李廣峰 曹烈虎 王思成 尹志峰 曹中華 李全 蘇佳燦
帶線錨釘彈性內(nèi)固定與鎖骨鉤鋼板內(nèi)固定治療肩鎖關(guān)節(jié)脫位的Meta分析
李廣峰1曹烈虎2王思成1尹志峰1曹中華1李全2蘇佳燦2
目的通過Meta分析方法分析帶線錨釘彈性內(nèi)固定與鎖骨鉤鋼板內(nèi)固定方式治療肩鎖關(guān)節(jié)脫位的療效及并發(fā)癥并進(jìn)行比較。方法計(jì)算機(jī)檢索Cochrane Library、PubMed、Medline、Embase、CNKI、VIP等數(shù)據(jù)庫; 手工檢索中文知名骨科雜志的相關(guān)文獻(xiàn)。查閱錨釘內(nèi)固定與鎖骨鉤鋼板內(nèi)固定治療肩鎖關(guān)節(jié)脫位的對照研究。提取各研究中觀測指標(biāo)數(shù)據(jù),運(yùn)用Revman 5.3軟件對其進(jìn)行分析和處理。結(jié)果經(jīng)篩選后最終納入10篇文獻(xiàn),共納入患者602例。Meta分析結(jié)果顯示,兩種方式在療效、優(yōu)良率、肩關(guān)節(jié)疼痛、肩關(guān)節(jié)活動受限、內(nèi)固定物失效、再脫位等術(shù)后并發(fā)癥方面的差異均有統(tǒng)計(jì)學(xué)意義(P <0.05)。結(jié)論 錨釘彈性內(nèi)固定治療肩鎖關(guān)節(jié)脫位的療效和優(yōu)良率均優(yōu)于鎖骨鉤鋼板內(nèi)固定方式。帶線錨釘彈性內(nèi)固定產(chǎn)生肩關(guān)節(jié)疼痛、活動受限、內(nèi)固定物失效、再脫位等并發(fā)癥方面少于鎖骨鉤鋼板內(nèi)固定方式。
錨釘; 鎖骨鉤鋼板; 肩鎖關(guān)節(jié)脫位; Meta分析
肩鎖關(guān)節(jié)脫位為肩部常見損傷之一,多由肩部遭受直接暴力引起,約占全身骨折脫位的6%,占肩部受損的12%[1]。肩鎖關(guān)節(jié)脫位患者常伴有肩鎖韌帶和喙鎖韌帶的完全或不完全斷裂。其致傷原因主要以摔傷為主,國內(nèi)患者以非機(jī)動車摔倒者多見,發(fā)達(dá)國家患者以年輕體育運(yùn)動者多見[2]。關(guān)于肩鎖關(guān)節(jié)脫位的分型,臨床上方法眾多,其中Tossy分類和Rockwood分類法應(yīng)用較為常見[3]。Tossy I、II肩鎖關(guān)節(jié)損傷可行保守治療,療效一般滿意。Tossy Ⅲ型肩鎖關(guān)節(jié)脫位患者肩鎖關(guān)節(jié)完全脫位,伴有肩鎖韌帶、喙鎖韌帶完全斷裂,關(guān)節(jié)穩(wěn)定結(jié)構(gòu)遭到完全破壞[4],保守治療療效差,需行手術(shù)治療[5]。對于Tossy Ⅲ型肩鎖關(guān)節(jié)脫位臨床醫(yī)師比較認(rèn)同內(nèi)固定治療方式[6]。能否重建肩鎖關(guān)節(jié)正常解剖、恢復(fù)肩鎖關(guān)節(jié)功能直接決定了肩鎖關(guān)節(jié)脫位治療的成敗。在達(dá)到該目的的同時(shí)盡量減少手術(shù)并發(fā)癥,減少繼發(fā)創(chuàng)傷性關(guān)節(jié)炎的發(fā)生[7-8],是臨床醫(yī)師不斷追求的目標(biāo)。
肩鎖關(guān)節(jié)脫位的術(shù)后遠(yuǎn)期療效很大程度上取決于內(nèi)固定方式的選擇。臨床上治療肩鎖關(guān)節(jié)脫位的內(nèi)固定方式較多,包括克氏針張力帶固定、鎖骨鉤鋼板內(nèi)固定、錨釘內(nèi)固定、紐扣鋼板內(nèi)固定等。國內(nèi)外研究者對克氏針張力帶固定、鎖骨鉤鋼板內(nèi)固定方式作了大量報(bào)道。近期,錨定重建肩鎖韌帶、喙鎖韌帶進(jìn)行彈性固定治療肩鎖關(guān)節(jié)脫位逐漸增多,但缺乏多中心隨機(jī)對照研究,以致許多研究者觀點(diǎn)不一致。本研究篩選出一些符合納入標(biāo)準(zhǔn)的文獻(xiàn)后,通過Meta分析對鎖骨鉤鋼板及錨釘彈性內(nèi)固定治療肩鎖關(guān)節(jié)脫位的療效和并發(fā)癥作出評價(jià),比較鎖骨鉤鋼板及錨釘固定的療效差異,為臨床合理治療提供一定依據(jù)。
1.納入標(biāo)準(zhǔn):(1)研究對象:確診為單純肩鎖關(guān)節(jié)脫位患者,分型為Tossy Ⅲ型或RockwoodⅢ型以上,需手術(shù)干預(yù)患者。不合并鎖骨骨折、喙突骨折、神經(jīng)血管損傷等,不分年齡、性別、種族。(2)研究類型:能反映鎖骨鉤鋼板及錨釘治療肩鎖關(guān)節(jié)脫位的對照研究,如觀察性研究、病例分析、隨機(jī)對照試驗(yàn)。(3)國內(nèi)外公開發(fā)表的鎖骨鉤鋼板及錨釘治療該疾病的病例對照研究文獻(xiàn),可計(jì)算出OR或RR值。(4)內(nèi)固定方式:單組內(nèi)固定方式為單一內(nèi)固定,多組患者其中兩組各單一采用鎖骨鉤或錨釘內(nèi)固定。(5)報(bào)告指標(biāo):至少包括療效評價(jià)結(jié)果、關(guān)節(jié)功能恢復(fù)、內(nèi)固定失效、再脫位等術(shù)后并發(fā)癥。
2.排除標(biāo)準(zhǔn):(1)無法獲得原始數(shù)據(jù)的文獻(xiàn)。(2)非臨床結(jié)果、術(shù)前術(shù)后測量結(jié)果不完整及動物實(shí)驗(yàn)文獻(xiàn)、尸體力學(xué)實(shí)驗(yàn)。(3)重復(fù)文獻(xiàn)。(4)研究類型:綜述、評論、講座、讀者回信。(5)報(bào)告指標(biāo):不包括療效評價(jià)結(jié)果及相關(guān)術(shù)后并發(fā)癥。
