High Lumbar Spinal Fusion Rates Using Cellular Bone Allograft Irrespective of Surgical Approach.

IF 1.7 Q2 SURGERY International Journal of Spine Surgery Pub Date : 2024-09-12 DOI:10.14444/8612

Todd Lansford, Daniel K Park, Joshua J Wind, Pierce Nunley, Timothy A Peppers, Anthony Russo, Hamid Hassanzadeh, Jonathan Sembrano, Jung Yoo, Jonathan Sales

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Abstract

Background: Mounting evidence demonstrates a promising safety and efficacy profile for spinal fusion procedures using cellular bone allograft (CBA). However, limited data exists on fusion outcomes stratified by surgical approach. The current study investigates the effectiveness of CBA in lumbar spinal fusion by surgical approach (ie, anterior, lateral, and posterior approaches).

Methods: Patients undergoing lumbar spinal fusion with CBA (Trinity Elite) were enrolled into a prospective, multi-center, open-label clinical study (NCT02969616). Fusion status was assessed by an independent review of dynamic radiographs and computed tomography images. Clinical outcome measures included quality of life (QoL; EQ5D), disability (Oswestry Disability Index [ODI]), and pain (visual analog scale [VAS]) for back pain and leg pain). Patient data extending to 24 months were analyzed in a post-hoc analysis.

Results: A total of 252 patients underwent interbody fusion (159 women; 93 men). Patients had a mean age of 58.3 years (SD 12.5), height of 168.3 cm (SD 10.2), and weight of 87.3 kg (SD 20.0) with a body mass index of 30.8 kg/m² (SD 6.5). At 12 months, the overall fusion success rate for bridging bone was 98.5%; fusion success was 98.1%, 100.0%, and 97.9% for anterior, lateral, and posterior approaches, respectively. At 24 months, the overall fusion success rate for bridging bone was 98.9%; fusion success was 97.9%, 100.0%, and 98.8% for anterior, lateral, and posterior approaches, respectively. The surgical approach did not significantly impact fusion success. A significant (P < 0.0001) improvement in QoL, pain, and disability scores was also observed. Significant differences in the ODI, VAS, and EQ5D were observed between the treatment groups (P < 0.05).

Conclusions: CBA represents an attractive alternative to autograft alone, reporting a high rate of successful fusion and clinical outcomes across various surgical approaches.

Clinical relevance: The use of CBA for spinal fusion procedures, regardless of surgical approach, provides high rates of fusion with a favorable safety profile and improved patient outcomes.

Level of evidence: 4:

Trial registration: NCT02969616.

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使用细胞骨异体移植的腰椎融合率高，与手术方法无关

背景：越来越多的证据表明，使用细胞骨异体移植（CBA）进行脊柱融合手术具有良好的安全性和有效性。然而，按手术方法分层的融合效果数据有限。本研究按手术方式（即前路、侧路和后路）调查了细胞骨异体移植在腰椎融合术中的有效性：一项前瞻性、多中心、开放标签临床研究（NCT02969616）招募了接受CBA（Trinity Elite）腰椎融合术的患者。融合状态由动态X光片和计算机断层扫描图像的独立审查进行评估。临床结果指标包括生活质量（QoL；EQ5D）、残疾（Oswestry残疾指数[ODI]）和疼痛（腰痛和腿痛的视觉模拟量表[VAS]）。在一项事后分析中，对患者长达 24 个月的数据进行了分析：共有 252 名患者接受了椎间融合术（女性 159 人；男性 93 人）。患者的平均年龄为 58.3 岁（SD 12.5），身高为 168.3 厘米（SD 10.2），体重为 87.3 千克（SD 20.0），体重指数为 30.8 千克/平方米（SD 6.5）。12个月时，桥接骨的总体融合成功率为98.5%；前路、侧路和后路的融合成功率分别为98.1%、100.0%和97.9%。24 个月时，桥接骨的总体融合成功率为 98.9%；前路、侧路和后路的融合成功率分别为 97.9%、100.0% 和 98.8%。手术方式对融合成功率没有明显影响。患者的生活质量、疼痛和残疾评分也有明显改善（P < 0.0001）。治疗组之间在ODI、VAS和EQ5D方面存在显著差异（P < 0.05）：结论：CBA是一种有吸引力的替代自体移植物的方法，在各种手术方法中都有较高的融合成功率和临床疗效：临床相关性：在脊柱融合术中使用CBA，无论采用哪种手术方法，都能获得较高的融合成功率，同时具有良好的安全性，并能改善患者预后：4：试验注册：NCT02969616。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Spine Surgery Medicine-Surgery

CiteScore

3.10

自引率

0.00%

发文量

162

期刊介绍： The International Journal of Spine Surgery is the official scientific journal of ISASS, the International Intradiscal Therapy Society, the Pittsburgh Spine Summit, and the Büttner-Janz Spinefoundation, and is an official partner of the Southern Neurosurgical Society. The goal of the International Journal of Spine Surgery is to promote and disseminate online the most up-to-date scientific and clinical research into innovations in motion preservation and new spinal surgery technology, including basic science, biologics, and tissue engineering. The Journal is dedicated to educating spine surgeons worldwide by reporting on the scientific basis, indications, surgical techniques, complications, outcomes, and follow-up data for promising spinal procedures.