Modification to Mirels scoring system location component improves fracture prediction for metastatic disease of the proximal femur.

BACKGROUND: Correctly identifying patients at risk of femoral fracture due to metastatic bone disease remains a clinical challenge. Mirels criteria remains the most widely referenced method with the advantage of being easily calculated but it suffers from poor specificity. The purpose of this study was to develop and evaluate a modified Mirels scoring system through scoring modification of the original Mirels location component within the proximal femur. METHODS: Computational (finite element) experiments were performed to quantify strength reduction in the proximal femur caused by simulated lytic lesions at defined locations. Virtual spherical defects representing lytic lesions were placed at 32 defined locations based on axial (4 axial positions: neck, intertrochanteric, subtrochanteric or diaphyseal) and circumferential (8 circumferential: 45-degree intervals) positions. Finite element meshes were created, material property assignment was based on CT mineral density, and femoral head/greater trochanter loading consistent with stair ascent was applied. The strength of each femur with a simulated lesion divided by the strength of the intact femur was used to calculate the Location-Based Strength Fraction (LBSF). A modified Mirels location score was next defined for each of the 32 lesion locations with an assignment of 1 (LBSF > 75%), 2 (LBSF: 51-75%), and 3 (LBSF: 0-50%). To test the new scoring system, data from 48 patients with metastatic disease to the femur, previously enrolled in a Musculoskeletal Tumor Society (MSTS) cross-sectional study was used. The lesion location was identified for each case based on axial and circumferential location from the CT images and assigned an original (2 or 3) and modified (1,2, or 3) Mirels location score. The total score for each was then calculated. Eight patients had a fracture of the femur and 40 did not over a 4-month follow-up period. Logistic regression and decision curve analysis were used to explore relationships between clinical outcome (Fracture/No Fracture) and the two Mirels scoring methods. RESULTS: The location-based strength fraction (LBSF) was lowest for lesions in the subtrochanteric and diaphyseal regions on the lateral side of the femur; lesions in these regions would be at greatest risk of fracture. Neck lesions located at the anterior and antero-medial positions were at the lowest risk of fracture. When grouped, neck lesions had the highest LBSF (83%), followed by intertrochanteric (72%), with subtrochanteric (50%) and diaphyseal lesions (49%) having the lowest LBSF. There was a significant difference (p < 0.0001) in LBSF between each axial location, except subtrochanteric and diaphyseal which were not different from each other (p = 0.96). The area under the receiver operator characteristic (ROC) curve using logistic regression was greatest for modified Mirels Score using site specific location of the lesion (Modified Mirels-ss, AUC = 0.950), followed by a modified Mirels Score using axial location of lesion (Modified Mirels-ax, AUC = 0.941). Both were an improvement over the original Mirels score (AUC = 0.853). Decision curve analysis was used to quantify the relative risks of identifying patients that would fracture (TP, true positives) and those erroneously predicted to fracture (FP, false positives) for the original and modified Mirels scoring systems. The net benefit of the scoring system weighed the benefits (TP) and harms (FP) on the same scale. At a threshold probability of fracture of 10%, use of the modified Mirels scoring reduced the number of false positives by 17-20% compared to Mirels scoring. CONCLUSIONS: A modified Mirels scoring system, informed by detailed analysis of the influence of lesion location, improved the ability to predict impending pathological fractures of the proximal femur for patients with metastatic bone disease. Decision curve analysis is a useful tool to weigh costs and benefits concerning fracture risk and could be combined with other patient/clinical factors that contribute to clinical decision making.

Damage in total knee replacements from mechanical overload.

The mechanical loads acting across the knee joint following total knee replacements (TKR) during activities of daily living have recently been measured using instrumented TKRs. Using a series of postmortem retrieved TKR constructs we investigated whether these mechanical loads could result in damage to the implant bone interface or supporting bone in the tibia. Eighteen cemented en bloc tibial components (0 to 22 years in service) were loaded under axial compression in increments from 1 to 10 times body weight and digital image correlation was used to measure bone strain and interface micromotion during loading and unloading. Failure was considered to occur when micromotion exceeded 150µm or compressive bone strain exceeded 7300µÎµ. The results show that all retrieved specimens had sufficient bone strength to support most activities of daily living, but ~40% would be at risk under larger physiologic loads that might occur secondary to a higher impacts such as jogging or a stumble. The tray-bone micromotion (regression model R(2)=0.48, p=0.025) was greater for donors with lower age at implantation (p=0.0092). Proximal bone strain (model R(2)=0.46, p=0.03) was greater for donors with longer time in service (p=0.021). Distal bone strain (model R(2)=0.58, p=0.005) was greater for donors with more time in service (p=0.0054) and lower peri-implant BMD (p=0.049). High mechanical overload of a single or repetitive nature may be an initiating factor in aseptic loosening of total joint arthroplasties and should be avoided in order to prolong the life of the implant.

