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Preventing Post-Laminectomy Peridural Fibrosis

预防椎板切除术后硬膜外纤维化

基本信息

批准号：
7534544
负责人：
Weiliam Chen
金额：
$ 21.53万
依托单位：
ENDOMEDIX, INC.
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-09-01 至 2010-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7534544
关键词：
Adhesions Arachnoiditis Back Back Pain Biocompatible Characteristics Chitosan Cicatrix Degenerative Disorder Dextrans Diskectomy Drug Formulations Dura Mater Epidemic Event Fibrosis Future Goals Healed Hip region structure Hyaluronan Hydrogels In Situ In Vitro Laminectomy Leg Low Back Pain Magnetic Resonance Imaging Mechanics Modeling Nerve Nerve Endings Neurosurgical Procedures Operative Surgical Procedures Oryctolagus cuniculus Outcome Pain Patients Performance Phase Physicians Plant Roots Postoperative Period Procedures Process Property Public Health Rate Site Small Business Funding Mechanisms Small Business Innovation Research Grant Societies Staging System Thigh structure Tissues Translating United States Food and Drug Administration Validation Vertebral column Visit biomaterial compatibility cytotoxicity design dextran disability efficacy evaluation experience hazard healing in vivo perineural prevent seal spinal cord compression therapy design

项目摘要

DESCRIPTION (provided by applicant): Post-operative peridural fibrosis (scarring) is an associated event of lumbar microdiskectomy, and it significantly increases the hazard of revision spine surgery. The formation of scar tissue is part of the normal healing process and also an unavoidable consequence of procedures involving laminectomy. Epidural scar formation can result in fibrous adhesions around nerve roots imposing tension by entrapping the exiting nerve root resulting in mechanical tethering and eventually nerve damage; it can also cause compression of the spinal cord leading to subsequent pain. Dense adhesions and excessive scarring of the dura following lumbar surgery can cause radicular pain, low back pain, and even arachnoiditis. All these could result in the need for subsequent re-operation. The goal of this project is to develop a biocompatible and biodegradable in situ gelable hydrogel system to transiently seal the laminectomy site to prevent adhesion caused by excessive fibrotic tissue formation. The performance characteristics of the hydrogel formulations will initially be optimized; this is followed by validation of its biocompatibility. The project will be concluded after performing in vivo efficacy evaluations in rabbit laminectomy epidural fibrosis models. This Phase I SBIR project will set the stage for developing future treatment to greatly reduce the rate of revision surgery on procedures involving laminectomy. PUBLIC HEALTH RELEVANCE: Lumbar diskectomy has evolved as the most common neurosurgical procedure in the U.S., with nearly 300,000 procedures performed annually because of the epidemic problem of radicular leg and back pain, which translates into 15 million annual physician visits per year. It has been estimated that the financial burden on society exceeds $50 billion annually. The formation of scar tissue is part of the normal healing process and also an unavoidable consequence of procedures involving laminectomy Post-operative peridural fibrosis (scarring) is an associated event of lumbar microdiskectomy, and it significantly increases the hazard of revision spine surgery. Extensive epidural scar formation can result in fibrous adhesions around nerve roots imposing tension by entrapping the exiting nerve root resulting in mechanical tethering and eventually nerve damage; it can also cause compression of the spinal cord leading to subsequent pain. Dense adhesions and excessive scarring of the dura following lumbar surgery can cause radicular pain, low back pain, and even arachnoiditis. Current re-operation rates after lumbar microdiskectomy are estimated at 9-14%. Re-operation rates after decompressive surgery for degenerative conditions (laminectomy, diskectomy) has increased in patients treated in the early (1990-1993) versus late (1997-2000) 1990's, despite better treatment options. The goal of this project is to develop a biocompatible, bioresorbable and in situ gelable polymeric vehicle to be administered as a "post-laminectomy anti-adhesion therapy" designed to enhance the efficacy for microdiskectomy leading to decrease in the rate of re-operation.

描述（申请人提供）：术后硬膜外纤维化（疤痕）是腰椎微椎间盘切除术的相关事件，它显着增加了脊柱翻修手术的风险。疤痕组织的形成是正常愈合过程的一部分，也是涉及椎板切除术的手术不可避免的结果。硬膜外疤痕形成可导致神经根周围的纤维粘连，通过卡住退出的神经根施加张力，导致机械束缚并最终导致神经损伤；它还可能导致脊髓受压，导致随后的疼痛。腰椎手术后硬脑膜致密粘连和过度疤痕可引起神经根痛、腰痛，甚至蛛网膜炎。所有这些都可能导致需要随后重新手术。该项目的目标是开发一种生物相容性和可生物降解的原位凝胶水凝胶系统，以暂时密封椎板切除部位，以防止因过度纤维化组织形成而引起的粘连。水凝胶配方的性能特征将首先得到优化；随后验证其生物相容性。该项目将在兔椎板切除术硬膜外纤维化模型中进行体内疗效评估后结束。该第一期 SBIR 项目将为开发未来治疗方法奠定基础，以大大降低涉及椎板切除术的翻修手术率。公共健康相关性：腰椎间盘切除术已发展成为美国最常见的神经外科手术，由于神经根性腿部和背部疼痛的流行问题，每年进行近 300,000 例手术，这意味着每年有 1500 万人次就诊。据估计，每年给社会带来的经济负担超过500亿美元。疤痕组织的形成是正常愈合过程的一部分，也是涉及椎板切除术的手术不可避免的后果。术后硬膜外纤维化（疤痕）是腰椎微椎间盘切除术的相关事件，它显着增加了脊柱翻修手术的风险。广泛的硬膜外疤痕形成可导致神经根周围的纤维粘连，通过卡住退出的神经根施加张力，导致机械束缚并最终导致神经损伤；它还可能导致脊髓受压，导致随后的疼痛。腰椎手术后硬脑膜致密粘连和过度疤痕可引起神经根痛、腰痛，甚至蛛网膜炎。目前腰椎微椎间盘切除术后的再手术率估计为 9-14%。尽管有更好的治疗选择，但在 20 世纪 90 年代初期（1990-1993 年）接受退行性病变减压手术（椎板切除术、椎间盘切除术）的患者与晚期（1997-2000 年）相比，再次手术率有所增加。该项目的目标是开发一种生物相容性、可生物吸收和可原位凝胶的聚合物载体，作为“椎板切除术后抗粘连疗法”，旨在提高微椎间盘切除术的疗效，从而降低再次手术率。