實(shí)驗(yàn)組采用鎖骨鉤鋼板內(nèi)固定方式治療該疾病; 對照組采用錨釘彈性內(nèi)固定方式治療。
(1)療效。(2)并發(fā)癥:肩部疼痛、肩關(guān)節(jié)活動度、內(nèi)固定失效、再脫位、感染等。
檢索公開發(fā)表的關(guān)于鎖骨鉤鋼板及克氏針張力帶治療該疾病療效方面的中英文文獻(xiàn),使用計(jì)算機(jī)檢 索 Cochrane Library、PubMed、Medline、Embase、CNKI、VIP等中英文數(shù)據(jù)庫;手工檢索《中國骨與關(guān)節(jié)損傷》、《中華骨科雜志》、《中華創(chuàng)傷骨科雜志》、《中國矯形外科》、《臨床骨科》等國內(nèi)影響力較高的雜志,檢索中英文。檢索英文數(shù)據(jù)庫使用MeSH及自由詞進(jìn)行檢索:MeSH用acromioclavicular joint dislocation檢索,自由詞用acromioclavicular joint dislocation/acromioclavicular luxation/acromioclavicular dislocation, rivet/anchor, clavicular/hook-plate/clavicular hook plate等進(jìn)行搜索。中文以主題詞搜索:肩鎖關(guān)節(jié)脫位/肩鎖關(guān)節(jié)損傷、鎖骨鉤鋼板、錨釘/鉚釘、對照研究。
由2位研究者獨(dú)立對納入文獻(xiàn)的題目、摘要進(jìn)行篩選,提取記錄數(shù)據(jù),如果意見未能達(dá)成一致,最終由第3位研究者仲裁解決或經(jīng)討論后達(dá)成共識。質(zhì)量評價(jià)按照J(rèn)uni等隨機(jī)對照試驗(yàn)的質(zhì)量評價(jià)標(biāo)準(zhǔn)進(jìn)行分析評價(jià):(1)評價(jià)研究的隨機(jī)方法是否正確,并分析研究的基線相似性,以輔助評價(jià)選擇性偏倚;(2)是否進(jìn)行了分配隱藏,方法是否正確;(3)是否采用盲法;(4)有無失訪、退出、丟失。如果以上4條質(zhì)量評價(jià)標(biāo)準(zhǔn)均滿足且方法學(xué)正確,則該研究存在偏倚的可能性最小,評為A級;如果其中任一條或多條質(zhì)量評價(jià)標(biāo)準(zhǔn)僅為部分滿足(方法不清者),則該研究存在相應(yīng)偏倚的中度可能性,評為B級;如果其中任一條或多條質(zhì)量評價(jià)標(biāo)準(zhǔn)完全不滿足(方法錯誤或未使用),則該研究存在相應(yīng)偏倚的高度可能性,評為C級。
采用Cochrane協(xié)作網(wǎng)提供的RevMan 5.3統(tǒng)計(jì)軟件進(jìn)行分析,對具有臨床同質(zhì)性的資料進(jìn)行Meta分析。當(dāng)異質(zhì)性過大或無法解釋異質(zhì)性來源時(shí),則采用描述性分析。異質(zhì)性檢驗(yàn)采用卡方檢驗(yàn)和I2檢驗(yàn)兩種統(tǒng)計(jì)學(xué)方法,若結(jié)果分別為P <0.01以及I2>50%被認(rèn)為各研究間存在異質(zhì)性,則進(jìn)行亞組分析,以減小異質(zhì)性,若仍存在異質(zhì)性,采用隨機(jī)效應(yīng)模型;若結(jié)果分別為P>0.01以及I2<50%被認(rèn)為各研究間異質(zhì)性較小從而使用固定效應(yīng)模型。用森林圖評估經(jīng)多元校正后的相對風(fēng)險(xiǎn)度,應(yīng)用相應(yīng)的95%置信區(qū)間解釋不同研究間的直接證據(jù)和隨之而來的整體效應(yīng)。通過漏斗圖檢驗(yàn)有無發(fā)表偏倚。
最終納入10篇(表1)相關(guān)研究進(jìn)行Meta分析,均為隨機(jī)對照試驗(yàn)、對照研究、病例分析,共納入患者602例。其中鎖骨鉤鋼板組有296例患者,錨釘組有306例患者,2篇為3種方式內(nèi)固定兩兩比較,8篇為兩種內(nèi)固定治療方式的比較。根據(jù)質(zhì)量評價(jià)標(biāo)準(zhǔn),10篇文章,其中1篇為A級,6篇為B級,3篇為C級。8個研究比較了兩種手術(shù)方式的療效(優(yōu)良率),通過異質(zhì)性檢驗(yàn),異質(zhì)性較大(P=0.14,I2=49%),通過敏感性分析,剔除不適合的1篇文獻(xiàn),再行異質(zhì)性分析。10篇文章描述了術(shù)后并發(fā)癥,同樣進(jìn)行異質(zhì)性分析,發(fā)現(xiàn)異質(zhì)性較大(P=0.06,I2=46%),通過敏感性分析,剔除1篇文獻(xiàn)。
表1 納入研究的10篇文獻(xiàn)的基本情況
共8篇文獻(xiàn)納入該研究,樣本量共計(jì)425例,其中鎖骨鉤鋼板組207 例,錨釘組218 例,各研究間無明顯統(tǒng)計(jì)學(xué)異質(zhì)性(P=0.29,I2=18%)。故采用固定效應(yīng)模型進(jìn)行Meta分析,結(jié)果顯示,RR=1.10,95%CI:1.03~1.17,P=0.004,提示兩種手術(shù)方式的優(yōu)良率差異有統(tǒng)計(jì)學(xué)意義,說明錨釘固定組在療效方面較鎖骨鉤鋼板組療效為好(圖1)。通過漏斗圖評價(jià)文章發(fā)表偏倚,通過圖2可以看出所有文獻(xiàn)均在斜線范圍內(nèi),而且在中線兩邊分配疾病均勻,說明各研究間異質(zhì)性較低,可進(jìn)行合并分析,發(fā)表偏倚低風(fēng)險(xiǎn)較低。
圖2 兩種方案固定后優(yōu)良率漏斗圖
