Strain response of an instrumented intramedullary nail to three-point bending.

OBJECTIVES: An experimental biomechanical evaluation of an instrumented intramedullary nail (TriGen® META Nail, Smith&Nephew®) was undertaken. The objectives were two-fold. The first was to identify the most sensitive strain gauge positions and orientations on the nail, and the second was to demonstrate that the nail was capable of detecting changes in stiffness of the nail-bone composite. The function of the instrumented nail is to quantify fracture healing objectively and directly, and so to predict delayed repair or non-union 2 months before current methods. METHODS: Eight flat pockets were machined onto the surface of the nail and three strain gauges attached in each pocket. The instrumented nail was inserted into fourth generation biomechanical grade Sawbones® tibiae with three different fracture configurations as well as into a non-fractured bone. The nail-bone composite was loaded in three-point bending at five positions to determine the strain changes in each of the eight strain gauge pockets located along the length of the nail. To simulate callus in the simplest way and to increase the stiffness of the nail-bone composite, loops of duct tape in multiples of four were applied over the fracture locus. A three-point loading jig was used to obtain the change in strain with increasing stiffness. Relative displacement of the bone ends was quantified using radiostereometric analysis. RESULTS: There was no single position of greatest strain sensitivity for all fracture types. The greatest change in strain occurred when the strain gauge pocket and fracture line were closest. Applying the loading moment directly over the strain gauge pocket also maximised its sensitivity. The duct tape callus simulation showed that the instrumented nail was able to detect a change in stiffness of less than 4.1 Nm/°. CONCLUSIONS: It has been shown that the instrumented nail can detect physiologically relevant changes in stiffness, and so to provide a useful function as an objective monitor of fracture repair.

A single-channel telemetric intramedullary nail for in vivo measurement of fracture healing.

OBJECTIVE: The objective of this study was to develop a single-channel telemetric intramedullary nail that measures anterior-posterior bending strains and determine whether these forces decrease sigmoidally when normalized to the ground reaction force during fracture healing. METHODS: A transverse midshaft femoral osteotomy (1 mm) was stabilized using a customized TriGen intramedullary nail incorporating a strain gauge in the anterior-posterior plane. Fourteen skeletally mature sheep (2-3 years old) were treated in two pilot studies (n = 3/pilot) and a pivotal study (n = 8). Three animals were excluded as a result of welfare issues. Static strain measurements were acquired at approximately 130 Hz during leg stance. In vivo gait analysis was carried out weekly to assess ground reaction forces and biweekly x-rays to assess stability and fracture healing. Animals were euthanized 12 weeks postoperatively. Callus formation was assessed by microcomputed tomography and histomorphometry. The degree of load share between bone and the nail was determined postmortem by three-point bending. RESULTS: A significant preload was generated during implantation, most notably during placement of the four interlocking screws and by the action of attached soft tissues. Eight animals showed evidence of bone healing by x-ray, microcomputed tomography, and histology. However, a reduction in implant load was only observed with two of the eight. The degree of load sharing observed in vivo in these animals (50%-75%) compared favorably with the in vitro observations (approximately 50%). In the nonhealing ambulating animals, nail forces did not change over time. Three-point bend tests carried out on "healed" femurs suggested that load sharing between the bone and nail could be detected more easily in the absence of soft tissues. CONCLUSION: No clear correlation between implant strain and fracture healing was observed using the single-channel system when subjected to one external loading regime (leg stance phase). However, ex vivo biomechanical testing demonstrated that load share changes could be detected when loads were directly applied to the bone in the absence of muscle and ligament forces. These data emphasize the need to fully characterize the complex biomechanical environment of the limb to determine the load changes resulting from fracture healing.

Evaluation of a synthetic vertebral body augmentation model for rapid and reliable cyclic compression life testing of materials for balloon kyphoplasty.

