Applications of a New Handheld Reference Point Indentation Instrument Measuring Bone Material Strength.
Abstract: A novel, hand-held Reference Point Indentation (RPI) instrument, measures how well the bone of living patients and large animals resists indentation. The results presented here are reported in terms of Bone Material Strength, which is a normalized measure of how well the bone resists indentation, and is inversely related to the indentation distance into the bone. We present examples of the instrument's use in: (1) laboratory experiments on bone, including experiments through a layer of soft tissue, (2) three human clinical trials, two ongoing in Barcelona and at the Mayo Clinic, and one completed in Portland, OR, and (3) two ongoing horse clinical trials, one at Purdue University and another at Alamo Pintado Stables in California. The instrument is capable of measuring consistent values when testing through soft tissue such as skin and periosteum, and does so handheld, an improvement over previous Reference Point Indentation instruments. Measurements conducted on horses showed reproducible results when testing the horse through tissue or on bare bone. In the human clinical trials, reasonable and consistent values were obtained, suggesting the Osteoprobe is capable of measuring Bone Material Strength in vivo, but larger studies are needed to determine the efficacy of the instrument's use in medical diagnosis.
Publication Date: 2013-09-24 PubMed ID: 24115973PubMed Central: PMC3792445DOI: 10.1115/1.4024829Google Scholar: Lookup
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Summary
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This research article introduces a new handheld instrument called the Reference Point Indentation (RPI) tool, which is designed to measure the material strength of bone in living patients and animals. The tool has been tested in laboratory scenarios, human clinical trials, and equine trials to assess its efficacy, demonstrating positive results in terms of consistency and reliability.
Overview of the Handheld RPI Instrument
- The handheld RPI instrument represents an innovative way to measure the strength of bone material, expressed through a normalized metric known as Bone Material Strength (BMS). BMS defines how well a bone resists indentation – the lower the indentation, the higher the strength of the bone material.
- The unique aspect of this tool is its handheld design, making it more practical and versatile than previous RPI instruments.
- The research paper presents tests carried out in laboratory conditions, human clinical trials, and horse clinical trials.
Laboratory Experiments
- In laboratory conditions, the tool was tested on bone samples. Some of these tests also involved having to measure through layers of soft tissue.
- The RPI tool produced consistent results, showing that it can effectively determine BMS even when the measurement is made through layers of soft tissue such as skin and periosteum.
Human Clinical Trials
- Three human clinical trials have been done or are ongoing at Barcelona, Mayo Clinic, and Portland, OR. The consistency of the instrument’s results across these trials suggests its reliability.
- Although the results are promising, the authors of the study indicate the need for larger studies to determine the instrument’s effectiveness in medical diagnosis.
Horse Clinical Trials
- The horse clinical trials at Purdue University and Alamo Pintado Stables in California also yielded reliable and reproducible results.
- This is an important aspect, demonstrating the tool’s applicability not just in human but also in veterinary medicine.
- The tests successfully measured BMS both through tissue and on bare bone, showing the instrument’s versatility.
Cite This Article
APA
Randall C, Bridges D, Guerri R, Nogues X, Puig L, Torres E, Mellibovsky L, Hoffseth K, Stalbaum T, Srikanth A, Weaver JC, Rosen S, Barnard H, Brimer D, Proctor A, Candy J, Saldana C, Chandrasekar S, Lescun T, Nielson CM, Orwoll E, Herthel D, Kopeikin H, Yang HT, Farr JN, McCready L, Khosla S, Diez-Perez A, Hansma PK.
(2013).
Applications of a New Handheld Reference Point Indentation Instrument Measuring Bone Material Strength.
J Med Device, 7(4), 410051-410056.
https://doi.org/10.1115/1.4024829 Publication
Researcher Affiliations
Grant Funding
- R01 GM065354 / NIGMS NIH HHS
- UL1 RR024150 / NCRR NIH HHS
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