The Journal of Arthroplasty Vol. 19 No.

5 2004

Cement Microcracks in Thin-Mantle Regions After In Vitro Fatigue Loading

Kenneth A. Mann, PhD,* Sameer Gupta, BS,* Amos Race, PhD,* Mark A. Miller, MS,* Richard J. Cleary, PhD, and David C. Ayers, MD*

Abstract: An in vitro study of cemented femoral hip components was conducted to determine if microcracks in the cement mantle would preferentially form in thinmantle regions as a result of cyclic fatigue loading via stair-climbing. Overall, there was not an increased amount of microcracks in thin-mantle (2 mm) regions (number found/number expected 0.59, P.03). However, through cracks that extended between the stem to the bone were more prevalent in thin-mantle regions (number found/number expected 2.93, P.03). Although cracks form throughout the cement mantle and appear to grow at the same rate, thin-mantle regions are most likely to have through cracks after fatigue loading. This is consistent with results from at-autopsy studies of well-xed femoral components and supports the general guideline that thin-mantle regions should be avoided in the cementing of the femoral stem. Key words: cement, fatigue, biomechanical, cracks, loosening. 2004 Elsevier Inc. All rights reserved.

Thin cement mantles are thought to be associated with increased risk of aseptic loosening of the femoral component of cemented total hip arthroplasties [13]. Areas of thin mantles also have been associated with regions of osteolysis [4]. This suggests that fracture of the cement between the stem and bone may allow debris to elicit an osteolytic response.

From the *Department of Orthopedic Surgery, Upstate Medical University, Syracuse, New York; and the Department of Mathematical Sciences, Bentley College, Waltham, Massachusetts. Submitted December 31, 2002; accepted December 15, 2003. Benets or funds were received in partial or total support of the research material described in this article from the National Institutes of Health (NIH AR42017). Femoral stems were provided by J&J-DePuy, Inc., Warsaw, Indiana; and Simplex cement was donated by Stryker-Howmedica-Osteonics, Mahwah, New Jersey. Reprint requests: Kenneth A. Mann, PhD, 3216 Institute for Human Performance, Upstate Medical University, 750 East Adams Street, Syracuse, NY 13210. 2004 Elsevier Inc. All rights reserved. 0883-5403/04/1905-0012$30.00/0 doi:10.1016/j.arth.2003.12.080

At-autopsy retrieval studies of well-functioning femoral constructs support the concept that cracks are more likely to occur in thin-mantle regions. In a retrieval study of 8 hips, Kawate et al. [5] found most (92 of 101) cracks in thin-mantle regions of 1 mm thick. Similarly, Kadakia [6] reported that in 11 hips, 96% of complete wall fractures were found in cement mantles that were 2 mm thick. The cracks appeared to be open, with a gap between the crack surfaces. This could allow direct communication of uid between the stem and bone. How these cracks develop as a result of loading remains unclear. In vitro studies of idealized stemcement-bone constructs have shown that some microcracks exist at the time of implantation and that these grow in length and number with cyclic loading [7]. There is also some evidence that thinmantle regions incur higher stresses upon loading and thus would be expected to have cracks grow more quickly [8,9]. However, the experimental and computational models are relatively simplistic and do not directly address the entire cemented stem construct.

