Orthopedic Clinic- Polyclinic, Via Murge 59/A, 70124 Bari, Italy.
Orthop Traumatol Surg Res. 2011 Dec;97(8):846-51. doi: 10.1016/j.otsr.2011.08.006. Epub 2011 Nov 18.
Kyphoplasty and percutaneous vertebroplasty are two effective procedures for osteoporotic vertebral compression fractures, but there have been few publications on their use in non-osteoporotic forms. B-Twin(®) vertebral body reconstruction is a new minimally invasive vertebral body reconstruction technique developed for non-osteoporotic vertebral compression fractures of the thoracolumbar junction and lumbar spine.
The present study describes this novel technique and assessed efficacy compared to a conservative method.
Inclusion criteria were: Magerl type A1.2 non-osteoporotic thoracolumbar or lumbar spinal compression fractures in patients aged over 18 years, free of neurologic compromise. Patients were randomized to management by corset (group 1) or by the B-Twin(®) spacer (group 2). Follow-up used a visual analog scale (VAS) to assess pain, the Oswestry Disability Index (ODI) and, on radiology, the vertebral (VK) and regional (RK) kyphosis angles and anterior and medial height indices at baseline, 3 months and 12 months.
Group 1 comprised 26 patients; group 2 comprised 24 patients, with 44 implants. In group 1, mean VK was 10.7° (± 1.73°) at baseline, 11.9° (± 1.56°) at 3 months and 12.3° (± 1.6°) at 12 months. Mean RK was respectively 9.7° (± 0.97°), 11.10° (± 1.07°) and 11.8° (± 1.27). Mean medial height (medial-to-posterior [MH/PH] height ratio was respectively 0.75 [±0.05], 0.70 [±0.06] and 0.65 [±0.04]). Mean anterior height (anterior-to-posterior [AH/PH] height ratio) was respectively 0.79 [± 0.06], 0.76 [± 0.05] and 0.73 [± 0.05]). Mean VAS score was respectively 8.6 (± 0.52), 3.8 (± 0.82) and 2.3 (± 0.83). In group 2, mean VK was 13.8° (± 0.47°) at baseline, 4.88° (± 0.65°) at 3 months and 4.88° (± 0.65°). Mean RK was respectively 9.82° (± 1.67°), 4.47° (± 0.86°) and 4.82° (± 0.98°). Mean MH/PH ratio was respectively 0.69 (± 0.05), 0.86 (± 0.03) and 0.86 (± 0.03). Mean AH/PH ratio was respectively 0.73 (± 0.04), 0.90 (± 0.03) and 0.90 (± 0.03). Mean VAS score was 8.88 (± 0.47) at baseline, 2 (± 1) at 1-day post-surgery, 1.71 (± 0.88) at 3 months and 1.12 (± 0.23) at 12 months. The increase in vertebral body height in patients managed by B-Twin(®) was maintained at 6 and 12 months (P<0.0001). The study showed better results with the vertebral spacer than on conservative treatment, with a 95% reduction in bed-rest: 4-6 weeks in the conservative group vs. 2-3 days in the surgical group.
The vertebral body reconstruction technique provided anatomic vertebral body reconstruction and quick return to household activity without resort to a corset. Deformity was durably reduced. At 12-month follow-up, pain reduction and stasis were achieved. The risk of injected cement leakage was slight.
球囊扩张椎体后凸成形术和经皮椎体成形术是治疗骨质疏松性椎体压缩性骨折的两种有效方法，但对于非骨质疏松性椎体压缩性骨折的应用鲜有报道。B-Twin（®）椎体重建是一种新型微创椎体重建技术，专为胸腰椎和腰椎非骨质疏松性椎体压缩性骨折而开发。
本研究介绍了这种新的技术，并评估了与保守方法相比的疗效。
纳入标准为：Magerl 型 A1.2 非骨质疏松性胸腰椎或腰椎脊柱压缩性骨折，年龄大于 18 岁，无神经功能障碍。患者随机分为支具治疗组（组 1）或 B-Twin（®）间隔物治疗组（组 2）。随访采用视觉模拟评分（VAS）评估疼痛，Oswestry 功能障碍指数（ODI），以及影像学上的椎体（VK）和区域（RK）后凸角，以及基线、3 个月和 12 个月时的前侧和内侧高度指数。
组 1包括 26 例患者，组 2包括 24 例患者，共植入 44 个植入物。组 1 中，VK 在基线时为 10.7°（±1.73°），3 个月时为 11.9°（±1.56°），12 个月时为 12.3°（±1.6°）。RK 平均值分别为 9.7°（±0.97°）、11.10°（±1.07°）和 11.8°（±1.27°）。内侧高度（内侧到后侧[MH/PH]高度比分别为 0.75 [±0.05]、0.70 [±0.06]和 0.65 [±0.04]）。前侧高度（前侧到后侧[AH/PH]高度比分别为 0.79 [±0.06]、0.76 [±0.05]和 0.73 [±0.05]）。VAS 评分平均值分别为 8.6（±0.52）、3.8（±0.82）和 2.3（±0.83）。在组 2 中，VK 在基线时为 13.8°（±0.47°），3 个月时为 4.88°（±0.65°），3 个月时为 4.88°（±0.65°）。RK 平均值分别为 9.82°（±1.67°）、4.47°（±0.86°）和 4.82°（±0.98°）。MH/PH 比值平均值分别为 0.69（±0.05）、0.86（±0.03）和 0.86（±0.03）。AH/PH 比值平均值分别为 0.73（±0.04）、0.90（±0.03）和 0.90（±0.03）。VAS 评分平均值分别为 8.88（±0.47）、2（±1）、3 个月时为 1.71（±0.88）和 12 个月时为 1.12（±0.23）。使用 B-Twin（®）治疗的患者的椎体高度增加在 6 个月和 12 个月时保持不变（P<0.0001）。与保守治疗相比，椎体间隔物治疗的结果更好，卧床休息减少了 95%：保守组为 4-6 周，手术组为 2-3 天。
椎体重建技术提供了解剖学上的椎体重建，并迅速恢复家庭活动，而无需使用支具。畸形得到持久减少。在 12 个月的随访中，疼痛减轻和淤血得到缓解。注入水泥的泄漏风险很小。
