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Marquette University

Biomedical Engineering Faculty Research and Publications

2019

DIAM®; efficacy; safety; clinical trial; explant study; polymeric wear debris; host response; foreign body reaction; histology; Oil Red O

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An Evaluation Of The Host Response To An Interspinous Process Device Based On A Series Of Spine Explants: Device For Intervertebral Assisted Motion (Diam®), Jeffrey M. Toth, Justin D. Bric Dec 2019

An Evaluation Of The Host Response To An Interspinous Process Device Based On A Series Of Spine Explants: Device For Intervertebral Assisted Motion (Diam®), Jeffrey M. Toth, Justin D. Bric

Biomedical Engineering Faculty Research and Publications

Background:

The objective of this study was to evaluate the host response to an interspinous process device [Device for Intervertebral Assisted Motion (DIAM®)] based on a series of nine spine explants with a mean post-operative explant time of 35 months.

Methods:

Explanted periprosthetic tissues were processed for histology and stained with H&E, Wright-Giemsa stain, and Oil Red O. Brightfield and polarized light microscopy were used to evaluate the host response to the device and the resultant particulate debris. The host response was graded per ASTM F981-04. Quantitative histomorphometry was used to characterize particle size, shape, and area per ASTM F1877-05. …