605

606 The Journal of Arthroplasty Vol. 19 No. 5 August 2004 Recently, a cadaver-based model was developed in which aggressive stair-climbing loading could be applied, followed by sectioning and detailed analysis of microcrack distribution in the cement [10]. In that study, more cracks were found to be associated with the trabecular bone than the stem-cement interface or voids in the cement. In the present companion study, we wanted to determine if the distributions of cracks were related to mantle thickness such as were found in clinical and retrieval studies. Specically, we hypothesized that there would be more cracks in thin-mantle regions and that cracks would grow more quickly in thin-mantle regions after fatigue loading. the large long-axis torque component that has been associated with high cement-mantle stresses [11]. Transverse sections of the constructs were made using a water-irrigated, high-speed saw with a silicon-carbide blade (Buehler, Inc, Lake Bluff, IL) at 10-mm intervals starting at the collar. A total of 11 sections were made from collar to tip, but 2 sections were discarded at the mid-stem level because of the presence of a portal for a micromotion measuring device used in the companion study [10]. Specimens were stained with a uorescent dye penetrant (Aquacheck, Sherwin Inc., South Gate, CA), and images were captured with a digital camera attached to an epiuorescent microscope with a pixel resolution of 0.0148 mm per pixel. Three contours were collected digitally for each section: the stem, broach line, and extent of cement into the bone (Fig. 1). The broach line here represents the cavity of bone left in the femur after broaching was complete. The region of the mantle that extended from the stem to the broach line was dened as the broached zone. The region of the mantle that extended from the broach line to the extent of cement was dened as the interdigitated zone. This region contained trabecular bone that was interdigitated with cement. Microcracks found in each section were documented by crack length and by x-y coordinates of the crack. Each crack was further assigned a crack type as follows. Cracks that existed in the broached or interdigitated zone were dened as broach or interdigitated cracks, respectively. Broach cracks were subdivided further as cracks that were either through cracks or notthrough cracks. Through cracks ended at the stem and bone surface. Not-through cracks either could extend from the stem into the mantle, from the bone into the mantle, from voids in the mantle, or as discrete mantle cracks that did not extend to any feature in the construct. A computer program was developed to determine the mantle thickness associated with each crack and the overall distribution of mantle thickness for each bone. The thickness of the mantle associated with the cracks (c-thickness) was calculated as the distance from the stem to the cement line using a perpendicular line construction that passed from the stem surface through the centroid of each crack. The thickness was further divided into broach (cb) and interdigitated (ci) thickness. To provide a measure of the overall distribution of mantle thickness for each bone, mantle thickness (m-thickness) was calculated by dividing the stem contours into 1-mm increments for all sections. A perpendicular line was constructed from each stem point to determine the broach (mb) and interdigitated (mi) thickness.

Materials and Methods

A total of 8 fresh-frozen human femurs were thawed before use. Femora were radiographed and templated to ensure appropriate stem size (Flanged 45 Cobra, DePuy Orthopaedics, Leeds, England). Contemporary cementing techniques were used, including broaching, brush lavage, insertion of a distal plug, and retrograde ll with a cement gun. The polymethylmethacrylate (PMMA) cement (Simplex, Stryker-Howmedica-Osteonics, Mahwah, NJ) was vacuum-mixed before insertion and was applied in a doughy state at about 4 minutes after the start of mixing at 23C. Cement insertion time was determined using the does not stick to glove criterion. Pressurization was applied using a proximal restrictor, followed by further cement application with the cement gun. A distal centralizer was not used with this stem design. Six of the femurs were designated for mechanical fatigue loading, and 2 specimens were retained as unloaded controls. Before loading, the cemented femurs were soaked in a saline bath for 24 hours. They were potted distally and placed in a stairclimbing apparatus that applied a femoral head load and abductor load. Moist gauze was applied to the femoral cortex to maintain hydration during testing. Mechanical testing consisted of loading for 300,000 cycles at 2 Hz using 80% of the peak load for the rst half of the experiment and 100% of the peak load for the second half. The applied head load (1,040 to 1,780N) was determined by a scaling process and was based on the initial construct stiffness [10]. This scaling process allowed us to apply loads proportional to the stiffness of the structure and reduced the risk of premature failure of the bones during fatigue loading. Stair-climbing loading was used as an aggressive loading regimen given

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Fig. 1. Reected-light image of transverse cross-section illustrating broach and interdigitated zones (left). Examples of interdigitated, notthrough and through crack types are shown after staining with uoresecent dye and imaged with epiuorescent light (right). Stem (S), cement (C), and bone (B) are indicated on the images.

