Abstract
Background: Poly (methyl methacrylate) (PMMA) bone cement is widely used to anchor total joint replacements to the contiguous bone. Among the clinically-relevant properties of this material is its intrusion depth (ID) because it indicates the potential for interdigitation of the curing cement into the interstices of the cancellous bone. ID is determined using procedures stipulated in ISO 5833. There is only one study in which ISO 5833 was examined critically, but only one exogenous variable was considered.
Purpose: We carried out an extensive critical analysis of the ISO 5833 Standard with a view to making recommendations for revising it. Materials and Methods: 7 approved PMMA bone cement brands (covering low-, medium-, and high-viscosity brands) were used in two series of tests. In the first series, the influence of time at which ID was determined (relative to achievement of cement doughing time (DT)) was delineated. In the second series, the influence of three clinically-relevant variables on ID for each of these brands was determined and, then, response surface methodology was used to analyze the results. Results: ID results are given for both series of tests. Over the range of the variables used, the optimum IDs for a low-, medium-, and high-viscosity brand were computed to be 5.7 mm, 3.1 mm, and 2.4 mm, respectively. Conclusion: The findings allowed us to recommend that the following revisions be made to stipulations in ISO 5833 for determining ID: prior to running the ID test, store the cement unit at 1°C; 60 minutes after removing the cement unit from the storage medium, mix the cement powder and liquid, in a vacuum chamber, at 120 rpm; and determine ID 3 minutes after DT is achieved.Keywords: Doughing time, ISO 5833 standard, orthopaedics, PMMA BONE CEMENT, poly (methyl methacrylate) (PMMA), response surface methodology.
Graphical Abstract
[2]
National joint registry for England Wales, Northern Ireland, and Isle of Man 15th annual report-2018. London, UK: NJR 2018.
[3]
Robertsson O, Lindgren L, Sundberg M. W-Dahl A The Swedish knee arthroplasty register-annual report 2018. Lund, Sweden: Lund University 2018.
[4]
Kuhn K-D, Ed. Management of periprosthetic joint infection. Berlin, Germany: Springer Verlag GmbH 2018.
[http://dx.doi.org/10.1007/978-3-662-54469-3]
[http://dx.doi.org/10.1007/978-3-662-54469-3]
[5]
Lewis G. Properties of acrylic bone cement: State of the art review. J Biomed Mater Res 1997; 38(2): 155-82.
[http://dx.doi.org/10.1002/(SICI)1097-4636(199722)38:2<155:AID-JBM10>3.0.CO;2-C] [PMID: 9178743]
[http://dx.doi.org/10.1002/(SICI)1097-4636(199722)38:2<155:AID-JBM10>3.0.CO;2-C] [PMID: 9178743]
[6]
Ling RSM. Prevention of loosening of hip components In: Riley EH, Ed. Proceedings of the eighth open scientific meeting of the Hip Society. Norway Mosby 1981; pp. 292-307.
[7]
Cristofolini L, Baleani M. Testing the mechanical properties of polymethylmethacrylate bone cement; A critical analysis of the ISO 5833 standard. Oste Ing und Arch Zeit (OIAZ) 1999. 144 Jg Heft 5
[8]
American society for testing and materials (ASTM) ASTM F451: Standard specification for acrylic bone cement. West Conshohocken, PA, USA: ASTM international 2019.
[9]
International standards organization (ISO).. ISO 5833: Implants for surgery-Acrylic resin cements. Geneva, Switzerland: ISO 2012.
[10]
Myers RH, Montgomery DC, Anderson-Cook CM. Response Surface methodology: Process and product optimization. 4th ed. New York, NY, USA: John Wiley & Sons 2016.
[11]
Kuhn K-D. Bone cements. Berlin: Springer-Verlag GmbH 2000.
[http://dx.doi.org/10.1007/978-3-642-59762-6]
[http://dx.doi.org/10.1007/978-3-642-59762-6]
[12]
Mau H, Schelling K, Heisel C, Wang J-S, Breusch SJ. Comparison of various vacuum mixing systems and bone cements as regards reliability, porosity and bending strength. Acta Orthop Scand 2004; 75(2): 160-72.
[http://dx.doi.org/10.1080/00016470412331294415] [PMID: 15180231]
[http://dx.doi.org/10.1080/00016470412331294415] [PMID: 15180231]
[13]
Koh BTH, Tan JH, Ramruttun AK, Wang W. Effect of storage temperature and equilibration time on polymethyl methacrylate (PMMA) bone cement polymerization in joint replacement surgery. J Orthop Surg Res 2015; 10: 178.
[14]
Pithankuakul K, Samranvedhya W, Visutipol B, Rojviroj S. The effects of different mixing speeds on the elution and strength of high-dose antibiotic-loaded bone cement created with the hand-mixed technique. J Arthroplasty 2015; 30(5): 858-63.
[http://dx.doi.org/10.1016/j.arth.2014.12.003] [PMID: 25522957]
[http://dx.doi.org/10.1016/j.arth.2014.12.003] [PMID: 25522957]
Article Metrics
1
1