Screening of augmentation materials for use in balloon kyphoplasty (BKP) may be carried out using vertebral bodies (VBs) prepared from fresh cadaveric or animal model spines, but this approach has many drawbacks. Alternatively, a validated synthetic VB augmentation model may be used. In the present work, such a model-a cube (26 mm sides) of low-density polyurethane foam with a centrally located through-thickness cylindrical hole (diameter = 4 mm) completely filled with a bolus of augmentation material-was used to compare two BKP augmentation materials with very different chemistries (a high-viscosity acrylic bone cement (PMMA) and a calcium phosphate bone substitute (CP)) in cyclic compression life tests. The test conditions were considered physiologically relevant: the model was immersed in phosphate buffered saline solution, at 37 degrees C; the frequency was 3 Hz; and the maximum load was either 1150 N or 2300 N (corresponding to a maximum stress of 1.7 or 3.4 MPa). At the high load, all four PMMA and two out of seven CP specimens ran out to 1 million cycles. CP specimens consistently ran out at the low load. The use of this model for rapid and reliable ex vivo screening of BKP augmentation materials was considered both valid (because of the clear demarcation seen in the qualitative and quantitative results obtained with the two materials tested) and appropriate (that is, clinically relevant to BKP).

Preheating acrylic bone cement powder is not recommended for all brands.

One strategy that has been suggested for reducing the operating room time for cemented total joint arthroplasties-and, hence, for reducing the total cost of these procedures-is to accelerate the polymerization of the acrylic bone cement by preheating the powder to 65 degrees C. We quantified the effect of preheating the cement powders on the fracture toughness and fatigue life of 3 cement brands that are widely used in clinical practice. The results suggest judicious selection of cements whose powders are to be preheated for use in cemented arthroplasties.

Estimation of the optimum loading of an antibiotic powder in an acrylic bone cement: gentamicin sulfate in SmartSet HV.

BACKGROUND: In some countries, commercially available antibiotic powder-loaded acrylic bone cement is routinely used in joint replacement, while, in others, "off-label" formulations are used in selected procedures (where the antibiotic powder is blended manually with the powder of a plain cement in the operating room/theater by either the surgeon or approved personnel). In the latter situation, an arbitrary rather than a rational approach is used for deciding on the amount of the antibiotic that is blended with the cement powder (herein referred to as "the antibiotic powder loading"). METHODS AND RESULTS: The first objective of this study was to present two methods for estimating the optimum loading of gentamicin sulfate powder that may be blended manually with the powder of a commercially available acrylic bone cement, ABC (Wopt). The second objective was to define the challenges associated with each of these methods. The loading (W) was optimized with respect to two key properties of the cured cement that were obtained simultaneously, namely (1) fatigue life in phosphate-buffered saline solution (PBS) at 37 degrees C, and (2) the rate of elution of the gentamicin from the cement (E) in that medium. Three sets of specimens were used, containing 2.25, 4.25 and 11.50 wt/wt% of the gentamicin that was blended manually with the cement powder. The fatigue tests involved determining the number of cycles at which a specimen fractured (Nf) when subjected to fully-reversed tension-compression sinusoidal load, +/- 15 MPa at 2 Hz. E was determined from the concentration of gentamicin in the PBS solution when the specimen fractured, using fluorescence polarization immunoassay for the measurement. Consistent with a priori expectations, it was found that, with increase in W, Nf decreased while E increased. Two approaches for obtaining an estimate of Wopt are described, a mathematical method and an empirical one, that lead to Wopt values of 6.50 wt/wt% and 4.78 wt/wt%, respectively. Thus, this antibiotic loading ranges from about the same to about 92% greater than that in SmartSet GHV Gentamicin, which is a commercially available bone cement used clinically and which has the same composition as SmartSet HV except for the presence of gentamicin sulfate in its powder (blended in by the manufacturer). INTERPRETATION: We present and critically compare two rational methods of determining the optimum loading of an antibiotic powder in an acrylic bone cement, which should serve as a guide when using "off-label" antibiotic powder-loaded acrylic bone cements in cemented joint replacements.

Alendronate in bone cement: fatigue life degraded by liquid, not by powder.