9個研究對兩種手術(shù)方式發(fā)生術(shù)后并發(fā)癥情況作出了比較,根據(jù)統(tǒng)計(jì)學(xué)分析,有1篇文獻(xiàn)數(shù)據(jù)無可比性,納入8篇文獻(xiàn),樣本量共計(jì)492例。其中鎖骨鉤鋼板組有248例患者,錨釘組有244例患者,研究具有統(tǒng)計(jì)學(xué)異質(zhì)性故采用固定效應(yīng)模型進(jìn)行Meta分析,RR=0.19,95% CI:0.11~0.34,P <0.00001, 提示兩種手術(shù)方式在術(shù)后并發(fā)癥方面差異有統(tǒng)計(jì)學(xué)意義,說明錨釘固定組在術(shù)后并發(fā)癥的發(fā)生情況要少于鎖骨鉤鋼板組(圖3)。通過漏斗圖評價(jià)文章發(fā)表偏倚,通過圖4可以看出所有文獻(xiàn)均在斜線范圍內(nèi),而且在中線兩邊分配疾病均勻,說明各研究間異質(zhì)性較低,可進(jìn)行合并分析,發(fā)表偏倚低風(fēng)險(xiǎn)較低。
圖4 兩種內(nèi)固定術(shù)后并發(fā)癥漏斗圖
肩鎖關(guān)節(jié)屬于微動關(guān)節(jié),在肩關(guān)節(jié)各個方向的運(yùn)動中起到不可或缺的作用。肩鎖關(guān)節(jié)骨性結(jié)構(gòu)由鎖骨肩峰端、肩胛骨、肩峰關(guān)節(jié)面構(gòu)成,軟組織構(gòu)成主要有喙鎖韌帶、肩鎖關(guān)節(jié)囊、肩鎖韌帶、肩關(guān)節(jié)周圍三角肌、斜方肌的腱性附著部分等[9]。喙鎖韌帶對維持肩鎖韌帶的穩(wěn)定性至關(guān)重要,肩鎖關(guān)節(jié)脫位時(shí)常伴有喙鎖韌帶、肩鎖韌帶斷裂,手術(shù)治療須對喙鎖韌帶進(jìn)行修復(fù)。
圖3 兩種內(nèi)固定術(shù)后并發(fā)癥森林圖
鎖骨鉤鈦質(zhì)鋼板是AO/ASIF組織依據(jù)肩鎖關(guān)節(jié)的解剖結(jié)構(gòu)及其微動特點(diǎn)設(shè)計(jì)的一種內(nèi)固定材料,剛度相對較大,具有組織相容性好,手術(shù)操作簡單、使用方便、創(chuàng)口小、術(shù)后并發(fā)癥發(fā)生率低等優(yōu)點(diǎn),符合鎖骨S 狀解剖外形,對于鋼板和鎖骨形狀差異較大的患者可適當(dāng)預(yù)彎取得與骨面的良好的貼附。其鉤部可鉤在肩峰的下后,利用鋼板翹撥力量恢復(fù)肩關(guān)節(jié)正常解剖結(jié)構(gòu),為肩鎖關(guān)節(jié)周圍軟組織及韌帶的愈合提供穩(wěn)定無張力的環(huán)境,但鎖骨鉤鋼板置入后,術(shù)后活動時(shí)引起肩峰撞擊致疼痛,肩鎖關(guān)節(jié)為微動關(guān)節(jié),雖然鎖骨鉤鋼板的鉤端在肩峰下方是游離的,可在肩峰孔中滑動,使肩鎖關(guān)節(jié)保持了一定微動,但其作用有限,且長時(shí)間反復(fù)與關(guān)節(jié)摩擦,易產(chǎn)生肩峰下撞擊綜合征,引起疼痛癥狀。文獻(xiàn)報(bào)道,發(fā)生率高達(dá)22.2%[10]。由于鎖骨鉤對肩袖的卡壓造成肩關(guān)節(jié)外展上舉活動受限,鎖骨鉤鋼板需二次手術(shù)取出內(nèi)固定物, 在一定程度上增加了患者的痛苦及醫(yī)療費(fèi)用。
有學(xué)者報(bào)道[11]采用帶線錨釘治療肩鎖關(guān)節(jié)脫位取得滿意效果,其優(yōu)點(diǎn)為:手術(shù)創(chuàng)傷小,重建喙鎖韌帶通過對抗肩鎖關(guān)節(jié)的分離應(yīng)力而起到張力帶的作用,彈性固定更符合生物力學(xué),對恢復(fù)肩鎖關(guān)節(jié)的穩(wěn)定,促進(jìn)喙鎖韌帶在一定張力刺激下愈合具有重要作用。錨釘體積小,組織相容性好,無需二次手術(shù)取出[12]??p線不產(chǎn)生切割應(yīng)力,不破壞肩鎖關(guān)節(jié)面,進(jìn)行彈性固定時(shí),屬于動態(tài)固定,符合肩鎖關(guān)節(jié)這一微動關(guān)節(jié)的生理功能,最大程度保持肩關(guān)節(jié)功能。錨釘使用符合肩鎖關(guān)節(jié)生物力學(xué)要求。上臂外展時(shí),錨釘線固定不妨礙關(guān)節(jié)上下、前后及旋轉(zhuǎn)移位帶來的微動。且不會造成肩峰與肱骨頭間隙變小,從而可使患者早期進(jìn)行各個角度功能鍛煉,預(yù)防肩關(guān)節(jié)周圍韌帶粘連及肌肉萎縮。而且在肩鎖關(guān)節(jié)分離間隙較小,肩鎖韌帶未完全斷裂情況下,不需要修復(fù)喙鎖韌帶時(shí),可應(yīng)用小切口微創(chuàng)植入喙突[13]。對于帶線錨釘把持力和提供的張力的大小是否合適,有報(bào)道[14]指出錨釘對維持關(guān)節(jié)的穩(wěn)定性、彈性性能和模量、軸向剛度均優(yōu)于正常喙鎖韌帶。但對于老年女性患者,尤其伴有嚴(yán)重骨質(zhì)疏松患者,錨釘把持力可能較正常成年人減低,如需加強(qiáng)錨釘力量或修復(fù)韌帶張力,術(shù)中可在喙突及鎖骨鉆孔,雙線合并,增加張力,重建喙鎖韌帶,避免因錨釘拔出致使肩鎖關(guān)節(jié)再次脫位的可能。
本系統(tǒng)評價(jià)所納入的研究樣本量較大,所納入文獻(xiàn)的整體質(zhì)量水平較高,從Meta分析的結(jié)果來看采用錨釘內(nèi)固定方式治療肩鎖關(guān)節(jié)脫位的療效和優(yōu)良率與鎖骨鉤鋼板內(nèi)固定治療方式比較,優(yōu)于鎖骨鉤鋼板治療。術(shù)后產(chǎn)生肩關(guān)節(jié)疼痛、肩關(guān)節(jié)活動受限、內(nèi)固定物失效、再脫位等并發(fā)癥的情況均比采用鎖骨鉤鋼板內(nèi)固定治療方式要少。
