An injectable nucleus replacement as an adjunct to microdiscectomy: 2 year follow-up in a pilot clinical study
An injectable nucleus replacement as an adjunct to microdiscectomy: 2 year follow-up in a pilot clinical study
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DOI：
10.1007/s00586-009-1136-0
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发表时间：
2009-11-01
影响因子：
2.8
通讯作者：
Schwarzenbach, Othmar
中科院分区：
文献类型：
--
作者：
Berlemann, Ulrich;Schwarzenbach, Othmar
文献表明，椎间盘突出和/或手术导致的椎间盘组织丢失可加速椎间盘退变。相关的椎间盘高度丢失可能与复发性背痛和/或腿痛相对应。已经开发了一种新型水凝胶来替代丢失的髓核，并可能在突出和手术后恢复正常的椎间盘生物力学。进行单中心、非随机、前瞻性可行性研究以研究NuCore（A（R））可注射Nucleus水凝胶（Spine Wave，Inc.，谢尔顿，CT，美国）作为因疝和显微椎间盘切除术而丢失的核组织的替代物。14例患者在作者所在医院入组，作为全球多中心初步研究的初始研究中心。入组研究的受试者因单节段髓核突出而发生神经根性疼痛，对保守治疗无反应。在标准的显微椎间盘切除术后，将水凝胶材料注入核空隙中，以替换因疝和手术而丢失的组织。术前和术后2年监测腿部和背部疼痛、功能和残疾评分。还进行了神经和身体评估，血液和血清分析，以及椎间盘高度和植入物稳定性的影像学评估。结果显示，腿部和背部疼痛以及功能评分有显着改善。未观察到并发症或器械相关不良事件。MR对照证实植入物位置稳定，无再疝。影像学测量结果表明，与单纯显微椎间盘切除术的文献数据相比，椎间盘高度的保持更好。NuCore（A（R））材料似乎可以保护椎间盘免受显微椎间盘切除术后的早期塌陷;因此，随着时间的推移，可能有可能减缓脊柱节段的退行性级联反应。
Literature indicates that loss of disc tissue from herniation and/or surgery can accelerate degeneration of the disc. The associated loss of disc height may correspond with recurrent back and/or leg pain. A novel hydrogel has been developed to replace lost nucleus pulposus and potentially restore normal disc biomechanics following herniation and surgery. A single-center, non-randomized, prospective feasibility study was undertaken to investigate the use of NuCore(A (R)) Injectable Nucleus hydrogel (Spine Wave, Inc., Shelton, CT, USA) as a replacement for nuclear tissue lost to herniation and microdiscectomy. Fourteen patients were enrolled at the authors' hospital as the initial site in a worldwide multicenter pilot study. Subjects who were entered into the study suffered from radicular pain due to single-level herniated nucleus pulposus and were non-respondent to conservative therapy. Following a standard microdiscectomy procedure, the hydrogel material was injected into the nuclear void to replace what tissue had been lost to the herniation and surgery. Leg and back pain, function and disability scores were monitored pre- and post-operatively through 2 years. Neurologic and physical evaluations, blood and serum analyses, and radiographic evaluations of disc height and implant stability were also performed. Results showed significant improvement for leg and back pain, as well as function scores. No complications or device related adverse events were observed. MR controls confirmed stable position of the implants with no reherniations. Radiographic measurements indicated better maintenance of disc height compared to literature data on microdiscectomy alone. The NuCore(A (R)) material appears to protect the disc from early collapse following microdiscectomy; and therefore, may have the potential to slow the degenerative cascade of the spinal segment over time.