台灣捷邁醫療器材股份有限公司

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以前用CoC是為了要有最強的耐磨度,這點現在已經可被CoE取代。在國外,維他命E襯墊的臨床使用已超過13年,除了頂級耐磨與長期抗氧化,更能一舉解決多項臨床問題:

Biolox forte Ceramic-on-Ceramic under microseperation. 2013 Mazen AH et al. J Engineering in Medicine 227(5) 535–542., Internal Testing at Biomet: MT 4555.  
 
J Arthroplasty. 2018 Jun;33(6):1757-1763.e1., American Joint Replacement Registry 2019 Annual Report.  
 
第四代的陶瓷股骨頭已經夠強夠安全,而陶瓷襯墊則受限於幾何形狀、機械性質、固定機制,仍未能突破。
“The latest generation of ceramic has greatly reduced the odds of head fracture but not of liner fracture.”  
Bone Joint J. 2017 Aug;99-B(8):1012-1019.  
Squeaking in the fourth-generation ceramic bearing occurred at a rate of 3%.”
J Orthop Surg Res. 2018 Jun 1;13(1):133.


 
陶瓷襯墊碎裂,與撞擊、植入物設計、外傷、體重等原因有關。
“The major cause of liner fracture is neck-cup impingement, followed by other factors like prosthesis design, traumas and patient weight.”  
Acta Biomed. 2019 Dec 5;90(12-S):192-195.  
 
陶瓷襯墊擺位不正的風險因子則有年齡、術前屈曲角度較低、OA、骨硬化。
“Age, preoperative less flextion, osteoarthritis, and the bone sclerotic were independent risk factors determining malseating of ceramic liners”  
Orthop Traumatol Surg Res. 2019 May;105(3):453-459.  

目前已有證據等級Level 1的隨機對照試驗(Randomized Controlled Trial)加上最高精確度的放射立體照相測量分析(Radiostereometric Analysis),可以說明維他命E襯墊在臨床使用的優異表現:
 
維他命E襯墊在體內的中期磨損量,已經低至無法測得的程度,且與Highly Crosslinked襯墊相比有顯著差異。
“The five-year median (interquartile range) proximal femoral head penetration into the E1 was -0.05 mm (-0.13 to -0.02).”  
Bone Joint J. 2017 May;99-B(5):577-584.
“Mean 7 year linear proximal penetration was -0.07mm (SD 0.16) for VEPE.”  
Bone Joint J. 2019 Jul;101-B(7):760-767.  
 
磨耗測試顯示,維他命E襯墊使用100百萬次(大約為一般人100年的活動量)的磨損量,僅僅等同於傳統襯墊的5百萬次(使用5年)。
100 Mc testing of VE-HXPE produced equivalent total volume (~ 200mg) of wear as 5 Mc of in-vitro testing of CPE.”  
Mimnaugh et al, ORS 2016 Annual Meeting Paper No. 0403.  


 
加速老化極限測試中,當其他襯墊全部都氧化衰退後,維他命E襯墊依然可保持在最佳狀態。
“Extreme accelerated aging conditions: 70°C, 5 atm, 100% oxygen; NO oxidation of Vit-E HXPE was found.”  
Peiserich et al, ORS 2013, Poster #1060., Pletcher D et al. ORS 2014, Poster #1868.

 
維他命E襯墊的韌度絕佳,在經過2百萬次的邊緣撞擊測試之後,仍然正常無損。
No cracks or other gross damage under 2 Million cycles of rim impingement loading.
Data on File at Zimmer Biomet  


最後,能否使用大頭的真正關鍵在於「襯墊」,透過特殊製程將耐用度及強韌度大幅提升後,便能安全地將厚度降下來,放大Head所需空間。目前維他命E襯墊的技術,已經可以做到在50mm髖臼杯用上36mm大頭(54mm則能用到40mm大頭),綜合以上各方面,可說是現今最理想的選擇。 



 

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