Simulating activities of daily living with finite element analysis improves fracture prediction for patients with metastatic femoral lesions.

Predicting fracture risk for patients with metastatic femoral lesions remains an important clinical problem. Mirels' criterion remains the most formalized radiographic scoring system with good sensitivity (correctly identifying clinical fractures) but relatively poor specificity (correctly identify cases that do not fracture). A series of patients with metastatic femoral lesions had Computed Tomography (CT) scans, were followed prospectively for 4 months, and categorized into fracture (n = 5), non-fracture (n = 28), or stabilized (n = 11) groups. CT based-Finite Element (FE) modeling was used to predict fracture for these cases using axial compression (AC), level walking (LW), and aggressive stair ascent (ASA) loading conditions. The FE predicted fracture force was greater for the non-fracture compared to the fracture group for all loading cases. The ability of the FE models to predict fracture cases (sensitivity) was similar for the groups (Mirels, AC, LW: 80%, ASA: 100%). The ability of the models to correctly predict the non-fracture cases (specificity) was improved for AC (71%) and LW (86%) loading conditions, when compared to Mirels specificity (43%), but poorer for the ASA (21%) conditions. The results suggest that FE models that assess fracture risk using LW conditions can improve fracture prediction over Mirels scoring in a clinical population.

Peri-implant bone strains and micro-motion following in vivo service: a postmortem retrieval study of 22 tibial components from total knee replacements.

Biological adaptation following placement of a total knee replacements (TKRs) affects peri-implant bone mineral density (BMD) and implant fixation. We quantified the proximal tibial bone strain and implant-bone micro-motion for functioning postmortem retrieved TKRs and assessed the strain/micro-motion relationships with chronological (donor age and time in service) and patient (body weight and BMD) factors. Twenty-two tibial constructs were functionally loaded to one body weight (60% medial/40% lateral), and the bone strains and tray/bone micro-motions were measured using a digital image correlation system. Donors with more time in service had higher bone strains (p = 0.044), but there was not a significant (p = 0.333) contribution from donor age. Donors with lower peri-implant BMD (p = 0.0039) and higher body weight (p = 0.0286) had higher bone strains. Long term implants (>11 years) had proximal bone strains 900 µÏµ that were almost twice as high as short term (<5 years) implants 570 µÏµ. Micro-motion was greater for younger donors (p = 0.0161) and longer time in service (p = 0.0008). Increased bone strain with long term in vivo service could contribute to loosening of TKRs by failure of the tibial peri-implant bone.

Loss of cement-bone interlock in retrieved tibial components from total knee arthroplasties.

BACKGROUND: Aseptic loosening continues to be a short- and long-term complication for patients with cemented TKAs. Most studies to this point have evaluated tibial component fixation via radiographic changes at the implant-bone interface and quantification of component migration; direct assessment of morphologic features of the interface from functioning TKAs may provide new information regarding how TKAs function and are fixed to bone. QUESTIONS/PURPOSES: In a postmortem retrieval study, we asked: (1) What are the morphologic features at the cement-trabecular bone interface in retrieved tibial components? (2) Do constructs with greater time in service have less cement-trabecular bone interlock? (3) Do constructs with more estimated initial interlock sustain more interlock with in vivo service? METHODS: Fourteen postmortem retrieved tibial components with time in service from 0 to 20 years were sectioned and imaged at high resolution, and the current contact fraction, estimated initial interdigitation depth, current interdigitation depth, and loss of interdigitation depth were quantified at the cement-bone interface. Estimated initial interdigitation depth was calculated from the initial mold shape of the cement mantle that forms around the individual trabeculae at the time of surgery. Loss of interdigitation depth was the difference between the initial and current interdigitation depth. RESULTS: There was resorption of trabeculae that initially interlocked with the cement in the postmortem retrievals as evidenced by the differences between current interdigitation and the estimated original interdigitation. The current contact fraction (r(2) = 0.54; p = 0.0027) and current interdigitation depth (r(2) = 0.33; p = 0.033) were less for constructs with longer time in service. The current contact fraction for implants with 10 or more years in service (6.2%; 95% CI, 4.7%-7.7%) was much less than implants with less than 10 years in service (22.9%; 95% CI, 8.9%-37%). Similarly, the current interdigitation depth for implants with 10 or more years in service (0.4 mm; 95% CI, 0.27-0.53 mm) was much less than implants with less than 10 years in service (1.13 mm; 95% CI, 0.48-1.78 mm). The loss of interdigitation depth had a strong positive relationship with time in service (r(2) = 0.74; p < 0.001). Using a two-parameter regression model, constructs with more initial interdigitation depth had greater current interdigitation depth (p = 0.011), but constructs with more time in service also had less current interdigitation depth (p = 0.008). CONCLUSIONS: The cement-trabecular bone interlock obtained initially appears to diminish with time with in vivo service by resorption of the trabeculae in the cement interlock region. CLINICAL RELEVANCE: Our study supports the surgical concept of obtaining sufficient initial cement interlock (approximately 3 mm), with the acknowledgment that there will be loss of interlock with time with in vivo service.

