A new noninvasive mechanical bending test accurately predicts ulna bending strength in cadaveric human arms.

BACKGROUND: High error rates in the prediction of fragility fractures by bone mineral density have motivated searches for better clinical indicators of bone strength, and the high incidence of non-hip, non-spine fractures has raised interest in cortical bone. The aim of this study was to assess the accuracy of Cortical Bone Mechanics Technology™. CBMT is a new non-invasive 3-point bending technique for measuring the mechanical properties of cortical bone in the ulnas of living humans. METHODS: 35 cadaveric human arms were obtained from small women and large men ranging widely in age (17 < Age < 99 years) and body size (14 < BMI < 40 kg/m2). Noninvasive CBMT measurements of the flexural rigidity of the ulna bones within these arms (EICBMT) were compared to measurements of EI by Quasistatic Mechanical Testing in the ulnas excised from those arms (EIQMT). Ulna bending strength was also measured by QMT as the peak moment before fracture (Mpeak). The open source BoneJ plugin to ImageJ image processing software was used to calculate cortical porosity (CP) in micro-computed tomography images of a 2 mm length of the mid-shaft of each fractured ulna, and the interosseous diameter (IOD) of each ulna was also measured in those images. RESULTS: EICBMT measurements (13 < EICBMT < 97 Nm2) explained 99% of the variance in QMT measurements of ulna bending strength (11 < Mpeak < 90 Nm), but EICBMT was biased high by 30% (p < 0.0001) relative to EIQMT (11 < EIQMT < 69 Nm2). After correcting this bias, EICBMT and EIQMT measurements lay along the identity line (y = 1.00x, R2 = 0.99, SEE = 3.1 Nm2). Predictions of Mpeak by EICBMT were less accurate than predictions by EIQMT (both R2 = 0.99; SEECBMT = 5.9 Nm vs SEEQMT = 4.5 Nm, F = 2.92, p = 0.001), but EICBMT predictions were substantially more accurate than those by IOD (R2 = 0.79; SEEIOD = 10.6 Nm, F = 3.30, p < 0.001) and CP (R2 = 0.35; SEECP = 18.9 Nm, F = 10.45, p < 10-9). Predictions by EICBMT were also more accurate than predictions by arm donor height (R2 = 0.63; SEE = 14.3 Nm, F = 5.87, p < 10-6), body weight (R2 = 0.77; SEE = 11.1 Nm, F = 3.54, p < 0.001) and BMI (R2 = 0.64; SEE = 14.1 Nm, F = 2.39, p < 0.01). In forward stepwise multiple regression beginning with EICBMT, only age explained any additional variance in ulna bending strength (ΔR2 = 0.3%, F = 8.03, p = 0.008). CONCLUSION: Noninvasive CBMT measurements of ulna EI explain 99% of individual differences in QMT measurements of ulna bending strength in cadaveric human arms.

Accuracy and reproducibility of bending stiffness measurements by mechanical response tissue analysis in artificial human ulnas.

Osteoporosis is characterized by reduced bone strength, but no FDA-approved medical device measures bone strength. Bone strength is strongly associated with bone stiffness, but no FDA-approved medical device measures bone stiffness either. Mechanical Response Tissue Analysis (MRTA) is a non-significant risk, non-invasive, radiation-free, vibration analysis technique for making immediate, direct functional measurements of the bending stiffness of long bones in humans in vivo. MRTA has been used for research purposes for more than 20 years, but little has been published about its accuracy. To begin to investigate its accuracy, we compared MRTA measurements of bending stiffness in 39 artificial human ulna bones to measurements made by Quasistatic Mechanical Testing (QMT). In the process, we also quantified the reproducibility (i.e., precision and repeatability) of both methods. MRTA precision (1.0±1.0%) and repeatability (3.1 ± 3.1%) were not as high as those of QMT (0.2 ± 0.2% and 1.3+1.7%, respectively; both p<10(-4)). The relationship between MRTA and QMT measurements of ulna bending stiffness was indistinguishable from the identity line (p=0.44) and paired measurements by the two methods agreed within a 95% confidence interval of ± 5%. If such accuracy can be achieved on real human ulnas in situ, and if the ulna is representative of the appendicular skeleton, MRTA may prove clinically useful.