Collection of data for all points from all sections provided an overall measure of mantle thickness distribution. An average of 349 m-thickness measurements were made for each bone (range, 327 358). The distribution of crack counts was determined for each bone as a function of c-thickness. Crack counts were binned over 2-mm increments from 0 to 10 mm. A nal bin contained mantle thicknesses between 10 and 15 mm. The thickness measure used depended on the type of crack so that cracks in the broached zone were compared by broached zone thickness and cracks in the interdigitated zone were compared by interdigitated thickness. To compare the distribution of cracks (c-thickness) to the distribution of m-thickness in each construct, a ratio scale was developed. The ratio of number of cracks found in each bone to the number of cracks expected based on m-thickness distribution was determined for each bin range. Mathematically, this can be written as:

b f/e ratioa

b # cracksa b # mantlea 15 15 # cracks0 # mantle0

b where f/e ratioa is the found/expected ratio over the b range of thickness from a to b, # cracksa and b # mantlea are the number of cracks and mantle distributions over the same range, respectively. The entire range of mantle thickness measurements spanned 0 to 15 mm. F/e ratios 1.0 indicate more cracks than would be expected based on a hypothetical even distribution of cracks over the entire cement mantle. To test the hypothesis that cracks were more prevalent in thin-mantle regions, a nonparametric Wilcoxon signed rank test was used between the number of cracks found and the number of cracks expected based on the m-thickness distribution [12]. This was performed on a bone-by-bone basis so that 6 pairs (found-expected) of data were analyzed for the loaded case. Statistical analysis was

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Table 1. Descriptive Statistical Data for Mantle Thickness Associated With Cracks in the 6 Loaded and 2 Nonloaded Cemented Femoral Constructs
Crack Count (N), Mean (SD) Loaded All cracks Interdigitated zone Broach zone Not-through Through 398 (122) 181 (70) 217 (62) 198 (60) 19 (10) Nonloaded 222 (8) 137 (23) 84 (16) 71 (11) 12 (5) Mantle Thickness (c-thickness, mm), Mean (SD) Loaded 5.9 (1.1) 3.2 (2.8) 2.8 (1.7) 3.0 (1.7) 0.9 (0.6) Nonloaded 4.8 (1.1) 1.2 (0.6) 2.5 (1.1) 2.7 (1.2) 0.8 (0.2) Thin-mantle Region, (c 2 mm, %) Loaded 8.9 (4.3) 43.3 (20.0) 39.0 (12.8) 33.8 (11.8) 92.5 (16.9) Nonloaded 15.1 (0.8) 75.6 (21.6) 60.9 (24.1) 55.3 (27.4) 96.9 (4.4)

not performed on the unloaded specimens because of limited sample size. For all cases, thin mantles were dened as regions 2 mm thick. A Wilcoxon signed rank test was chosen over a test with ratios because small data samples in the denominator (expected count) could skew data calculations. Statistical tests were performed for interdigitated cracks in the interdigitated zone and both through and not-through cracks in the broach zone. The length of cracks as a function of mantle thickness also was cataloged for each mantle/crack category. An analysis of covariance (ANCOVA) was used to test the hypothesis that cracks would grow more quickly in thin-mantle regions upon loading.

Results
There was an average of 398 microcracks found in the loaded cemented constructs (range, 195 576) and 222 cracks in the nonloaded constructs (range, 216 227). The cracks were generally of short length, with cracks from loaded specimens (0.49 0.37 mm) being longer (P.001) than those from nonloaded specimens (0.25 0.17 mm). In terms of crack count, about half of the cracks were from interdigitated cement-bone regions (Table 1). Of those cracks that were present in the broach region, the vast majority were notthrough cracks. Overall, the mantle thickness associated with each of the cracks (c-thickness) was distributed over a broad range, with an average thickness of 5.9 mm (Fig. 2). Less than 10% of cracks in the loaded specimens (Table 1) were from thin-mantle regions (c 2 mm). Separating the cracks into regions, we found that about 43% of the cracks in the interdigitated zone were from thin-mantle regions (ci 2mm). For the broached region, 34% of the notthrough cracks were from thin-mantle regions

