一、 台灣全民健保自 1996 年開始實施，健保資料庫中的次級資料由 各醫療院所的申報檔整理歸檔而得，為保障隱私權，病患、醫師 等個人資料均經轉檔儲存，2007 年起，不同研究主題擷取之資 料，經加密處理後，無法相互串連，進一步落實個人資料保護，
但也同時造成完整擷取研究主題資料的重大困難，加以健保元年
（1996 年）的建檔資料不完整，因此本研究僅能以 1997 至 2004 年之資料為研究之母群體進行分析，此為本研究所受限制之一。
二、 醫療機構上傳申報資料以申請健保給付為目的，有關處置、藥品 及耗材等項次，事涉給付金額多寡，登錄相對確實，而與給付無 關的診斷碼、病患個人資料，登錄不夠確實，導致研究過程中，
難以歸屬分類，進行統計時必須加以排除，造成母群體的部分資 料流失，以國際疾病診斷碼為最多，手術碼次之；此外，因研究 統計所需之變項不包括在申報格式中，無從分析而成為研究限 制，健保資料庫的建檔，以健保申報資料為藍本，囊括的臨床數 據資料有限，加以種種個人隱私的保護措施，部分資料經過轉檔 切割，增加整合難度。病患因素僅能就患者性別、年齡及併發症 之有無對人工關節存活的影響進行探討，其他如職業、生活習 慣、用藥史等影響人工關節存活年限的因素，無法進行深入研 究；醫院與醫師因素僅就醫院評鑑層級及醫師平均年手術量對人 工關節存活的影響進行探討，對影響預後的手術細節如手術方 式、再置換的原因、手術進行時間等因素，都無法從資料庫得知；
諸如手術部位的側別、固定方法、手術進行方式、再置換的原因、
患者過世的死亡檔紀錄等，都會影響存活分析的完整性，必須克 服公家機關如健保局、內政部等繁複的行政程序，才能將資料完 整串連，完成分析，此為本研究所受限制之二。
三、 引發人工關節失效的各種機制，文獻報告多從病患因素、醫院與 醫師因素及植入物因素等三個面向進行探討。植入物因素包括人 工關節的設計、材質及固定方式等，則因人工關節的廠牌、型式 的登錄不在健保次級資料庫中而難以進行探討，必須進一步串連 健保局其他資料檔，才能做完整分析。此為本研究所受限制之三。
四、 國際疾病的手術編碼，僅針對主要處置步驟，做原則性的概括分 類，與實際的臨床處置，無法呈現一對一的對應，容易造成資料 庫解讀上的爭議，例如髓芯減壓術，必須以 ICD-op code 77.65 股骨病灶或組織局部切除術定義之，醫師與編碼人員共識程度的 高低，影響輸入資料的正確性；在如髖關節再置換 ICD-op code 81.53 髖關節再置換術，只要更換人工髖關節元件的任何健保申 報碼，資料庫的歸檔都是 81.51，從健保資料庫無從辨識人工關 節的失敗部位，影響存活分析的精確度與完整性。此為本研究所 受限制之四。
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