Transforaminal Lumbar Interbody Fusion With rhBMP-2 in Spinal Deformity, Spondylolisthesis, and Degenerative Disease-Part 2 BMP Dosage-Related Complications and Long-term Outcomes in 509 Patients

Transforaminal Lumbar Interbody Fusion With rhBMP-2 in Spinal Deformity, Spondylolisthesis, and Degenerative Disease-Part 2 BMP Dosage-Related Complications and Long-term Outcomes in 509 Patients
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DOI:
10.1097/brs.0b013e3182880298
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发表时间:
2013-06-01
期刊:
影响因子:
3
通讯作者:
McLemore, Ryan
McLemore, Ryan
中科院分区:
医学2区
文献类型:
--
作者:
Crandall, Dennis G.;Revella, Jan;McLemore, Ryan

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研究设计.前瞻性收集数据的回顾性审查。在没有行业资助的情况下,该研究评价了一个大型连续系列中与经椎间孔腰椎椎间融合术(TLIF)联合使用的超说明书骨形态发生蛋白(BMP)相关的短期和长期并发症。根据BMP剂量、融合长度、初次手术与翻修手术对并发症和结果进行分析。根据研究结果,提出了手术技术和BMP剂量的建议。TLIF中BMP的标签外使用虽然常见,但仅在使用各种技术、融合器类型和BMP剂量的小系列和病例报告中进行了研究。其中一些研究报告了最小的并发症。其他人报告了与BMP相关的问题,这导致了目前广泛使用TLIF与BMP的问题。对509例连续成人患者的872个椎间盘进行了rhBMP-2 TLIF,这些患者接受了开放性后路内固定融合术,并至少随访2年;诊断包括退行性疾病(179例)、脊椎滑脱(207例)、畸形(123例)。患者平均年龄为61岁:12%为吸烟者,41%接受了翻修手术。在1.7个节段进行了TLIF:单节段:229,双节段:201,3节段:74,4节段:5。局部自体移植物用于每个矩形融合器周围和后面的回填。使用不同剂量的椎间骨形态发生蛋白,平均每个椎间盘7.3 mg(范围:每个椎间盘2-12 mg)。在平均5年随访时,8例患者在TLIF节段发生假关节(8/872个椎间盘,0.92%)。血清肿(0.4%)和异位骨生长(0.6%)太罕见,与特定的BMP剂量。深部感染总体为2.6%(退行性组为1.7%)。未发生症状性骨质溶解或椎间融合器下沉。与术前相比,远期临床和功能结果有显著改善。采用BMP的TLIF术后5年随访(独立于行业)证实了短期和长期融合(初次和翻修)中关节固定术的有效性。大多数并发症发生在畸形患者中。BMP相关并发症(血清肿、异位骨)罕见。
Study Design. Retrospective review of prospectively collected data.Objective. Without industry funding, the study evaluated shortand long-term complications related to off-label bone morphogenetic protein (BMP) used with transforaminal lumbar interbody fusion (TLIF) from a large consecutive series. Complications and results were analyzed by BMP dose, fusion length, and primary versus revision surgery. Based on the results, surgical technique and BMP dose recommendations were proposed.Summary of Background Data. Off-label use of BMP in TLIF, although common, has only been studied in small series and case reports using various techniques, cage types, and doses of BMP. Several of these studies have reported minimal complications. Others report problems related to BMP, which has led to questions regarding current widespread use of TLIF with BMP.Method. TLIF with rhBMP-2 was performed at 872 discs in 509 consecutive adults who underwent open posterior instrumented fusion and had minimum 2-year follow-up; diagnoses included degenerative disease (179), spondylolisthesis (207), deformity (123). Patient age averaged 61 years: 12% were smokers and 41% had revision surgery. TLIF was performed at 1.7 levels: single level: 229, 2 levels: 201, 3 levels: 74, 4 levels: 5. Local autograft was used for backfill around and behind each rectangular cage. Varying doses of interbody BMP were used at an average 7.3 mg per disc (range: 2-12 mg per disc).Results. At 5 years average follow-up, 8 patients developed pseudoarthrosis at levels of TLIF (8 of 872 discs, 0.92%). Seroma (0.4%) and ectopic bone growth (0.6%) were too infrequent to be associated with a particular BMP dose. Deep infection was 2.6% overall (1.7% of the degenerative group). Symptomatic osteolysis or cage subsidence did not occur. Significant long-term improvement was noted in clinical and functional outcomes compared with preoperation.Conclusion. Five-year follow-up after TLIF with BMP, independent of industry, confirms effective arthrodesis in short and long fusions, both primary and revision. Most complications occurred in deformity patients. BMP-related complications (seroma, ectopic bone) were rare.