OMNISENSE 7000S/8000S

Clinical Summary #5

  Discrimination of Proximal Hip Fracture by  
Quantitative Ultrasound Measurement at the Radius

M. Weiss, A. Ben-Shlomo, P. Hagag, and S. Ish-Shalom 
Osteoporosis Int. (2000) 11:411-416


Omnisense demonstrates its ability to assess hip fracture risk of subjects by speed of sound measurements at the radius.

Introduction
Osteoporosis is a disease that culminates with fragility fractures and imposes a major burden on health care costs. In dealing with this worldwide condition, it is prudent to use a reliable, non-expensive, portable diagnostic device that does not use ionizing radiation and is capable of measuring bone properties at several sites. Sunlight Omnisense 7000S, a quantitative ultrasound device which measures the speed of sound (SOS) along the bone at multiple skeletal sites, provides such a solution.

Study Design
The study was designed to evaluate the ability of the Omnisense to assess fracture risk. Three groups of women were recruited for this cross-sectional study:

  • Elderly women with osteoporotic proximal hip fractures
  • Elderly women without any evidence of osteoporotic fractures
  • Young, healthy women 

Speed of Sound measurements were performed at the distal 1/3 of the radius.

Results
SOS was found to be significantly lower in the fractured group than in the non-fractured group. Hip fracture subjects had a mean speed of sound (SOS) of 3861±149 m/s, while non-fracture subjects had a mean SOS of 3966±145 m/s. Thus, there was a difference of 105 m/s between the two groups (t-test p<0.0001).  A low SOS is an indication of unhealthy bone and increased fracture risk (ROC curves indicate an AUC of 0.79 (95% CI, 0.73 - 0.86)). Assessment of fracture risk can presented by odds ratio (OR). In this study, OR was 2.16 (95% CI, 1.46 - 3.19). This analysis shows that for every 100 m/s decrease in SOS the odds of fracture increase by about 50% and that for every decrease of 162 m/s in SOS the odds of fracture double.

T-Score Discrimination by Age

Graphics (p.1-3)

Conclusion
SOS, as measured by the Omnisense, can be considered an important factor in aiding the physician when diagnosing a patient for osteoporosis and determining the patient's risk of fracture.

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