因此,與鎖骨鉤鋼板內(nèi)固定方式相比,錨釘彈性內(nèi)固定治療肩鎖關(guān)節(jié)脫位的療效和優(yōu)良率較高,術(shù)后并發(fā)癥較低,由于各個研究報(bào)道的并發(fā)癥不統(tǒng)一,該研究未進(jìn)行進(jìn)一步對并發(fā)癥種類的探討及分析。綜合考慮,采用錨釘治療該疾病要優(yōu)于鋼板內(nèi)固定治療方式,并且其具有切口小、操作簡單、彈性固定利于韌帶重建、術(shù)后并發(fā)癥發(fā)生率低、無需二次手術(shù)取出等優(yōu)點(diǎn)。
各醫(yī)療單位或者醫(yī)師可根據(jù)具體情況選擇,在兩種內(nèi)固定方式均可實(shí)施情況下,建議首先考慮錨釘內(nèi)固定方式。因此,錨釘彈性固定修復(fù)肩鎖關(guān)節(jié)脫位是一種安全有效的手術(shù)方式,值得在臨床廣泛推廣應(yīng)用。
雖然本系統(tǒng)評價(jià)通過檢索國內(nèi)外數(shù)據(jù)庫,同時(shí)也存在局限性,例如受語種限制,僅檢索了中、英文文獻(xiàn),會忽視其他語言的優(yōu)質(zhì)研究,從而導(dǎo)致檢索不全面,造成結(jié)果偏倚。同時(shí),納入文獻(xiàn)的方法學(xué)也可能存在不同程度的局限性,如隨機(jī)化方法偏倚、測量偏倚、實(shí)施偏倚、選擇偏倚、發(fā)表偏倚等。因此,本研究結(jié)果需要收集更多樣本量,開展多中心、高質(zhì)量的隨機(jī)對照試驗(yàn)進(jìn)一步驗(yàn)證。
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Su Jiacan, Email:drsujiacan@163.com
Curative effect comparison analysis of fixation with suture anchor and hook plate for acromioclavicular joint dislocation
Li Guangfeng1,Cao Liehu2, Wang Sicheng1, Yin Zhifeng1, Cao Zhonghua1, Li Quan2,Su Jiacan2.1Department of Orthopaedics ,Shanghai Zhongye Hospital, Shanghai 200941,China;2Deparpment of Orthopaedic Trauma,Changhai Hospital of Second Military Medical University,Shanghai 200433,China
BackgroundAcromioclavicular joint dislocation is one of the common shoulder injuries, mostly caused by direct violence on shoulder. It accounts for about 6% of whole-body fractures and dislocations, and 12% of shoulder injuries. Acromioclavicular dislocation is often accompanied with complete or incomplete rupture of the acromioclavicular ligament and coracoclavicular ligament.This injury is mainly caused by falling. In China, falling from non-motor vehicles is the most common cause of this injury, while in developed countries, this injury is most common in young athletes.Clinically, there are many classifications of acromioclavicular joint dislocation, of which Tossy classification and Rockwood classification are most commonly applied. Tossy type I and type II injury can be treated conservatively and the effect is generally satisfactory. Tossy type III means the complete dislocation of the acromioclavicular joint, accompanied with the complete rupture of acromioclavicular ligament and coracoclavicular ligament and the complete destruction of the stability of joint structure.Surgical treatment is necessary because the conservative treatment is of poor efficacy. Internal fixation treatment is a clinically accepted treatment for Tossy type III dislocation. Whether we can restore the normal anatomy and the function of the acromioclavicular joint