Micromechanics of postmortem-retrieved cement-bone interfaces.

The cement-bone interface plays an important role in load transfer between cemented implant systems and adjacent bone, but little is known about the micromechanical behavior of this interface following in vivo service. Small samples of postmortem-retrieved cement-bone specimens from cemented total hip replacements were prepared and mechanically loaded to determine the response to tensile and compressive loading. The morphology of the cement-bone interface was quantified using a CT-based stereology approach. Laboratory-prepared specimens were used to represent immediate postoperative conditions for comparison. The stiffness and strength of the cement-bone interface from postmortem retrievals was much lower than that measured from laboratory-prepared specimens. The cement-bone interfaces from postmortem retrievals were very compliant (under tension and compression) and had a very low tensile strength (0.21 +/- 0.32 MPa). A linear regression model, including interface contact fraction and intersection fraction between cement and bone, could explain 71% (p < 0.0001) of the variability in experimental response. Bony remodeling following an arthroplasty procedure may contribute to reduced contact between cement and bone, resulting in weaker, more compliant interfaces.

Experimental micromechanics of the cement-bone interface.

Despite the widespread use of cement as a means of fixation of implants to bone, surprisingly little is known about the micromechanical behavior in terms of the local interfacial motion. In this work, we utilized digital image correlation techniques to quantify the micromechanics of the cement-bone interface of laboratory-prepared cemented total hip replacements subjected to nondestructive, quasistatic tensile and compressive loading. Upon loading, the majority of the displacement response localized at the contact interface region between cement and bone. The contact interface was more compliant (p = 0.0001) in tension (0.0067 +/- 0.0039 mm/MPa) than compression (0.0051 +/- 0.0031 mm/MPa), and substantial hysteresis occurred due to sliding contact between cement and bone. The tensile strength of the cement-bone interface was inversely proportional to the compliance of the interface and proportional to the cement/bone contact area. When loaded beyond the ultimate strength, the strain localization process continued at the contact interface between cement and bone with microcracking (damage) to both. More overall damage occurred to the cement than to the bone. The opening and closing at the contact interface from loading could serve as a conduit for submicron size particles. In addition, the cement mantle is not mechanically supported by surrounding bone as optimally as is commonly assumed. Both effects may influence the longevity of the reconstruction and could be considered in preclinical tests.

Stem-cement porosity may explain early loosening of cemented femoral hip components: experimental-computational in vitro study.

A combination of laboratory experiment and computational simulation was performed to assess the role of interface porosity on stem migration. The early motion of in vitro prepared cemented femoral components was measured during application of cyclic stair climbing loads. Following testing, transverse sections were obtained and the distribution of pores at the stem-cement interface was determined. Finite element models of cemented stem constructs were developed and a scheme was implemented to randomly assign pores to the stem-cement interface. For a series of 14 in vitro prepared components, pore fractions at the stem-cement interface ranged from 23% to 67%. The majority of pores at the stem-cement interface were less than 1 mm in length with a mean length of 1.27 +/- 2.7 mm and thickness of 0.12 +/- 0.11 mm. For stems with large pore fractions, pores tended to coalesce in longer extended gaps over the stem surface. Finite element and experimental models both revealed strong positive correlations (r(2) = 0.55-0.72; p < 0.0001) between stem-cement pore fraction and stem internal rotation, suggesting that the presence and extent of pores could explain the early motion of the stems. There was an increased volume of cement at risk of fatigue failure with increasing stem migration. Pore fractions greater than 30% resulted in large increases in stem internal rotation, suggesting that attempts to maintain surface porosity at or below this level may be desirable to minimize the risk of clinical loosening.

Cement microcracks in thin-mantle regions after in vitro fatigue loading.

An in vitro study of cemented femoral hip components was conducted to determine if microcracks in the cement mantle would preferentially form in thin-mantle 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-fixed femoral components and supports the general guideline that thin-mantle regions should be avoided in the cementing of the femoral stem.

Application of circular statistics in the study of crack distribution around cemented femoral components.

Cemented stem constructs were loaded in cyclic fatigue using stair climbing loading and the resulting fatigue damage to the cement mantle was determined in terms of angular position of crack and crack length. Techniques from circular statistics were used to determine if the distribution of micro-cracks was uniform. With a designated orientation of 0 degrees -90 degrees -180 degrees -270 degrees indicating lateral-anterior-medial-posterior anatomic directions, the overall distribution of cracks was not uniform (p<0.05) with a mean crack direction in the postero-medial (249 degrees) quadrant of the mantle. The crack angular distribution for proximal (postero-medial; 251 degrees) and distal (antero-medial; 112 degrees) regions of the cement mantle was also different (p<0.025). These findings suggest that the location of cement damage depends on anatomic position and appears to correspond with the tensile stress field in the cement mantle.