This project verifies the effectiveness of a cartilage stiffness tester through a series of in vitro and in situ experiments. Utilizing non-destructive indentation, the proposed device will provide a rapid, accurate value for cartilage stiffness, which can then be correlated to its health. Our long-range goal is to commercially produce a clinical instrument for measuring articular cartilage stiffness. In this proposal, the objective is to test normal and degenerated cartilage and correlate it to traditional techniques for evaluating cartilage. This innovative project will complete the requisite work to show the utility of the instrument for detecting degenerative cartilage changes in human joints. Specific clinical indications include routine measuring of cartilage stiffness over time, early determination of cartilage disorders, and assessing outcomes from surgical operations. In Phase I, an integrated series of bench and animal studies will determine whether the instrument is sensitive enough to detect early degenerative cartilage changes, if it is dependent on cartilage thickness, and compare it to magnetic resonance imaging. Phase II will utilize the stiffness tester for in vivo human testing and establishment of a clinical database, for developing sterilization, and for finalizing instrument design. Large-scale manufacture will be optimized and marketing plans will be completed in Phase III.

Proposed Commercial Applications

No clinical instrument is available to quantify a loss in biomechanical properties of articular cartilage, which is one of the first signs of disease. The proposed non-destructive tester can measure cartilage stiffness to detect early degeneration allowing earlier intervention. Benefits of the device include quantifying cartilage degeneration, tracking of cartilage stiffness over time, and determining the extent of cartilage lesions. This instrument could be used in every arthroscopy to provide significant additional clinical information.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43AR047478-01
Application #
6292901
Study Section
Special Emphasis Panel (ZRG1-SSS-5 (05))
Program Officer
Lester, Gayle E
Project Start
2001-04-01
Project End
2001-09-30
Budget Start
2001-04-01
Budget End
2001-09-30
Support Year
1
Fiscal Year
2001
Total Cost
$100,006
Indirect Cost
Name
Osteobiologics, Inc.
Department
Type
DUNS #
City
San Antonio
State
TX
Country
United States
Zip Code
78249
Niederauer, Gabriele G; Niederauer, George M; Cullen Jr, Larry C et al. (2004) Correlation of cartilage stiffness to thickness and level of degeneration using a handheld indentation probe. Ann Biomed Eng 32:352-9