The Validity of Bone Age Assessment by an Ultrasound Apparatus (SonicBone)
Condition: Bone Age
Study type: Observational

Summary: 
      Bone age assessment is currently an important tool in final height implication in children.
      It is an important tool in the phases of investigation and treatment of short stature, tall
      stature, pubertal timing and various endocrinological pediatric situations. It is currently
      assessed using hand x-ray. This method has several limitations, including: requirement of
      specialized medical staff to interpret results, exposure radiation and usage of equipment
      which is only in radiology centers. The investigators aim to study a new equipment, radiation
      free, with simple and swift operation which provides an immediate answer, no need for an
      experienced observer, a mobile equipment with easy accessibility. The aim of the study is to
      assess its reproducibility, validity and safety compared to the x-ray method.

      The investigators hypothesize it is as accurate and valid.
    

Detailed description: 
      Skeletal maturity assessment, defined also as bone age (BA), has an important role in
      pediatrics and pediatric endocrinology, used mainly for evaluating growth and puberty related
      endocrine disorders. Repeated BA assessment is important during the follow up of children
      with short stature, with precocious puberty and those treated by growth promoting
      medications.

      The most commonly used method used for determining skeletal maturity, and thus BA is based on
      comparison of a hand and wrist radiographs to a standard series of representative films in
      the "Radiographic atlas of skeletal development of the hand and wrist" by Greulich and Pyle
      (GP), which has been issued several decades ago. Among the disadvantages and drawbacks in
      this BA assessment method are: the obligatory need for using radiology units that are often
      available only in special facilities or hospitals, not available at the physicians office,
      the exposure to ionizing radiation, and the known limitation of the method for the need of an
      endocrinologist to assess the BA, with a known large inter observers variability of the BA
      interpretation.

      The suggested method in this study is based on ultrasound technology, and therefore it is
      quick, objective, and radiation-free. It delivers an immediate non biased result without the
      need to rely on an observer's evaluation of the hand radiograph and without the need for a
      specialized radiology facility.

      This technique was innovated in order to find an efficient, convenient and non radiation
      based method of skeletal maturity assessment for the primary care physician that can be
      performed in an office setting.

      The aim of this study is to establish a correlation algorithm between the BA assessment by an
      ultrasound apparatus (SonicBone) and the X-ray based assessment using Grulich and Pyle
      method, and to evaluate the validity and reproducibility of the apparatus, The design of the
      study is to perform a concomitant skeletal maturation assessment by reading of a hand X-ray
      radiograph by 3 experienced observers using the GP method, and by the ultrasound technique
      using the SonicBone apparatus. Skeletal maturation assessment will be performed in females
      and males at various age groups.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants are children and youth ages 4-17 years (inclusive) who performed or will
        perform a X-ray of the left hand for bone age assessment as part of any clinical work up,
        within 2 months of enrollment in this study.

        Participants will be recruited according to advertising the study amongst pediatricians,
        pediatric endocrinologists and from the pediatric population who visits the pediatric
        endocrine clinic, endocrine testing room, adolescent medicine clinic, or being hospitalized
        at the pediatric division, Assaf Haroffeh Medical Center.
      
Keywords: bone age; children; x-ray; ultrasound; ultrasound based method; safe; valid; reproducable