Cortical Bone Mechanics Technology™ is a Paradigm Shift
Measuring in vivo mechanics of bone rather than bone mineral density
Developing CBMT will shift the paradigm of clinical bone research and (later) clinical practice for bone disease from bone mineral to bone mechanics by enabling the mechanical properties of cortical bone to be measured in vivo. This non-invasive, non-significant risk device will enable investigators to characterize the distribution of cortical bone mass, stiffness, damping, and strength in the human population, and to study the effects of various diseases and interventions on these properties.
Depending on the outcome of that research and the development and subsequent FDA approval of a medical device, CBMT may also enable physicians to better identify which patients to treat to prevent low-trauma fractures. That, in turn, may greatly reduce the cost and hazard of unnecessary preventive care as well as the cost, pain and disability resulting from fractures in patients who do not currently receive needed preventive care.
CBMT Improvements over Previous MRTA Technology
MRTA (Mechanical Response Tissue Analysis) and CBM (Cortical Bone Mechanics™) data are highly sensitive to the precise location over a bone where the data are collected. The key obstacles to reliable MRTA measurements were the wide individual variations in the external form of bones and in the chaotic internal osteoporotic destruction of cortical bone tissue. These factors make it impossible for the operator of an MRTA device to recognize where to collect valid data, or whether collected data are valid. CBMT ensures that valid data are collected by (a) rapidly collecting many data sets at closely spaced locations, and (b) using novel, patent-pending algorithms to recognize distinctive features of valid data in real time.
AEIOU’s CBMT is the closest in vivo predictor of true bone stiffness
Bone strength cannot be measured directly, because you have to break a bone to know how strong it was. It has been known for 40 years that measurements of bone stiffness accurately predict bone strength, but the first step in the Gold Standard method for measuring bone stiffness and strength (Quasistatic Mechanical Testing, QMT) is to remove the bone from the body.
Cortical Bone Mechanics Technology™ (CBMT) is a non-significant risk, non-invasive, radiation-free vibration analysis technique for making direct, functional measurements of cortical bone stiffness and, thereby, accurate estimates of cortical bone strength. CBMT does this at the mid-shaft of the ulna bone on the little finger side of the forearm. An oscillatory force similar that of an electric razor or toothbrush is applied to the skin over the ulna and the resulting mechanical vibration is analyzed. Using a proof-of-concept manually operated CBMT device, our pre-clinical study of 35 cadaveric human arms from men and women ranging widely in age (17-99 yrs) and body mass index (13-40 kg/m2) found CBMT and QMT measurements of ulna bending stiffness and estimates of ulna bending strength were statistically indistinguishable
Scientific Premise. One reason BMD does not identify which particular patients need medical care to prevent low-trauma fractures is that after age 60 most bone loss is cortical and most fractures occur at non-spine, non-hip sites of predominantly cortical bone. Hence, a new diagnostic technique is needed to assess the strength of cortical bone.
The least ambiguous place to assess cortical bone is at the mid-shaft of long bones, where there is no true trabecular bone to confound the assessment, but where accumulating resorption spaces progressively reduce the cortex to geometrically chaotic and structurally incompetent “trabecularized” cortical bone. The best method for assessing the mechanics of the mid-shaft of a long bone is a mechanical bending test, and the human bone most ideally suited for a bending test in vivo is the ulna bone in the forearm, due to the nature of its articulation with the humerus. The Gold Standard method for measuring bone mechanics is quasi-static mechanical testing (QMT), but QMT can only test bones that have been removed from the body.
The CBMT system applies oscillatory forces to the skin overlying the mid-shaft of the ulna bone in the human forearm and measures the resulting vibration acceleration to estimate the bending stiffness, damping, mass, flexural rigidity and bending strength of the ulna bone for scientific research purposes only. The system is not a medical device and is not intended to be used in the diagnosis, monitoring, prevention, or treatment of disease.