directly determines the success or failure of an acromioclavicular joint dislocation treatment. It is always our goal to achieve this purpose while minimizing surgical complications and reducing the occurrence of secondary traumatic arthritis.The long-term postoperative efficacy of acromioclavicular dislocation is largely dependent on the choice of internal fixation. There are many ways of treating acromioclavicular joint dislocation clinically by internal fixation, including Kirschner wire, tension band, clavicle hook plate, suture anchor, button plate and so on. Domestic and foreign researchers have made a lot of reports on Kirschner wire, tension band and hook plate. Recently, reconstruction of acromioclavicular ligament and coracoclavicular ligament by elastic fixation using suture anchor have gradually increased.However, many researchers hold different opinions because of the lack of multi-center randomized controlled trials. In this study, we selected some papers that met the inclusion criteria, evaluated the effect and complication of hook plate and anchored elastic internal fixation for acromioclavicular joint dislocation by meta-analysis. We also compared the difference of treatment effect between clavicular hook plate and suture anchor fixation, providing a basis for rational clinical treatment.Methods(1)The inclusion and exclusion criteria of literature.Inclusion criteria: ①Object: patients diagnosed of acromioclavicular joint dislocation alone, classified as TossyⅢ or RockwoodⅢ or more, surgery intervention needed.②Type of study: control studies which can reflect the treatment of acromioclavicular joint dislocation using the hook plate and suture anchors, such as observational studies, randomized controlled trials and case reports.③Domestic and foreign published papers reporting of randomized controlled trials treated with hook plates and suture anchors, of which OR or RR value can be calculated.④internal fixation: a single group adopt single way of internal fixation; for two groups, each group adopts either way of fixation. ⑤Report indicators: including at least the results of the evaluation of efficacy, joint function recovery and post-complications such as internal fixation failure and re-dislocation.Exclusion criteria: ① literatures unable to obtain the original data; ② non-clinical results, incomplete preoperative and postoperative measurement results, animal experiments and cadaver mechanics experiments; ③ repeated literature;④ type of study: type of research for the review,comments, lectures, readers reply; ⑤ report indicators: not including the results of evaluation and related postoperative complications.