
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。