(cb 2 mm), whereas 92% of the through cracks were from thin-mantle regions (cb 2 mm). The distribution of m-thickness (Table 2) showed that 17.6% of the mantles were thin (m 2 mm). This is similar to the mantle-thickness study performed by Valdivia et al. [13], in which they found that, using a variety of stem designs, between 9% and 28% of the mantle regions were thin. The overall, interdigitated, and broached zone mantle thicknesses were, on average, 4.8 mm, 1.8 mm, and 3.1 mm thick, respectively. Overall, there were signicantly fewer microcracks in thin-mantle (2 mm) regions (f/e ratio 0.59, P.03) than would be expected based on an even distribution of cracks over the cement mantle. When this was broken down into interdigitated and broach zones, we found 2 different trends (Fig. 3). For the interdigitated zone, more cracks were found where the interdigitated thickness was greater. The opposite trend was found with the broach zone; fewer cracks were found in thicker broach-thickness regions. Through cracks in thin-mantle regions had an f/e ratio of 2.9 (P.03); there were about 3 times as many through cracks located in thin-mantle (broachlength) regions than would be expected based on the overall distribution of mantle thicknesses. The nonloaded specimens showed trends that were qualitatively similar to the loaded specimens in terms of distribution of cracks. In the broached zone, nonloaded cracks were 0.30 mm (SD 0.23 mm) in length but were signicantly shorter (P.0001) than cracks in the loaded specimens (0.58 0.45 mm). Crack length did not depend on mantle thickness (P.48) in either the loaded or nonloaded specimens (Fig. 4). However, it is clear that cracks in thinner-mantle regions were closer to approaching a theoretical through-crack condition.

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Fig. 2. Average crack counts as a function of mantle thickness for both loaded and nonloaded specimens. Standard-deviation bars are included for the 6 loaded specimens.

Discussion
The overall goal of this work was to determine if cracks in the cement mantle would preferentially form and grow in thin-mantle regions under an aggressive stair-climbing loading regimen. Using an

Table 2. Overall Frequency Distribution of Mantle Thickness (m-Thickness) Using 1-mm Increments Around the Stem
Thickness Range (mm) 0 to 2 2 to 4 4 to 6 6 to 8 8 to 10 10 to 15 Mantle Thickness (m), % 17.6 (9.5) 30.4 (9.3) 22.8 (6.4) 16.0 (6.8) 8.8 (5.2) 4.5 (3.7) Interdigitated Thickness (mi), % 71.0 (12.6) 19.0 (7.5) 5.7 (4.3) 2.4 (2.8) 1.3 (1.5) 0.6 (0.8) Broach Thickness (mb), % 35.9 (16.3) 36.3 (6.9) 19.1 (11.0) 6.1 (6.2) 2.3 (4.2) 0.3 (0.6)

NOTE. An average of 349 mantle data points were collected per bone.

in vitro model, we found that, overall, there were not an increased number of microcracks in thinmantle regions. However, through cracks were more prevalent in thin-mantle regions. Furthermore, cracks that existed after cement cure did not grow faster in thin-mantle regions after fatigue loading. The major shortcoming of the present in vitro study is the limited loading regimen and the lack of biological changes to the bone that would occur in vivo. The loading in this study was limited to 300,000 stair-climbing cycles, with no changes in loading pattern or rest during loading. Although this loading was aggressive in terms of stress application, the number of loading cycles is only a small fraction of what would be experienced over the life of the implant system [14]. Preliminary studies conducted in our laboratory with the stair-climbing loading regimen showed that fatigue failure of the cortical bone can occur using loading cycles in the 300,000 to 1 million range. Therefore, for the current system without bone remodeling, we are ap-

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Fig. 3. Ratio of f/e crack counts as a function of mantle thickness for both loaded and nonloaded specimens. Standard-deviation bars are included for the 6 loaded specimens.

proaching the fatigue limit of the femoral system. Bone adaptation would certainly be expected to affect the load transfer within the cement mantle. However, at least for well-functioning joint replacements, the interdigitation between the cement and bone may remain intact for many years [15]. The results for through cracks in this study are consistent with at-autopsy retrievals of well-xed femoral components in terms of distribution of through cracks. Kawate et al. [5] found 92 of 101 cement cracks in areas where the mantles were 1 mm thick. In a different retrieval study of 11 hips, Kadakia et al. [6] found that 96% of complete wall fractures were found in cement mantles that were 2 mm thick. In these 2 studies, cracks were identied under white-light conditions and the cracks appeared to be open, ie, there were gaps between the crack faces. These macrocracks are in contrast to the microcracks found in the present study. The microcracks found in this study are not evident under standard white-reected light conditions, be-