(2)Interventions.The study group uses the hook plate to treat this injury, while the controlled group uses the elastic internal fixation.(3)Index of measurement.①Efficacy; ②Complications: shoulder pain, ROM, internal fixation failure, re-dislocation, infection and so on.(4)Searching strategy.We search the Chinese and English literatures discussing the treating efficacy of the clavicular hook plate and the Kirschner wire tension band. We search the Cochrane Library, Pubmed, Medline, Embase, CNKI, VIP and other Chinese and English databases by computer, and "Chinese Orthopedic Surgery", "Clinical Orthopedics”, "Chinese Journal of Orthopedics and Traumatology " and other domestic influential magazines by hand, both in Chinese and English. Search the English databases using MeSH and free words for retrieve: MeSH searched with “acromioclavicular joint dislocation” We use free words like acromioclavicular joint dislocation/acromioclavicular luxation/acromioclavicular dislocation, rivet/anchor, clavicular/hook-plate/clavicular hook plate, etc. Search keywords in Chinese "acromioclavicular dislocation, acromioclavicular joint injury, clavicular hook plate, anchoring/rivet, controlled study".(5)Literature screening and quality evaluation.Two researchers screened the titles and abstracts of the included literature by, and then extracted the recorded data. If they failed to reach an agreement, the final decision was made by the third author or by discussion to reach a consensus. Quality evaluation was based on the standard evaluation on RCT performed by Juni et al. ① evaluate whether the randomized method is correct and analyze the baseline similarity of the study to assist the evaluation of the selective bias; ②whether the distribution is hidden and whether the method is correct; ③ the use of blindness; ④ whether missed,quit, lost. If all four quality evaluation criteria are met and the methodology is correct, the probability of bias in the study is minimal, which ranked as Grade A; if one or more of the criteria is only partially satisfied (the method is unclear), then the study has a medium possibility of bias, which is rated as Grade B. If one or more of the quality evaluation criteria is completely unsatisfied (the method is incorrect or unused), the study has a high possibility of the corresponding bias, which we rate as Grade C.