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High Early Strength Calcium Phosphate Bone Cement: Effects of Dicalcium Phosphate Dihydrate and Absorbable Fibers

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High Early Strength Calcium Phosphate Bone Cement: Effects of Dicalcium Phosphate Dihydrate and Absorbable Fibers High early strength calcium phosphate bone cement: Effects of dicalcium phosphate dihydrate and absorbable fibers Elena F. Burguera,1 Hockin H. K. Xu,2 Shozo Takagi,2 Laurence C. Chow2 1Instituto de Cera´mica de Galicia, Universidad de Santiago de Compostela, 15782 Santiago de Compostela, Spain 2Paffenbarger Research Center, American Dental Association Foundation, National Institute of Standards and Technology, Gaithersburg, Maryland 20899 Received 15 November 2004; revised 8 June 2005; accepted 9 June 2005 Published online 25 August 2005 in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/jbm.a.30497 Abstract: Calcium phosphate cement (CPC) sets in situ to tals in the cements. At 30 min, the flexural strength (mean Ϯ ϭ form resorbable hydroxyapatite with chemical and crystal- standard deviation; n 5) was 0 MPa for CPCA (the paste Ϯ Ϯ lographic similarity to the apatite in human bones, hence it did not set), (4.2 0.3) MPa for CPCD, and (10.7 2.4) MPa is highly promising for clinical applications. The objective of for CPCD-fiber specimens, significantly different from each the present study was to develop a CPC that is fast setting other (Tukey’s at 0.95). The work of fracture (toughness) was and has high strength in the early stages of implantation. increased by two orders of magnitude for the CPCD-fiber Two approaches were combined to impart high early cement. The high early strength matched the reported strength to the cement: the use of dicalcium phosphate di- strength for cancellous bone and sintered porous hydroxy- hydrate with a high solubility (which formed the cement apatite implants. The composite strength Sc was correlated ϭ CPCD) instead of anhydrous dicalcium phosphate (which to the matrix strength Sm: Sc 2.16Sm. In summary, sub- formed the conventional cement CPCA), and the incorpora- stantial early strength was imparted to a moldable, self- tion of absorbable fibers. A 2 ϫ 8 design was tested with two hardening and resorbable hydroxyapatite via two synergis- materials (CPCA and CPCD) and eight levels of cement tic approaches: dicalcium phosphate dihydrate, and reaction time: 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 8 h, and absorbable fibers. The new fast-setting and strong cement 24 h. An absorbable suture fiber was incorporated into ce- may help prevent catastrophic fracture or disintegration in ments at 25% volume fraction. The Gilmore needle method moderate stress-bearing bone repairs. © 2005 Wiley Period- measured a hardening time of 15.8 min for CPCD, five-fold icals, Inc. J Biomed Mater Res 75A: 966–975, 2005 faster than 81.5 min for CPCA, at a powder:liquid ratio of 3:1. Scanning electron microscopy revealed the formation of Key words: calcium phosphate cement; hydroxyapatite; nanosized rod-like hydroxyapatite crystals and platelet crys- early strength; fast setting; absorbable fibers; bone repair INTRODUCTION in 1986.1 Since then, many compositions of calcium phosphate cements have been formulated and test- 2–6 Calcium phosphate cements can be molded and ed. CPC is comprised of a mixture of fine particles self-harden in the prepared bone site to form resorb- of tetracalcium phosphate [TTCP: Ca4(PO4)2O] and 1 1 able hydroxyapatite. The first self-setting calcium dicalcium phosphate anhydrous [DCPA: CaHPO4]. phosphate cement, referred to as CPC, was developed Because the hydroxyapatite from CPC is formed in an aqueous environment at body temperature, it is more Certain commercial materials and equipment are identi- similar to biological apatites than sintered hydroxyap- fied in this article to specify experimental procedures. In no atite formed at high temperatures.7–11 Due to its self- instance does such identification imply recommendation by setting ability, excellent osteoconductivity, and bone NIST or the ADA Foundation, or that the material identified replacement capability, CPC is highly promising for a is necessarily the best available for the purpose. 