cause the crack surfaces are, in general, closed. However, microcracks can be clearly observed under epiuorescent lighting conditions after application of a uorescent dye penetrant that is absorbed into these cracks. Thus, we can assume that additional microcracks that were not identied existed in the at-autopsy specimens. One could also speculate that the microcracks found in this study would grow into macrocracks with additional loading. Comparing loaded with nonloaded specimens supports this; cracks grow longer and become more frequent after fatigue loading. Broach thickness was used as the mantle-thickness measure for through cracks in this study. This is in contrast to retrieval studies in which mantle thickness was dened as the total thickness from stem to extent of cement in the bone. Broach thickness was chosen over the full mantle thickness because cracks that developed between the stem and bone would have the potential for debris transport, irrespective of total mantle thickness. How-

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Fig. 4. Crack-length distribution as a function of broach thickness for loaded and nonloaded specimens. The straight line labeled as Through Crack represents points at which the broach thickness equals the crack length; one would not expect crack length to be substantially longer than broach thickness because of geometric considerations.

ever, total mantle thickness often was very similar to broach thickness. Performing calculations based on full mantle thickness, 72 of 138 through cracks occurred in total mantle thickness 2 mm, and the f/e ratio of through cracks in total mantles 2 mm thick was 3.5. The nding that cracks were not longer in thinmantle regions after loading was unexpected. It is generally presumed that thin-mantle regions combined with sharp corners of the stem can increase local mantle stresses, and thus the likelihood of mantle fracture [8,16]. However, using a torsional loading model of crack growth from the stem-cement interface, Hertzler et al. [17] found that the rate at which cracks grow from the stem-cement interface was not dependent on mantle thickness, ie, cracks did not grow faster in thin-mantle sections when compared with thick-mantle sections. This latter result is consistent with the present in vitro study; cracks did not grow faster in thin-mantle regions, but became through cracks in fewer loading cycles. A possible explanation for the presence of microcracks in these specimens is that they arise as an artifact from the sectioning process. This possibility is difcult to disprove directly, but several observations support the concept that these cracks are not caused by the sectioning process per se. First, loading of the bones causes an increase in total crack

density proportional to the applied load [10]. If caused by artifacts, one would not expect a difference in crack density caused by application of loading. Second, initial cracks were noted in other experimental models of stem-cement-bone constructs that neither were loaded nor sectioned [7], suggesting that it is possible to form microcracks before loads are applied. Finally, blocks of bulk cement that were not constrained during curing did not reveal any microcracks after sectioning and staining [10]. Based on the results from this study and placing these in context with at-autopsy retrievals and clinical studies, we propose the following scenario for mechanical loosening. Cracks exist as microcracks of short length at the time of the initial cement cure. The initial cracks may be over-represented in thin-mantle regions as a result of the cement curing process. Fatigue loading causes these cracks to grow in both length and number. Crack growth rate is not different for thin- versus thick-mantle regions. However, cracks become through cracks in thinmantle regions rst. These through microcracks could then open further, becoming true macrocracks and extend over a greater portion of the stem (construct) length. The through-crack fracture process would be detrimental from both a mechanical and biological perspective. Mechanically, cracks that extend between the stem to the bone could contribute to loss of component stability, because the cement mantle would no longer be able to support hoop stresses. This may not be a serious problem for regions in which the cement extends to the cortical wall, but could be much more worrisome in regions in which cancellous bone is present. Indeed, clinical studies in which cancellous bone is present between the cement mantle and cortical shell have higher incidences of loosening [1]. More biomechanical investigations are needed to determine the exact role of through cracks on stem xation. From a biological perspective, through cracks could act as conduits for debris between the stem and bone. If the stemcement interface has the potential to generate debris as a result of abrasion, then transfer of these small particles to the bone through cracks in the cement would be detrimental. Several studies have noted bone lysis in the vicinity of thin-mantle regions and have associated these with particulate PMMA [4,18]. With regard to surgical preparation of the femoral canal, it is benecial to leave the strong trabecular bone that is directly adjacent to the cortical bone during broaching of the femoral canal. This allows for interdigitation of the cement in the trabecular