(6)Statistical analysis.Statistical analysis was performed by RevMan 5.3 statistical software, provided by the Cochrane Collaboration Network. to make a meta-analysis of clinical homogeneity data. Descriptive analysis is used when the heterogeneity is too large or the heterogeneity source cannot be explained. Heterogeneity test has two methods: chi-square test and I2test. If P <0.01 and I2>50% we consider there is heterogeneity between the various studies, and then a sub-group analysis was performed to reduce heterogeneity. If it still existed, random effect model was introduced; if P >0.01 and I2<50%, we think there is little heterogeneity between the studies and then we can use the fixed effect model. Using the forest map to assess the relative risk after multiple corrections, we apply the corresponding 95% confidence interval to explain the direct evidence between the different studies and the consequent overall effect. We use a funnel chart to check whether there is a publication bias.ResultsThe basic characteristics and quality evaluation of the included literatures: 10 meta-analyzes were included in the study finally. All of them were randomized controlled trials, controlled studies and case analysis. 602 patients were included totally.There were 296 patients in clavicular hook plate group, 306 patients in anchor group, 2 papers of the comparison between 3 ways of internal fixation, and 8 papers of the comparison between 2 ways of internal fixation. According to the quality evaluation criteria, among the 10 articles, 1 is for the Grade A, 6 are for the Grade B, 3 are for the Grade C. Eight studies compared the efficacy (excellent rate) of the two surgeries, the heterogeneity was largely through heterogeneity tests (P=0.14, I2=49%). We excluded a study after sensitivity analysis and then performed the heterogeneity analysis. Appling the same heterogeneity analysis on the 10 articles described postoperative complications, the heterogeneity was found large (P=0.06, I2=46%). Therefore, we remove a literature through the sensitivity analysis.A systematic review of the efficacy of the two surgeries: 7 articles were included in the study. Totally 425 cases were included in the study. There were 207 cases of clavicular hook plate group and 218 cases of suture anchor group. There was no statistically significance between different groups (P=0.29,I2=18%). Therefore, Meta-analysis was performed using fixed effect model, RR=1.10, 95% CI: 1.03-1.17, P=0.004, suggesting that the difference between the two surgical methods was statistically significant and indicating that the anchor