Bisphosphonates have the potential to reduce osteolysis, a phenomenon that has been postulated to play a key role in aseptic loosening of total joint replacements. Bisphosphonates may contribute to the in vivo longevity of total joint replacements. Some authors have suggested there are decreases in flexural strength and flexural modulus of the cured cement when a liquid form of disodium pamidronate is added to a commercially available acrylic bone cement (Palacos R). We proposed that it is comparatively easier to blend a bisphosphonate in powder form into an acrylic bone cement than it is when the drug is in liquid form; and that the cement's fatigue life is decreased when the bisphosphonate is added in liquid rather than in solid form. The bisphosphonate and bone cement used were alendronate sodium and Cemex XL, respectively. The fatigue tests were done using phosphate buffered saline solution at 37 degrees +/- 1 degrees C. The data supported both hypotheses. Our findings should guide orthopaedic surgeons when using bisphosphonate-impregnated acrylic bone cements in total joint replacements. Bisphosphonates are endogenous pyrophosphate analogs in which a carbon atom replaces the central oxygen atom. These therapeutic agents may be classified into nitrogen and non-nitrogen containing types. Some examples are alendronate, pamidronate, ibandronate, risedronate, etidronate, clodronate, and zoledronate. There are many targets and mechanisms of action of this family of drugs, therefore making them efficacious against diverse clinical conditions such as osteoporosis, periprosthetic bone loss subsequent to total joint replacement, tumor cell proliferation, apoptosis and angiogenesis, Charcot neuroarthropathy, rheumatoid arthritis, ankylosing spondylitis and spondyloarthropathies, and arterial calcification. It has been proposed that some bisphosphonates are effective against the mechanisms that have been suggested as being implicated in aseptic loosening of total joint replacements, these being osteoclast-mediated bone resorption and wear particle-induced osteolysis. A meta-analysis of randomized controlled trials showed that alendronate and pamidronate had beneficial effects maintaining periprosthetic bone for as much as 1 year after a total joint replacement.

Influence of the method of blending an antibiotic powder with an acrylic bone cement powder on physical, mechanical, and thermal properties of the cured cement.

Two variants of antibiotic powder-loaded acrylic bone cements (APLBCs) are widely used in primary total joint replacements. In the United States, the antibiotic is manually blended with the powder of the cement at the start of the procedure, while, in Europe, pre-packaged commercially-available APLBCs (in which the blending is carried out using an industrial mixer) are used. Our objective was to investigate the influence of the method of blending gentamicin sulphate with the powder of the Cemex XL formulation on a wide collection of properties of the cured cement. The blending methods used were manual mixing (the MANUAL Set), use of a small-scale, easy-to-use, commercially-available mechanical powder mixer, OmoMix 1 (the MECHANICAL Set), and use of a large-scale industrial mixer (Cemex Genta) [the INDUSTRIAL Set]. In the MECHANICAL and MANUAL Sets, the blending time was 3 min. In preparing the test specimens for each set, the blended powder used contained 4.22 wt% of the gentamicin powder. The properties determined were the strength, modulus, and work-to-fracture (all obtained under four-point bending), plane-strain fracture toughness, Weibull mean fatigue life (fatigue conditions: +/-15 MPa; 2 Hz), activation energy and frequency factor for the cement polymerization process (both determined using differential scanning calorimetry, at heating rates of 5, 10, 15, and 20 Kmin(-1)), the diffusion coefficient for the absorption of phosphate buffered saline, PBS, at 37 degrees C, and the rate of elution of the gentamicin into PBS, at 37 degrees C (E). Also determined were the particle size, particle size distribution, and morphology of the blended powders and of the gentamicin. For each of the cured cement properties (except for E), there is no statistically significant difference between the means for the 3 cements, a finding that parallels the observation that there are no significant differences in either the mean particle size or the morphology of the blended cement powders. Notwithstanding these results, it is suggested that when the powder mixture is blended in the operating room, using the OmoMix 1 is more likely to produce a more consistent and reproducible mixture than when manual mixing is used.

The in vitro elution of gentamicin sulfate from a commercially available gentamicin-loaded acrylic bone cement, VersaBond AB.

The present study was designed to yield results that would be used to contribute to the ongoing debate about the mechanism of the in vitro elution of an antibiotic from an antibiotic-loaded acrylic bone cement. To this end, the elution rates (R) of gentamicin sulfate (expressed as a weight percentage of the initial mass of the antibiotic in the specimen, normalized with respect to the duration of the test) from statically loaded (STATIC) and dynamically loaded (+/-10 MPa; 2 Hz; until fracture; DYNAMIC) specimens fabricated from a commercially available acrylic bone cement (VersaBond AB), in phosphate-buffered saline solution at 37 degrees C, were obtained with the use of a spectrophotometric method. There was evidence of microcracking in the fracture surfaces of DYNAMIC specimens, but no such evidence in the case of STATIC specimens. The surface area of the DYNAMIC specimens, during the tensile phase of the cyclical loading, was estimated to be about 3% larger than for the STATIC specimens (1742 mm(2) versus 1696 mm(2)). The bulk porosities P of the specimens in both sets were also determined and found to not be statistically different, with P for the STATIC and DYNAMIC specimens being 8.55 +/- 0.10 and 8.88 +/- 0.18%, respectively. At the end of the test period, R was found to be 0.36 +/- 0.20 and 1.28 +/- 0.14 wt %/day for the STATIC and DYNAMIC specimens, respectively. It is suggested that the present results provide support for the postulate that the elution mechanism of gentamicin in this cement is a surface phenomenon.

