A pilot study to evaluate the effectiveness of small intestinal submucosa.pdf

The Spine Journal 2 (2002) 188–196 1529-9430/02/$ – see front matter ? 2002 Elsevier Science Inc. All rights reserved. PII: S1529-9430(02)00182-1 A pilot study to evaluate the effectiveness of small intestinal submucosa used to repair spinal ligaments in the goat Eric H. Ledet, MS a, *, Allen L. Carl, MD a , Darryl J. DiRisio, MD a , Michael P. Tymeson, MS a , Lucille B. Andersen, MD a , Christine E. Sheehan a , Bhaskar Kallakury, MD a , Michael Slivka, MS b , Hassan Serhan, PhD b a Albany Medical College, 47 New Scotland Avenue, Albany, NY 12208, USA b DePuy AcroMed, 325 Paramount Drive, Raynham, MA, 02767 USA Received 19 September 2001; accepted 27 February 2002 Abstract Background context: Destabilization of the lumbar spine results from sacrifice of the anterior lon- gitudinal ligament and disc when removed for graft or cage placement. In a similar fashion, transec- tion of the interspinous ligament during surgical approaches to the posterior spine may result in seg- mental instability. Such instability can cause abnormal motion or implant migration resulting in a higher incidence of pseudarthrosis. Small intestinal submucosa (SIS) is a naturally occurring extra- cellular collagen-based matrix, which is derived from porcine small intestine. SIS contains cytokines and growth factors and has been shown to act as a resorbable scaffold in vivo that promotes host soft tissue regeneration with little scar tissue formation. SIS can be manufactured in laminated sheets of various sizes and thicknesses for different indications. Successful applications of SIS in animals have included dural substitution, rotator cuff repair, vessel repair, abdominal and bladder wall re- pair, and others. However, SIS has not been investigated to determine its ability to facilitate regener- ation of spinal ligaments. Purpose: The purpose of this pilot study was to evaluate the efficacy of SIS as a barrier to prevent interbody