Department of Neurosurgery, Klinikum rechts der Isar, Technische Universität München, Ismaningerstrasse 22, Munich, Germany.
Acta Neurochir (Wien). 2010 May;152(5):835-43. doi: 10.1007/s00701-009-0583-z. Epub 2010 Jan 19.
The objective of the study was to generate prospective data to assess the clinical results after dynamic stabilization with the Cosmic system (Ulrich Medical).
Between April 2006 and December 2007, 103 consecutive patients were treated with Cosmic for painful degenerative segmental instability +/- spinal stenosis. The preoperative workup included radiological (MRI and myelography/CT) and clinical parameters (general/neurological examination, visual analogue scale (VAS), Oswestry disability index (ODI), SF-36, Karnofsky (KPS)). At pre-defined intervals (at discharge, 6 weeks, 3 months, 6 months, 12 months, and yearly) the patients were reevaluated (X-ray/flexion/extension, neurological status, VAS, ODI, SF-36, KPS, and patient satisfaction). Data were collected in a prospective observational design.
Data collection was completed in 100 of 103 operated patients (mean follow-up, 15 +/- 0.6 months). Dynamic stabilization was performed as first-tier surgery in 43 cases and as second-tier therapy in 60 cases. Additional decompression was performed in 83 cases. Dynamic stabilization led to significant reduction of back pain-related disability (ODI pre-op, 51 +/- 1%; post-op, 21 +/- 1%) and improvement of pain (VAS pre-op, 65 +/- 1; post-op, 21 +/- 2), mental/physical health (norm-based SF-36: mental pre-op, 44; post-op, 48; physical pre-op, 41; post-op, 46), and mobility (KPS pre-op, 70 +/- 1; post-op, 82 +/- 31). Early reoperation was necessary in 12 patients (n = 3 symptomatic misplaced screws, n = 8 CSF pseudocele, rebleeding, or impaired wound healing, n = 1 misjudged instability/stenosis in adjacent segment). Reoperations within the follow-up period were necessary in another 10 patients due to secondary screw loosening (n = 2), persistent stenosis/disk protrusion in an instrumented segment (n = 3), symptomatic degeneration of an adjacent segment (n = 6), or osteoporotic fracture of an adjacent vertebra (n = 1), respectively. Patient satisfaction rate was 91%.
Dynamic stabilization with Cosmic achieved significant improvement of pain, related disability, mental/physical health, and mobility, respectively, and a high rate of satisfied patients. A reoperation rate of 10% during follow-up seems relatively high at first glance. Comparable data, however, are scarce, and a prospective randomized trial (spondylodesis vs. dynamic stabilization) is warranted based on these results.
本研究旨在前瞻性评估宇宙系统（Ulrich Medical）动力稳定治疗的临床效果。
2006 年 4 月至 2007 年 12 月，对 103 例因疼痛性退行性节段性不稳定伴/不伴脊柱狭窄而接受 Cosmic 治疗的患者进行了前瞻性数据评估。术前评估包括影像学（MRI 和脊髓造影/CT）和临床参数（一般/神经检查、视觉模拟评分（VAS）、Oswestry 残疾指数（ODI）、SF-36、卡诺夫斯基（KPS））。在规定的时间间隔（出院时、6 周、3 个月、6 个月、12 个月和每年）对患者进行重新评估（X 射线/屈伸、神经状态、VAS、ODI、SF-36、KPS 和患者满意度）。数据采用前瞻性观察性设计收集。
103 例手术患者中，100 例（平均随访 15 +/- 0.6 个月）完成了数据收集。43 例患者行一期动力稳定治疗，60 例患者行二期治疗。83 例患者行额外减压治疗。动力稳定治疗显著降低了腰痛相关残疾（ODI 术前 51 +/- 1%，术后 21 +/- 1%）和疼痛（VAS 术前 65 +/- 1，术后 21 +/- 2），改善了精神/身体健康（基于标准的 SF-36：精神状态术前 44，术后 48；身体状态术前 41，术后 46）和活动能力（KPS 术前 70 +/- 1，术后 82 +/- 31）。12 例患者（3 例症状性螺钉位置不当、8 例 CSF 假性囊肿、再出血或伤口愈合不良、1 例相邻节段不稳定/狭窄判断错误）需要早期再次手术。在随访期间，另外 10 例患者需要再次手术，原因分别为：二期螺钉松动（2 例）、器械节段持续性狭窄/椎间盘突出（3 例）、相邻节段症状性退行性变（6 例）和相邻椎体骨质疏松性骨折（1 例）。患者满意度为 91%。
采用 Cosmic 行动力稳定治疗，可显著改善疼痛、相关残疾、精神/身体健康和活动能力，患者满意度较高。随访期间的再手术率为 10%，乍一看似乎相对较高。然而，可比数据稀缺，基于这些结果，有必要进行脊柱融合术与动力稳定治疗的前瞻性随机试验。
