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单独使用冻干同种异体骨或联合自体骨治疗脊椎椎间盘炎:一项随机双盲试验。

Spondylodiscitis treated with freeze-dried bone allograft alone or combined with autograft: A randomized and blinded trial.

作者信息

Martínez-Gutiérrez Oscar, Peña-Martínez Victor, Camacho-Ortiz Adrián, Vilchez-Cavazos Felix, Simental-Mendía Mario, Tamez-Mata Yadira, Acosta-Olivo Carlos

机构信息

27771Universidad Autónoma de Nuevo León, Facultad de Medicina, Hospital Universitario "Dr. José E. González", Monterrey, Nuevo León, Mexico.

出版信息

J Orthop Surg (Hong Kong). 2021 May-Aug;29(2):23094990211019101. doi: 10.1177/23094990211019101.

DOI:10.1177/23094990211019101
PMID:34041968
Abstract

PURPOSE

To compare the bone fusion of freeze-dried allograft alone versus freeze-dried allograft combined autograft in spinal instrumentation due to spondylodiscitis.

METHODS

A randomized prospective trial of patients with spondylodiscitis treated with surgical debridement and spinal fixation with freeze-dried bone allograft and autograft (Group 1) or freeze-dried bone allograft alone (Group 2) was performed. Patient follow-up was assessed with a CT-scan for bone fusion; consecutive serum inflammatory marker detection (C-reactive protein, [CRP], and erythrocyte sedimentation rate, [ESR]) and clinical assessment (pain, functional disability, and spinal cord injury recovery) were other outcome parameters. The primary outcome was the grade of bone allograft integration with the scale of Tan (which ranges from 1 to 4, with lower scores indicating a better fusion rate) at 1 year after surgery.

RESULTS

A total of 20 patients were evaluated, 13 (65%) men and 7 (35%) women with a mean age of 47.2 (±14.3) years. Homogeneous distribution of demographic data was observed. A similar satisfactory bone graft fusion grade was observed in both graft groups at 1 year after surgery (p = 1.0000). Serum inflammatory markers gradually decreased in both groups after surgical intervention (CRP, p < 0.001; ESR, p < 0.01). At one-year follow-up, gradual improvement of pain, functional disability, and neurological spinal injury recovery in both graft groups were achieved.

CONCLUSION

Freeze-dried allograft alone could be a therapeutic option for spinal fixation surgery due to spondylodiscitis since it achieves a satisfactory graft fusion rate and clinical improvement.

LEVEL OF EVIDENCE

Level 1. Treatment.

REGISTER

NCT03265561.

摘要

目的

比较单纯冻干同种异体骨与冻干同种异体骨联合自体骨在因脊椎椎间盘炎行脊柱内固定术中的骨融合情况。

方法

对因脊椎椎间盘炎接受手术清创及使用冻干同种异体骨和自体骨(第1组)或单纯冻干同种异体骨(第2组)进行脊柱固定治疗的患者进行了一项随机前瞻性试验。通过CT扫描评估患者的骨融合情况以进行随访;连续检测血清炎症标志物(C反应蛋白,[CRP],和红细胞沉降率,[ESR])以及临床评估(疼痛、功能障碍和脊髓损伤恢复情况)为其他结局参数。主要结局是术后1年时根据Tan分级(范围为1至4,分数越低表明融合率越好)评估的同种异体骨融合等级。

结果

共评估了20例患者,其中男性13例(65%),女性7例(35%),平均年龄47.2(±14.3)岁。观察到人口统计学数据分布均匀。术后1年时,两组植骨均观察到相似的满意骨移植融合等级(p = 1.0000)。手术干预后两组血清炎症标志物均逐渐下降(CRP,p < 0.001;ESR,p < 0.01)。在1年随访时,两组植骨患者的疼痛、功能障碍及脊髓神经损伤恢复情况均逐渐改善。

结论

单纯冻干同种异体骨可作为因脊椎椎间盘炎行脊柱固定手术的一种治疗选择,因为它能达到满意的植骨融合率并实现临床改善。

证据级别

1级。治疗。

注册信息

NCT03265561。

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