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FDA Compliance

NIST Measuring Device Aims to Up Hip Operation Success

Published: Tuesday, June 26, 2007 - 22:00

 
(NIST:Gaithersburg, Maryland) -- Researchers at the National Institute of Standards and Technology are developing state-of-the-art measuring techniques, similar to those used in making aerospace components fit together precisely, that soon could improve success rates for hip replacement surgery. At the request of a group of prominent orthopaedic surgeons and the American Academy of Orthopaedic Surgeons, the NIST researchers are working to improve calibrations and operating room testing of the computer-assisted orthopaedic surgery (CAOS) tracking instruments surgeons use to plan the delicate, highly complex operation. To be completely successful, CAOS hip replacement surgery must take into account tiny human skeletal differences. Imprecise measurements, which could result from conditions seemingly unrelated to the surgery, such as operation room noise or temperature, can lead to poor positioning of implants, leaving some patients with discomfort during walking and, in rarer cases, a need to redo the operation.

The researchers have built a lightweight device called “phantom” that resembles the artificial socket, ball, and femur substitutes that surgeons use to replace the joint and bone in hip operations, based on a calibrated X-Y coordinate frame. They drilled tiny holes at precisely measured intervals into the phantom and made cuts at precisely measured angles, favored by surgeons for CAOS operations. Because the precise coordinates of the mechanical (magnetic) ball and socket joint center of rotation have been measured, manufacturers of CAOS tracking sensors can use the phantom to test the accuracy of their measuring instruments. Surgeons also should be able to test the accuracy of their CAOS devices to measure ball and socket joint center of rotation coordinates, angles for cuts into the bone and places for the insertion of screws.

Currently, no standardized approach to the evaluation of CAOS technology exists, but an ASTM International committee is working on the establishment of such standards. In the coming months, NIST will submit its hip CAOS phantom to orthopaedic surgeons for review. Clinical trials could follow. If the device wins Federal Drug Administration approval, it’s expected to find its way into operating rooms across the country and world.

Researchers look forward to extending the application of the technology to surgical procedures on the knee and shoulder.

For more information, visit www.nist.gov/public_affairs/techbeat/tb2007_0426.htm#hip


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