The influence of the viscosity classification of an acrylic bone cement on its in vitro fatigue performance.

The goal of the present work was to investigate the influence of the viscosity classification of an acrylic bone cement on its in vitro fatigue performance, as determined in fully-reversed tension-compression (+/-15 MPa) fatigue tests. The test matrix comprised six commercially available bone cements [Orthoset1, (OS1), Orthoset(R)3 (OS3), CemexRX (CRX), Cemex XL (CXL), Palacos R (PR) and Osteopal (OP)], two methods of mixing the cement constituents (hand-mixing and vacuum-mixing), two methods of fabricating the test specimens (direct molding and molding followed by machining), two specimen cross-sectional shapes (rectangular or "flat" and circular or "round"), and four test frequencies (1, 2, 5, and 10 Hz). In total, 185 specimens, distributed among 20 sets, were tested. The test results (number of fatigue stress cycles, N_f) were processed using the linearized transformation of the three-parameter Weibull distribution, whence estimates of the Weibull mean, N_[WM], were obtained. Statistical analysis of the ln N_f results (Mann-Whitney test; alpha<0.05) and a comparison of the N_[WM] estimates for specimen sets in which the formulations have essentially the same composition but different viscosity classification (namely, OS1 versus OS3, CRX versus CXL, and PR versus OP) showed that, in the majority of the comparisons carried out, the viscosity classification of a bone cement does not exert a significant influence on its in vitro fatigue performance.

Effect of test specimen cross-sectional shape on the in vitro fatigue life of acrylic bone cement.

Constant-amplitude uniaxial tension-compression fatigue tests were conducted on specimens fabricated from 12 sets of acrylic bone cements, covering cement formulations with three different viscosities (so-called "high-", "medium-" and "low-viscosity" varieties), two different methods of mixing the cement constituents (so-called "hand-" and "vacuum-mixed" methods) and two test specimen shapes (rectangular-cross-sectioned or "flat" and circular-cross-sectioned or "round"). The test results-namely, the number of fatigue stress cycles, N(f)-were analyzed using the linearized transformation of the three-parameter Weibull relationship, allowing the values of the Weibull mean, N(WM), to be determined for each set. Values ranged from 14,300 to 1,284,331 for the round specimen sets and from 2898 to 72,960 for the flat specimen sets. Statistical analysis of the ln N(f) data, together with an examination of the N(WM) values, showed that, for any combination of cement formulation and mixing method, round specimens had significantly longer fatigue lives compared to flat ones. These results are explained in terms of two factors. The first is the smaller surface area of the waisted zone in the round specimens compared to that in the flat specimens (nominal value of 157mm(2) versus nominal value of 185mm(2)), leading to the possibility of fewer crack initiation sites on the round specimens compared to the flat ones. Secondly, it is postulated that the crystallinity of the round specimens was higher than that of the flat ones, a consequence of the significantly lower measured residual liquid monomer contents of the former compared to the latter (3.40+/-1.28wt%/wt compared to 3.81+/-1.48wt%/wt). The significance of the present finding is that it indicates that, for a set of bone cement formulation and experimental conditions, discriminating fatigue test results are more likely to be obtained if flat, rather than round, test specimens are used.

Effect of test frequency on the in vitro fatigue life of acrylic bone cement.

The goal of the present work was to test the hypothesis that test frequency, f, does not have a statistically significant effect on the in vitro fatigue life of an acrylic bone cement. Uniaxial constant-amplitude tension-compression fatigue tests were conducted on 12 sets of cements, covering three formulations with three very different viscosities, two different methods of mixing the cement constituents, and two values of f (1 and 10 Hz). The test results (number of fatigue stress cycles, N(f)) were analyzed using the linearized form of the three-parameter Weibull equation, allowing the values of the Weibull mean (N(WM)) to be determined for each set. Statistical analysis of the lnN(f) data, together with an examination of the N(WM) estimates, showed support for the hypothesis over the range of f used. The principal use and explanation of the present finding are presented.