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具有独特表面形貌的双相磷酸钙骨移植材料:一项针对腰椎退行性疾病的单中心双盲研究。

Biphasic Calcium Phosphate Bone Graft With a Unique Surface Topography: A Single-Center Ambispective Study for Degenerative Disease of the Lumbar Spine.

作者信息

Nunley Pierce, Sanda Milo, Googe Henry, Cavanaugh David, Sage Katherine, Ryaby James, Stone Marcus B

机构信息

Spine Surgery, Spine Institute of Louisiana, Shreveport, USA.

Spine, Spine Institute of Louisiana, Shreveport, USA.

出版信息

Cureus. 2024 Apr 13;16(4):e58218. doi: 10.7759/cureus.58218. eCollection 2024 Apr.

Abstract

STUDY DESIGN

This study is an ambispective evaluation and analysis of a single-center cohort.

OBJECTIVE

This study aimed to evaluate the performance of a novel biphasic calcium phosphate (BCP) bone graft with submicron-sized needle-shaped surface topography (BCP<µm) in interbody arthrodesis of the lumbar spine.

METHODS

This study was a single-center ambispective assessment of adult patients receiving BCP<µm as part of their lumbar interbody fusion surgery. The primary outcome was a fusion status on computed tomography (CT) 12 months postoperative. The secondary outcomes included postoperative changes in the visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form 12 (SF-12), and length of stay (LOS).

RESULTS

Sixty-three patients with one- to three-level anterior (48, 76%) and lateral (15, 24%) interbody fusions with posterior instrumentation were analyzed. Thirty-one participants (49%) had three or more comorbidities, including heart disease (43 participants, 68%), obesity (31 participants, 49%), and previous lumbar surgery (23 participants, 37%). The mean ODI decreased by 24. The mean SF-12 physical health and SF-12 mental health improved by a mean of 11.5 and 6.3, respectively. The mean VAS for the left leg, right leg, and back improved by a mean of 25.75, 22.07, and 37.87, respectively. Of 101 levels, 91 (90%) demonstrated complete bridging trabecular bone fusion with no evidence of supplemental fixation failure.

CONCLUSION

The data of BCP<µm in interbody fusions for degenerative disease of the lumbar spine provides evidence of fusion in a complicated cohort of patients.

摘要

研究设计

本研究是对单中心队列进行的回顾性和前瞻性评估与分析。

目的

本研究旨在评估一种具有亚微米级针状表面形貌的新型双相磷酸钙(BCP)骨移植材料(BCP<µm)在腰椎椎间融合术中的性能。

方法

本研究是对接受BCP<µm作为腰椎椎间融合手术一部分的成年患者进行的单中心回顾性和前瞻性评估。主要结局是术后12个月计算机断层扫描(CT)上的融合状态。次要结局包括术后视觉模拟量表(VAS)、Oswestry功能障碍指数(ODI)、简短健康调查简表(SF - 12)的变化以及住院时间(LOS)。

结果

分析了63例接受一至三级前路(48例,76%)和侧路(15例,24%)椎间融合并后路内固定的患者。31名参与者(49%)有三种或更多合并症,包括心脏病(43名参与者,68%)、肥胖症(31名参与者,49%)和既往腰椎手术史(23名参与者,37%)。平均ODI下降了24。平均SF - 12身体健康和SF - 12心理健康分别平均改善了11.5和6.3。左腿、右腿和背部的平均VAS分别平均改善了25.75、22.07和37.87。在101个节段中,91个(90%)显示出完全的桥接小梁骨融合,且无补充固定失败的证据。

结论

BCP<µm用于腰椎退行性疾病椎间融合的数据为复杂患者队列中的融合提供了证据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63c2/11091845/f0496fa2cb96/cureus-0016-00000058218-i01.jpg

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