X3
Præcist konstrueret polyethylen
Vores X3-polyethylen understøtter vores løsninger inden for total hofte-, knæ- og skulderartroplastik. Den patenterede X3-fremstillingsproces med sekventiel tværbinding benytter tre separate gammastrålingsdoser med et hybridiseringstrin efter hver.
Meget tværbundet polyethylen
X3 har en patenteret1 strålingsproces på tre trin med gammastråling på 3 megarad (i alt 9 megarad) og hybridisering.2 Denne særlige udvikling af X3 sørger for slidstyrke,3,4 mekanisk styrke5 og resistens over for oxydering6 uden brug af tilsætningsstoffer. Strykers strålings- og hybridiseringsproces for X3 har ikke ændret sig siden dets udvikling, hvilket gør det muligt at bevare de grundlæggende og positive funktionelle egenskaber ved X3. Siden X3 først blev anvendt i ortopædien er der foretaget over 5 mio. implantationer på verdensplan på tværs af hofte- og knæalloplastik.7 Den signifikante mængde af kliniske data og ledregistreringsdata om X3 understøtter dets anvendelse i TKA8-11 og THA.12-17
Overfladedesign af X3-polyethylenleje og kliniske resultater
X3-VA-2_22221
Før 2018 omfattede alle publicerede X3-data produktfremstilling ved hjælp af konsolideret kompressionsstøbning og gasplasmasterilisering. I 2018 tilføjede Stryker konsolideret stempelekstrudering og EtO-steriliseringsfunktioner til X3-fremstillingsprocessen.
Referencer:
- Wang A, Dumbleton JH, Essner A, Yau S, inventors; Howmedica Osteonics Corp, assignee. Sequentially cross-linked polyethylene. US patent 7,517,919. April 14, 2009.
- Wang A, Zeng H, Yau S-S, Essner A, Manely M, Dumbleton J. Wear, oxidation and mechanical properties of a sequentially irradiated and annealed UHMWPE in total joint replacement. J Phys D Appl Phys. 2006;39(15):3213-3219. doi:10.1088/0022-3727/39/15/S12
- Bonutti P, Essner A, Herrera L, Longaray J, Kester M. Influence of design and bearing materials on wear: comparing two different TKA designs. Poster presented at: 25th Annual Congress of the International Society for Technology in Arthroplasty; October 3-6, 2012; Sydney, Australia.
- Stryker Test Report RD-13-109. Wear evaluation of a hindered-phenol polyethylene compared to X3 polyethylene. 2013.
- Yau S-S Essner A, Manley MT, Dumbleton JH. Sequential irradiation and annealing of highly crosslinked polyethylenes: resist oxidation without sacrificing physical/ mechanical properties. Poster presented at: 51st Annual Meeting of the Orthopaedic Research Society; February 20-23, 2005; Washington, D.C.
- Yau S-S, Le K-P, Blitz JW, Dumbleton JH. Real-time shelf aging of sequential crosslinked and annealed UHMWPE. Poster presented at: 55th Annual Meeting of the Orthopaedic Research Society; February 22-25, 2009; Las Vegas, NV.
- Sales data on file at Stryker.
- National Joint Replacement Registry. Hip, Knee & Shoulder Arthroplasty Annual Report 2017. Australian Orthopaedic Association; 2017.
- Meneghini RM, Ireland PH, Bhowmik-Stoker M. Multicenter study of highly cross-linked vs conventional polyethylene in total knee arthroplasty. J Arthroplasty. 2016;31(4):809-814. doi:10.1016/j.arth.2015.10.034
- Harwin SF, Issa K, Given K, et al. Clinical and patient-reported outcomes of primary TKA with a single-radius design. Orthopedics. 2013;36(7):e877-e882. doi:10.3928/01477447-20130624-17
- National Joint Registry for England, Wales and Northern Ireland and Isle of Man. 14th Annual Report. 2017.
- Campbell D, Callary S, Field J. Wear of a second-generation XLPE liner remains low at 10 years: an RSA study. Abstract presented at: 2017 ANZORS-RSA Joint Conference; October 6-8, 2017; Adelaide, SA, Australia.
- Gaudiana MA, White PB, Ghazi N, Ranawat AS, Ranawat CS. Wear rates with large metal and ceramic heads on a second generation highly cross-linked polyethylene at mean 6-year follow-up. J Arthroplasty. 33(2):590-594. doi:10.1016/j.arth.2017.09.006
- Epinette JA, Harwin SF, Rowan FE, et al. Early experience with dual mobility acetabular systems featuring highly cross-linked polyethylene liners for primary hip arthroplasty in patients under fifty five years of age: an international multi-centre preliminary study. Int Orthop. 2017;41(3):543-550. doi:10.1007/s00264-016-3367-0
- D’Antonio JA, Capello WN, Mesko JW, Ramakrishnan R. Second-generation annealed highly crosslinked polyethylene has low wear at mean seven year follow-up. Surg Technol Int. 2014;25:219-226.
- Takada R, Jinno T, Koga D, Miyatake K, Muneta T, Okawa A. Comparison of wear rate and osteolysis between second-generation annealed and first-generation remelted highly cross-linked polyethylene in total hip arthroplasty. A case control study at a minimum of five years. Orthop Traumatol Surg Res. 103(4):537-541. doi:10.1016/j.otsr.2017.02.004
- Epinette JA, Jolles-Haeberli BM. Comparative results from a national joint registry hip data set of a new cross-linked annealed polyethylene vs both conventional polyethylene and ceramic bearings. J Arthroplasty. 31(7):1483-1491. doi:10.1016/j.arth.2015.12.041
X3-WC-4_28621