group has a better curative effect over the hook plate group.All the literatures were in the range of slash, and the disease was distributed evenly on both sides of the middle line, indicating that the heterogeneity of each study was low, which could be combined and analyzed and the publication bias was low. Meta-analysis of postoperative complications: 9 studies compared the postoperative complications of the two surgical methods. According to statistical analysis,there is one literature of which data is not comparable, so eight literatures were included. The total sample size is 492. There were 248 patients in the clavicular hook plate group and 244 patients in the suture anchor group. The meta-analysis was performed in fixed model because of the statistical heterogeneity. RR=0.19, 95% CI: 0.11-0.34, P <0.00001, suggesting that there was statistically significance between the two surgical methods in the postoperative complications and indicating the postoperative complications of the anchoring group are less than hook plate group. We evaluated all of the literatures by funnel chart. All of the literatures were in the range of slash and the disease was distributed evenly on both sides of the middle line, indicating that the heterogeneity of each study was low, which could be combined and analyzed and the publication bias was low. Conclusions Compared with hook plates, elastic internal fixation using suture anchors has a better efficacy and excellence rate and lower rate of post-op complications when treating AC dislocation. As the complications are different according to different research, this study didn't further discuss and analyze the types of complications. Generally, suture anchors are better than the hook plates, since it has many advantages such as smaller incision, easy manipulation, elastic internal fixation which is good for tendon reconstruction, (less) post-op complications, no need for a second-time surgery and so on. Different hospitals and doctors can make decisions according to their own conditions. We give priority to suture anchors when both ways of fixation are applicable.
Acromioclavicular separation; Anchor; Clavicular hook plate; Meta-analysis
10.3877/cma.j.issn.2095-5790.2017.03.008
國家自然國際合作基金(8141101156);上海市科委生物醫(yī)藥專項(xiàng)(154119500600)
200941 上海中冶醫(yī)院骨科1;200433 上海,第二軍醫(yī)大學(xué)附屬長海醫(yī)院創(chuàng)傷骨科2
蘇佳燦,Email:drsujiacan@163.com
2016-10-13)
(本文編輯:李靜;英文編輯:陳建海、張曉萌、張立佳)
李廣峰,曹烈虎,王思成,等. 帶線錨釘彈性內(nèi)固定與鎖骨鉤鋼板內(nèi)固定治療肩鎖關(guān)節(jié)脫位的Meta分析[J/CD].中華肩肘外科電子雜志,2017,5(3):199-206.