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在青少年特发性脊柱侧凸(AIS)后路脊柱融合术(PSF)中使用硅酸钙磷酸盐(SiCaP)作为骨移植替代物的手术结果。

Surgical results with the use of Silicated Calcium Phosphate (SiCaP) as bone graft substitute in Posterior Spinal Fusion (PSF) for Adolescent Idiopathic Scoliosis (AIS).

作者信息

Harshavardhana Nanjundappa S, Noordeen Mohammed H H

机构信息

Twin Cities Spine Center, 1111 S 8th St, Apt 214 N, Minneapolis, 55404 MN USA.

Spinal Deformity Unit, Royal National Orthopaedic Hospital NHS Trust, Brockley Hill-Stanmore, Middlesex HA7 4LP UK.

出版信息

Scoliosis. 2015 Aug 21;10:27. doi: 10.1186/s13013-015-0051-x. eCollection 2015.

Abstract

BACKGROUND

The gold standard iliac crest bone graft (ICBG) used to achieve arthrodesis in spinal fusions is not without complications (donor-site morbidity, iliac wing fractures etc.…). Our objectives were to evaluate the role of silicated calcium phosphate (SiCaP), an osteoconductive synthetic bone graft substitute in conjunction with locally harvested autologous bone in achieving arthrodesis following posterior spinal fusion (PSF) for adolescent idiopathic scoliosis (AIS) and report clinic-radiological results / adverse events with its use in a prospective single surgeon case series (Level of evidence [LoE] IV) treated by low implant density index (IDI) constructs (i.e., IDI ≤1.5).

METHODS

Thirty-five patients (8♂ & 2727♀) who underwent PSF and followed-up for a minimum of 2 years formed the study cohort. The mean age at surgery was 15 years (range: 11-21y) and pre-op Cobb angle was 60° (range: 40°-90°). SiCaP mixed with locally harvested bone during exposure and instrumentation was laid over instrumented segments. The average SiCaP used per patient was 32mls (range: 10-60mls). Radiographs were assessed for fusion at serial six monthly follow-ups. All clinical adverse events and complications were recorded.

RESULTS

The mean follow-up was 2.94 years (range: 2-4y). The post-op Cobb angle improved to 23° (range: 2°- 55°) and the mean in-patient stay was 7.72 days (range: 5-13d). The mean number of instrumented segments was 9.4 (range: 4-13) and implant density index (IDI) averaged 1.23 (range: 1.15-1.5). Radiographic new bone formation was seen within 3 months in all cases. All patients (except two) were highly satisfied at minimum follow-up of 8 years. There were two complications warranting revision surgery (deep infection, and implant failure without any evidence of pseudarthrosis). There were no SiCaP specific adverse events in any of the 35 patients.

CONCLUSION

SiCaP facilitated early bony consolidation in operated cohort of AIS patients treated by PSF. There were no inflammatory reaction or other adverse effects associated with its use. SiCaP is a safe alternative to autologous iliac crest bone graft with reduced complications, morbidity, faster recovery and similar infection/fusion rates reported in the literature.

摘要

背景

用于脊柱融合术中实现关节融合的金标准髂嵴骨移植(ICBG)并非没有并发症(供区并发症、髂骨翼骨折等)。我们的目的是评估硅酸钙磷酸盐(SiCaP),一种骨传导性合成骨移植替代物,与局部采集的自体骨联合使用,在青少年特发性脊柱侧凸(AIS)后路脊柱融合术(PSF)后实现关节融合的作用,并在一个前瞻性单术者病例系列(证据等级[LoE]IV)中报告其临床放射学结果/不良事件,该系列采用低植入密度指数(IDI)结构(即IDI≤1.5)进行治疗。

方法

35例接受PSF并至少随访2年的患者(8例男性和27例女性)组成研究队列。手术时的平均年龄为15岁(范围:11 - 21岁),术前Cobb角为60°(范围:40° - 90°)。在暴露和器械操作过程中,将SiCaP与局部采集的骨混合后铺在器械固定节段上。每位患者使用的SiCaP平均量为32毫升(范围:10 - 60毫升)。在每6个月的连续随访中通过X线片评估融合情况。记录所有临床不良事件和并发症。

结果

平均随访时间为2.94年(范围:2 - 4年)。术后Cobb角改善至23°(范围:2° - 55°),平均住院时间为7.72天(范围:5 - 13天)。器械固定节段的平均数量为9.4个(范围:4 - 13个),植入密度指数(IDI)平均为1.23(范围:1.15 - 1.5)。所有病例在3个月内均可见X线片上新骨形成。所有患者(除2例)在至少8年的随访中高度满意。有2例并发症需要翻修手术(深部感染和植入物失败,无任何假关节证据)。35例患者中均未出现与SiCaP相关的特定不良事件。

结论

SiCaP促进了PSF治疗的AIS患者手术队列中的早期骨融合。使用过程中未出现炎症反应或其他不良反应。SiCaP是自体髂嵴骨移植的一种安全替代物,并发症减少,发病率降低,恢复更快,且文献报道的感染/融合率相似。

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