The aim of this project is to develop a novel portable Acoustic Pediatric Osteometer (APO). The proposed device will perform multiple diagnostic functions: assessment of bone mineralization and growth processes, and detection of tumor-like lesions in long bones of children and adolescents. By discrete sonication along a bone by linear array of probes, the APO will generate an ultrasound velocity profile of the examination cite, located in metaphyses near growth zones and in diaphyses. Probes for one- or two-way measurements will be applied to cites with thin (distal ulna, tibia) or thick (humerus, proximal femur) soft tissues layers, correspondingly. A versatile diagnostic potential of this approach was demonstrated in the preliminary clinical studies, that included detection of the mineralization lag in ulnar metaphyses during pubescence and growth spurt, identification of generalized mineral deficiency during chronic renal disorders, and detection of unicameral bone cysts in proximal humerus. The main objectives of Phase I are (1) to develop an APO prototype device with linear array probes, microprocessor measurement unit and PC interface; (2) to validate the diagnostic value of the device through model studies and to prepare for the clinical trials that will be performed further in Phase II.
The portable Acoustic Pediatric Osteometer (APO) is designed for screening and monitoring of bone mineralization quality during growth, pubescence and maturation, and for detection of osteopenia during chronic endocrine and metabolic diseases. This radiation-free device is a unique tool for the proposed application that also offers versatility, ease of operation, compactness, and low cost. There is a significant market potential for APO in response to growing concern for the developmental health.
