BONE SONOMETER

by Ultrasound Technology in Multizone
   
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Multi-Site Advantage
 Omnisense's unique probe technology is the only one of its kind. By enabling multi-site measurements, the Omnisense probe system provides you with greater diagnostic ability and enhanced measurement flexibility.
 Getting The Whole Picture
 Due to the systemic nature of Osteoporosis, having a multiple site option all picture of the skeleton and offers many advantages to the physician:
Combining measurement results of different skeletal sites can optimize fracture risk assessment. Using multiple measurement sites enables the physician to overcome the dilemma of how to diagnose patients who: 

  • have a clinical indication of osteoporosis but whose measurement results do not support this.

  • are not clearly defined and require a more conclusive diagnosis.

Monitoring Response To Treatment
 Different bones respond to treatment at varying rates and degrees. Using multi-site measurements, the physician can identify and monitor small bone changes in a relatively short period of time, allowing more effective monitoring and treatment decisions.

Exclusive Reference Database

The Omnisense includes a unique reference curve for each of the recommended skeletal sites:
the distal 1/3 radius, the mid-shaft tibia, the proximal third phalanx, and the fifth metatarsal.

Reference databases were collected in various geographic regions. All subjects were between the ages of 20 - 90 and met strict eligibility criteria. Each skeletal site was measured in accordance with Omnisense's strict measurement methodology. Omnisense reference databases currently support the following populations:

  • Caucasian (North America) - Male and Female

  • Asian - Male and Female

Peak Bone Strength
Data was collected and analyzed to establish the Omnisense reference curve and peak speed of sound (SOS) for each site.

The graph depicts SOS results as a function of age for the Caucasian female distal 1/3 radius. Note that the SOS increases to a peak of 4158 m/sec at the age of 41 with a population standard deviation of 102 m/sec, and declines thereafter.
Site Age of Peak Bone Strength
 Radius 41
 Phalanx 36
 Metatarsal 40
 Tibia 30

When comparing Omnisense SOS to bone density assessment devices such as DXA, SOS measurements peak at a later age, demonstrating that Omnisense SOS measurements reflect various bone properties. In addition to mineral density, SOS measurements take into consideration such bone properties as elasticity, cortical thickness, and micro-architecture.

 WHO Compliant

The Omnisense reference curve meets the WHO definition for osteoporosis, crossing the -2.5
T-score threshold at around the age of 75, similar to that of vertebral DXA.

Proven

Much discussion has been devoted to the appropriate sample size needed to establish a statistically significant reference database. Sunlight researchers have taken the initiative to gather measurement data from over 6000 subjects measured at 14 different centers from around the world. These subjects were not pre-selected nor were there any special qualification criteria applied to them. Both the system curve and the new curve were then compared by their mean and standard deviation. No statistical differences were found to exist, reinforcing the validity of the Omnisense reference curve.

WHO Criteria

The World Health Organization (WHO) has defined criteria for assessing bone status and determining the risk of fracture (Osteoporosis)*. These criteria are defined by "T-score," which is the number of standard deviations by which a subject's result exceeds (positive T-score) or falls below (negative T-score) the mean of the young adult group.
 Normal healthy bone  =        -1<T-Score
 Osteopenia  =        -2.5 <T-Score <-1
 Osteoporosis  =        T-Score <-2.5
 Severe Osteoporosis  =        T-score <-2.5 and an evidence   
      of a low trauma fracture

Database Comparison
When comparing reference data curves of various bone assessment devices in terms of T-score, we find that the Omnisense radius reference curve crosses the -2.5 T-score level at the same age range as that of DXA of the spine and forearm, thereby demonstrating that WHO criteria for the definition of osteoporosis can be confidently applied to Omnisense measurements.


1.The curves of the L2-L4 spine DXA, the forearm DXA, and Omnisense radius cross the -2.5 threshold at around the age of 75.

2.Omnisense prevalence of osteoporosis is around 35% in the 60-90 North American female population age group.

*WHO Technical Report Series, Geneva 1994; M. Weiss.

 

    

 

 

PREMIERTM

 

Premier Bone Assessment for the First Months of Life
PREMIERTM provides the only method available for the safe and accurate bone assessment of pre-term infants. The widespread prevalence of Osteopenia of Prematurity among pre-term infants makes PREMIERTM an essential tool in hospital neonatal units.

 The Need for Pre-term Bone Assessment
 Pre-term babies don’t achieve the bone mass normally accreted during the third trimester of pregnancy, and are often born with low bone mineralization. Days or weeks spent in NICUs further slow their bone development.
 PREMIERTM enables tracking of neonate bone, using patented Omnipath™ technology, to identify babies whose bones are underdeveloped.

Tracking Bone Development
PREMIERTM provides non-invasive and radiation-free measurement with a mobile, compact and user-friendly device especially developed for the measurement of pre-term infants. Its low measurement error provides sensitivity to small changes in the bone and permits frequent monitoring of premature infant bone.
PREMIERTM automatically compares Speed of Sound measurements to a built-in reference database which portrays the intrauterine development curve of healthy bone.

 

 

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