612 The Journal of Arthroplasty Vol. 19 No. 5 August 2004 bone, which increases the strength of the cementbone interface [19]. Loosely attached trabecular bone that is farther from the cortical bone can be removed during broaching. This is therefore considered an aggressive broaching approach that will increase the size (thickness) of the cement mantle and should decrease risk of through cracks. The operative surgeon also should know the relationship between the diameter of the broach and the diameter of the stem that is implanted. This relationship is different for different broaching systems, and often varies over the range of implant sizes within the same system. It is imperative that the operative surgeon request specic information from the manufacturer of the femoral component, eg, the relationship that exists between the diameter of the broach and the diameter of the stem for each size implant available within the system. The surgeons choice of implant also may vary based on the size of the patients femoral canal and the relationship between the size of the broach and the size of the stem.
5. Kawate K, Maloney WJ, Bragdon CR, et al: Importance of a thin cement mantle: autopsy studies of eight hips. Clin Orthop Rel Res 355:70, 1998 6. Kadakia N, Noble P, Beardsley C, et al: Do cement voids casue premature failure of cement mantles in total hip arthroplasty. Trans Orthop Res Soc 46:221, 2000 7. McCormack BAO, Prendergast PJ: Microdamage accumulation in the cement layer of hip replacements under exural loading. J Biomech 32:467, 1999 8. Estok D, Orr T, Harris W: Factors affecting cement strains near the tip of a cemented femoral component. J Arthroplasty 12:40, 1997 9. Huiskes R: Some fundamental aspects of human joint replacement. Acta Orthop Scand 185(Suppl):109, 1980 10. Race A, Miller MA, Ayers DC, et al: Early cement damage around a femoral stem is concentrated at the cement/bone interface. J Biomech 36:489, 2003 11. Mann KA, Bartel DL, Wright TM, et al: Coulomb frictional interfaces in modeling cemented total hip replacements: A more realistic model. J Biomechanics 28:1067, 1995 12. Zar JH: Biostatistical Analysis. Upper Saddle River, NJ, Prentice-Hall, Inc., 1999 13. Valdivia GG, Dunbar MJ, Parker DA, et al: Three dimensional analysis of the cemented mantle in the total hip arthroplasty. Clin Orthop Rel Res 393:3851, 2001 14. Silva M, Shepherd E, Jackson W, et al: Average patient walking activity approaches 2 million cycles per year. J Arthroplasty 17:693, 2002 15. Jasty M, Maloney WJ, Bragdon CR, et al: Histomorphological studies of the long-term skeletal responses to well xed cemented femoral components. J Bone Joint Surg 72A:1220, 1990 16. Jasty M, Maloney WJ, Bragdon CR, et al: The initiation of failure in cemented femoral components of hip arthroplasties. J Bone Joint Surg 73B:551, 1991 17. Hertzler J, Miller MA, Mann KA: Fatigue crack growth rate does not depend on mantle thickness: an idealized cemented stem constructed under torsional loading. J Orthop Res 20:676, 2002 18. Maloney W, Jasty M, Rosenburg A, et al: Bone lysis in well xed femoral components. J Bone Joint Surg 72B:966, 1990 19. Mann KA, Ayers DC, Werner FW, et al: Tensile strength of the cement-bone interface depends on the amount of bone interdigitated with PMMA cement. J Biomech 30:339, 1997

Acknowledgments
The authors thank Matthew J. Allen, PhD, and Joanne E. Schoonmaker, AAS, for their assistance with staining and imaging.

References
1. Ebramzadeh E, Sarmiento A, McKellop HA, et al: The cement mantle in total hip arthroplasty: Analysis of long-term radiogaphic results. J Bone Joint Surg 76A: 77, 1994 2. Massoud SN, Hunter JB, Holdsworth BJ, et al: Early femoral loosening in one design of cemented hip replacement. J Bone Joint Surg 79B:603, 1997 3. Star MJ, Colwell CW, Kelman GJ, et al: Suboptimal (thin) distal cement mantle thickness as a contributory factor in total hip arthroplasty femoral component failure: a retrospective radiographic analysis favoring distal stem centralization. J Arthoplasty 9:143, 1994 4. Kawate K, Ohmura T, Hiyoshi N, et al: Thin cemented mantle and osteolysis with a precoated stem. Clin Orthrop Rel Res 365:124, 1999