒng)切開(kāi)復(fù)位內(nèi)固定更有優(yōu)勢(shì),修復(fù)后骨折斷端穩(wěn)定性好,可早期開(kāi)展腕關(guān)節(jié)功能康復(fù)而有利于功能恢復(fù),若試驗(yàn)結(jié)果達(dá)到此目的,將為橈骨遠(yuǎn)端骨折的外科干預(yù)手段提供更合適的選擇。
[Abstract]:Background: the restoration of distal radius fracture stability of traditional open reduction and internal fixation and external fixation effect are not satisfactory. Less trauma fracture by minimally invasive surgical repair of distal radius, can increase the stability of fracture site full thread hollow screw, is conducive to the recovery of wrist function. Previous studies have found that minimally invasive total hollow grain compression screw fixation for the treatment of distal radius fracture surgery for unstable distal radius fractures, fractures involving the articular surface fracture but less than or equal to 2 block patients. Objective: to test the hypothesis of stability better fixation for distal radius fracture with closed reduction of full thread hollow screw, is more conducive to promoting the recovery of the wrist function. Methods: the prospective, randomized, controlled clinical trial design, the center of Liaoning Chinese radius bone hospital outpatient surgery department of the Shenyang Medical College Fracture of the distal 60 cases of patients were randomly divided into 2 groups, 30 cases in each group, respectively C arm X ray fluoroscopy assisted minimally invasive closed reduction with full thread hollow screw fixation group, conventional open reduction (including the palmar and dorsal incision) and locking titanium plate internal fixation group were fixed for 24 weeks. The outcome of X ray and CT examination for the end of fracture after 24 weeks; the secondary outcome was wrist function was evaluated with PRWE questionnaire score of patients with fracture healing time assessment of fracture healing speed, using visual analogue scale assessment of postoperative pain degree. Trial registration registration centers in North America (NCT02784678) approved clinical trials. The test by the Central Hospital Affiliated to Shenyang Medical College research ethics committee. In accordance with the World Medical Association has developed the "Helsinki declaration". Discussion: the study attempts to prove fixed with minimally invasive closed reduction and cannulated screw thread compound Method for repair of distal radius fractures have more advantages than traditional open reduction and internal fixation after fracture repair, good stability, can be carried out early rehabilitation of wrist joint function and is conducive to the recovery of function, if the test results meet this objective, the surgical intervention for fracture of the distal radius to provide a more appropriate choice.
【作者單位】: 沈陽(yáng)醫(yī)學(xué)院附屬中心醫(yī)院骨外科;
【基金】:沈陽(yáng)市衛(wèi)計(jì)委課題~~
【分類(lèi)號(hào)】:R687.3
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本文編號(hào):1630157
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