背景:大量证据表明,使用细胞同种异体骨移植(CBA)进行脊柱融合手术具有良好的安全性和有效性。然而,根据手术入路分层的融合结局数据有限.本研究调查了CBA在通过手术方法进行腰椎融合中的有效性(即,前,横向,和后路)。
方法:接受CBA(TrinityElite)腰椎融合术的患者被纳入前瞻性研究,多中心,开放标签临床研究(NCT02969616)。通过对动态X射线照片和计算机断层扫描图像的独立审查来评估融合状态。临床结局指标包括生活质量(QoL;EQ5D),残疾(Oswestry残疾指数[ODI]),和疼痛(背部疼痛和腿部疼痛的视觉模拟量表[VAS])。在事后分析中分析了延长至24个月的患者数据。
结果:共有252名患者接受了椎间融合术(159名女性;93名男性)。患者的平均年龄为58.3岁(SD12.5),高度168.3厘米(SD10.2),体重87.3kg(SD20.0),体重指数30.8kg/m2(SD6.5)。12个月时,桥接骨的整体融合成功率为98.5%;融合成功率为98.1%,100.0%,前部为97.9%,横向,和后路,分别。24个月时,桥接骨的整体融合成功率为98.9%;融合成功率为97.9%,100.0%,前牙占98.8%,横向,和后路,分别。手术方法对融合成功没有显着影响。QoL显著(P<0.0001)改善,疼痛,并且还观察到残疾评分.ODI的显著差异,VAS,治疗组间EQ5D比较差异有统计学意义(P<0.05)。
结论:CBA代表了单独自体移植的一种有吸引力的替代方案,报告各种手术入路的融合成功率和临床结局都很高。
结论:CBA用于脊柱融合术,不管手术方法如何,提供了高融合率和良好的安全性,并改善了患者的预后。
方法:
背景:NCT02969616。
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.
CONCLUSIONS: 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.
METHODS: BACKGROUND: NCT02969616.