Sebastian Arjun S, Wanderman Nathan R, Currier Bradford L, Pichelmann Mark A, Treder Vickie M, Fogelson Jeremy L, Clarke Michelle J, Nassr Ahmad N
Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN, USA.
Asian Spine J. 2019 Mar 15;13(4):544-555. doi: 10.31616/asj.2018.0277. Print 2019 Aug.
Prospective observational cohort study.
This study aims to evaluate the safety and efficacy of bone morphogenetic protein-2 (BMP-2) in transforaminal lumbar interbody fusion (TLIF) with regard to postoperative radiculitis.
Bone morphogenetic protein (BMP) is being used increasingly as an alternative to iliac crest autograft in spinal arthrodesis. Recently, the use of BMP in TLIF has been examined, but concerns exist that the placement of BMP close to the nerve roots may cause postoperative radiculitis. Furthermore, prospective studies regarding the use of BMP in TLIF are lacking.
This prospective study included 77 patients. The use of BMP-2 was determined individually, and demographic and operative characteristics were recorded. Leg pain was assessed using the Visual Analog Scale (VAS) for pain and the Sciatica Bothersome Index (SBI) with several secondary outcome measures. The outcome data were collected at each follow-up visit.
Among the 77 patients, 29 were administered with BMP. Postoperative leg pain significantly improved according to VAS leg and SBI scores for the entire cohort, and no clinically significant differences were observed between the BMP and control groups. The VAS back, Oswestry Disability Index, and Short-Form 36 scores also significantly improved. A significantly increased 6-month fusion rate was noted in the BMP group (82.8% vs. 55.3%), but no significant differences in fusion rate were observed at the 12- and 24-month follow-up. Heterotopic ossification was observed in seven patients: six patients and one patient in the BMP and control groups, respectively (20.7% vs. 2.1%). However, no clinical effect was observed.
In this prospective observational trial, the use of BMP in TLIF did not lead to significant postoperative radiculitis, as measured by VAS leg and SBI scores. Back pain and other functional outcome scores also improved, and no differences existed between the BMP and control groups. The careful use of BMP in TLIF appears to be both safe and effective.
前瞻性观察队列研究。
本研究旨在评估骨形态发生蛋白-2（BMP-2）在经椎间孔腰椎椎间融合术（TLIF）中用于预防术后神经根炎的安全性和有效性。
骨形态发生蛋白（BMP）在脊柱融合术中越来越多地被用作髂嵴自体骨移植的替代物。最近，BMP在TLIF中的应用已得到研究，但有人担心BMP靠近神经根放置可能会导致术后神经根炎。此外，缺乏关于BMP在TLIF中应用的前瞻性研究。
这项前瞻性研究纳入了77例患者。BMP-2的使用是个体化决定的，并记录了人口统计学和手术特征。使用视觉模拟疼痛量表（VAS）和坐骨神经痛困扰指数（SBI）评估腿痛情况，并采用了多项次要结局指标。在每次随访时收集结局数据。
77例患者中，29例使用了BMP。根据整个队列的VAS腿痛评分和SBI评分，术后腿痛明显改善，BMP组和对照组之间未观察到临床显著差异。VAS背痛评分、Oswestry功能障碍指数和简明健康状况调查36项评分也显著改善。BMP组6个月时的融合率显著提高（82.8%对55.3%），但在12个月和24个月随访时融合率无显著差异。7例患者出现异位骨化：BMP组6例，对照组1例（20.7%对2.1%）。然而，未观察到临床影响。
在这项前瞻性观察试验中，根据VAS腿痛评分和SBI评分，TLIF中使用BMP未导致显著的术后神经根炎。背痛和其他功能结局评分也有所改善，BMP组和对照组之间无差异。在TLIF中谨慎使用BMP似乎既安全又有效。
