PMID- 11211097 OWN - NLM STAT- MEDLINE DCOM- 20010607 LR - 20190921 IS - 0920-5063 (Print) IS - 0920-5063 (Linking) VI - 11 IP - 8 DP - 2000 TI - Clinical long-term in vivo evaluation of poly(L-lactic acid) porous conduits for peripheral nerve regeneration. PG - 869-78 AB - It was the purpose of this study to evaluate the clinical long-term effects of PLLA degradation in vivo on nerve regeneration in the rat sciatic nerve model. Thirty-one Sprague Dawley rats were utilized. Two groups of animals were selected. The control group of 10 animals received a 12 mm reversed isograft into the right sciatic nerve from 5 donor animals. The experimental group (n = 21) received a 12 mm empty PLLA conduits placed into a 12 mm defect in the right sciatic nerve. The left leg served as an internal control. Walking track analysis was performed monthly through 8 months. At the end of 4 and 8 months, animals in the control isograft and experimental group had the medial and lateral gastrocnemius muscles harvested and weighed for comparison. The midconduit/isograft and the distal nerve in these same animals were harvested and histomorphologically analyzed. Multiple samples were collected and expressed as means +/- standard error. A two-sample t-test and Wilcoxon rank sum test was used to compare the variables. Significance level was set at alpha = 0.05. After Bonferroni correction for multiple testing, a p value of < or = 0.01 was considered statistically significant. Throughout all time periods, the PLLA conduit remained structurally intact and demonstrated tissue incorporation and vascularization. There was no evidence of conduit collapse or breakage with limb ambulation. Moreover, there was no evidence of conduit elongation at 8 months as previously observed with the 75:25 poly(DL-lactic-co-glycolic acid) (PLGA) conduits. The mean absolute value of the sciatic functional index (SFI) demonstrated no group differences from isograft controls measured over the 8 months except at 3 months where the isograft values were higher (p = 0.0379) and at 7 months were the isograft group was significantly lower (p = 0.0115). At 4 and 8 months, the weight of the gastrocnemius muscles of the experimental group was not significantly different from isografts. At 4 months the number of axons/mm2 and nerve fiber density was not significantly different between the isograft control and experimental groups in either the midconduit/isograft or distal nerve. At 8 months the number of axons/mm2 was significantly lower in the isograft compared to the midconduit experimental group (p = 0.006). The number of axons/mm2 in the distal nerve and the nerve fiber density in the midconduit and distal nerve were not significantly different between the two groups. The study confirmed our initial hypothesis that PLLA conduits are a viable scaffold for clinical long-term nerve gap replacement. We are critically aware however that longer evaluation of polymer degradation is warrented. Further studies on these individual nerve components are continuing, with the ultimate goal being the fabrication of a bioactive conduit that meets or exceeds the functional results of isografts. FAU - Evans, G R AU - Evans GR AD - Department of Plastic Surgery, The University of Texas, M. D. Anderson Cancer Center, Houston 77030, USA. Gevans@notes.mdacc.tmc.edu FAU - Brandt, K AU - Brandt K FAU - Niederbichler, A D AU - Niederbichler AD FAU - Chauvin, P AU - Chauvin P FAU - Herrman, S AU - Herrman S FAU - Bogle, M AU - Bogle M FAU - Otta, L AU - Otta L FAU - Wang, B AU - Wang B FAU - Patrick, C W Jr AU - Patrick CW Jr LA - eng GR - CA-16672/CA/NCI NIH HHS/United States PT - Journal Article PT - Research Support, Non-U.S. Gov't PT - Research Support, U.S. Gov't, P.H.S. PL - England TA - J Biomater Sci Polym Ed JT - Journal of biomaterials science. Polymer edition JID - 9007393 RN - 0 (Membranes, Artificial) RN - 0 (Polyesters) RN - 0 (Polymers) RN - 33X04XA5AT (Lactic Acid) RN - 459TN2L5F5 (poly(lactide)) SB - IM MH - Animals MH - Axons/physiology MH - Lactic Acid/*chemistry/pharmacology MH - *Membranes, Artificial MH - Muscle, Skeletal/physiology MH - Nerve Fibers/physiology MH - Peripheral Nerves/*metabolism/*physiology MH - Polyesters MH - Polymers/*chemistry/pharmacology MH - *Prostheses and Implants MH - Rats MH - Rats, Sprague-Dawley MH - *Regeneration MH - Sciatic Nerve/chemistry MH - Time Factors MH - Walking EDAT- 2001/02/24 12:00 MHDA- 2001/06/08 10:01 CRDT- 2001/02/24 12:00 PHST- 2001/02/24 12:00 [pubmed] PHST- 2001/06/08 10:01 [medline] PHST- 2001/02/24 12:00 [entrez] AID - 10.1163/156856200744066 [doi] PST - ppublish SO - J Biomater Sci Polym Ed. 2000;11(8):869-78. doi: 10.1163/156856200744066.