7–11 Correspondence to: H. Xu; e-mail: [email protected] wide range of clinical applications. Contract grant sponsor: USPHS; contract grant numbers: However, the low strength of CPC has limited its R29 DE12476, R01 DE14190, R01 DE11789 use to only nonstress applications,8 and clinical usage Contract grant sponsor: NIST has been severely hindered by its brittleness.10 One Contract grant sponsor: ADAF Contract grant sponsor: Great-West Life Annuity clinical study on the repair of periodontal bone defects demonstrated that the brittle nature of CPC caused © 2005 Wiley Periodicals, Inc. early exfoliation of all or pieces of the implant.12 An- CALCIUM PHOSPHATE BONE CEMENT 967 other major shortcoming is that it takes a relatively particles with sizes ranging from 0.4 ␮mto6␮m, with a long time for the CPC paste to set. A long setting time median particle size of 1.2 ␮m. The TTCP and DCPA pow- can result in the crumbling of CPC when the paste ders were then mixed in a micromill (Bel-Alert Products, comes in contact with physiological fluids, or if bleed- Pequannock, NJ) in equimolar amounts to form the powder for the cement designated as CPC . ing occurs due to the difficulty in some cases to A Preliminary studies using commercial dicalcium phos- achieve complete hemostasis.4,13,14 Low strength in phate dihydrate (DCPD) powders yielded long setting times the early postoperative stage (low early strength) can of greater than 1 h for the TTCP-DCPD paste, likely due to result in the cement to fail or disintegrate under even certain unidentified impurities in the commercial pow- moderate stresses. Studies were carried out to over- ders.18 Therefore, the DCPD powder used in the present 14–17 come these disadvantages of CPC. Hydroxypro- study was prepared in the laboratory. The pH was slowly pyl methylcellulose and other gelling agents were in- raised via the addition of CaCO3 for a DCPD–monocalcium corporated into CPC to render the paste more phosphate monohydrate singular point solution at a pH of cohesive and resistant to washout.14,15 Chitosan, a 1.9 and a temperature of 4°C. DCPD that precipitated before biopolymer, imparted nonrigidity, high toughness, the pH reached about 3.5, which is significantly below the and fast-setting to CPC.16,17 In a more recent study,18 hydroxyapatite-DCPD singular point of 4.2, was collected to dicalcium phosphate dihydrate (DCPD, CaHPO avoid possible contamination of the DCPD by hydroxyapa- 4 tite. The DCPD was washed, first with distilled water, and ⅐ 2H O), a calcium phosphate compound known to 2 then with ethanol of 95%, and then dried in air. The DCPD possess a relatively high solubility and resorbabil- 19,20 was ground in water with a ball mill to obtain particles with ity, was used to replace the DCPA component in size ranging from approximately 0.5 to 4 ␮m and a median CPC. The high solubility of DCPD resulted in the fast particle size of 1.3 ␮m. The DCPD powder was mixed with setting of the cement, yielding a hardening time of the TTCP powder at a molar ratio of 1:1 to form the powder about 15 min with water used as the cement liquid for the cement referred to as CPCD. and 6 min with the use of a phosphate solution, al- though the phosphate solution resulted in a lower cement strength.18 Measurement of cement setting time The objective of the present study was to develop a hydroxyapatite cement that can quickly develop high strength shortly after paste placement. Two ap- The CPC powder and liquid were manually mixed with a spatula to form a paste that was filled into a stainless steel proaches were tested: the use of DCPD in the place of 21 mold of 6-mm diameter and 3-mm depth. Distilled water DCPA to form the cement, and the incorporation of was used as the cement liquid. Each specimen in the mold absorbable fibers. The fibers would provide the was sandwiched between two glass slides, and the assembly needed early strength and then be dissolved to create was incubated in a humidor with 100% relative humidity at long cylindrical macropores for cell infiltration and 37°C. The hardening time was measured using the Gilmore bone ingrowth. It was hypothesized that combining needle method with a load of 453.5 g and a flat tip diameter the two approaches synergistically would substan- of 1.06 mm.22 A cement specimen was considered set when tially increase the early strength, elastic modulus, and the needle loaded onto the specimen surface failed to leave work of fracture (toughness) for the cement compared a perceptible indentation. The time measured from the paste ϫ to using a single approach. It was further hypothe- being mixed to this point was used as the setting time. A 2 5 full-factorial design was tested with two materials (CPC sized that these properties would significantly depend A and CPC ) and five powder:liquid mass ratios (4.5:1, 4:1, on the cement reaction time (or incubation time). D 3.5:1, 3:1, and 2.5:1). Fabrication of CPC MATERIALS AND METHODS A and CPCD specimens To investigate the early strength of CPC and its depen- Preparation of CPCA and CPCD dence on cement incubation time, a 2 ϫ 8 full-factorial design was tested with two materials (CPCA and CPCD) and The tetracalcium phosphate (TTCP) powder was synthe- eight levels of incubation time: 15 min, 30 min, 1 h, 1.5 h, 2 h, sized from a solid-state reaction between CaHPO4 (dical- 4 h, 8 h, and 24 h. The incubation time was defined as the cium phosphate anhydrous, DCPA) and CaCO3 (Baker An- time from the paste being mixed to the specimen being alyzed Reagents, J.
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