Institute of Biomedical Engineering, College of Engineering & College of Medicine, National Taiwan University, Taipei, Taiwan.
Spine (Phila Pa 1976). 2010 May 1;35(10):E385-91. doi: 10.1097/BRS.0b013e3181c9f7fc.
An in vivo clinical trial, and an in vitro cadaveric biomechanical and micromorphologic analysis.
To find the feasibility of using viscoplastic bone cement for vertebroplasty.
Vertebroplasty involved in bone cement reinforcement of fractured vertebra has shown promising clinical results. The most frequently observed complication of vertebroplasty is the cement leakage during surgery. Many methods were proposed and were successful at reducing the risk of leakage, such as creating a void within vertebra to reduce the injection pressure, increasing the cement viscosity to reduce the cement infiltration, etc. Nevertheless, a more cost-effective and safer surgery method is still the goal for many spine surgeons and researchers.
To deliver the viscoplastic bone cement into the vertebra, a unipedicular tract and a void in the vertebra was created using a curette. The viscoplastic bone cement was then delivered into the void piece by piece and tamped for compactness with a blunt end tool. For the in vitro biomechanical test, 7 thoracic vertebrae were used. The intact specimens were compressed to lose 25% of its intact height, and then augmented with viscoplastic bone cement. Postaugmentation CT scanning was taken to examine the cement distribution, leakage path, and cement filling ratio within the vertebra. Postaugmentation compression test was conducted to examine the vertebral strength and stiffness, and then compared with the intact ones. Finally, the vertebrae were cut into slices for micromorphologic analysis.
The 6 in vivo clinical trials were all successfully operated with significant pain relief and showed no leakage during and after the surgery. The in vitro biomechanical test showed the cement augmentation significantly increased the vertebral strength (pre 3164 (229) N vs. post 3905 (484) N, P < 0.003), but tentatively decreased the vertebral stiffness (pre 1074 (74) N/mm vs. post 801 (370) N/mm, P = 0.081). The postaugmentation CT scanning showed the cement was well confined within the vertebra and the cement filling ratio was 21% (ranged from 15% to 29%). The depth that the viscoplastic bone cement infiltrated into the cancellous bone was 3.5 (0.6) mm, which is less than the depth [8.3 (2.2) mm, P < 0.001] of standard viscous bone cement vertebroplasty.
Vertebroplasty using viscoplastic bone cement is clinically feasible and can effectively improve the vertebral strength and reduce the cement infiltration depth. The risk of cement leakage can also be decreased by using viscoplastic bone cement.
一项体内临床试验和一项体外尸体生物力学及微观形态分析。
探讨可注射粘弹性骨水泥在椎体成形术中应用的可行性。
椎体成形术涉及对骨折椎体的骨水泥强化，已显示出有前景的临床结果。椎体成形术中最常见的并发症是手术过程中的骨水泥渗漏。为降低渗漏风险，提出了许多方法并取得了成功，例如在椎体内创建一个空隙以降低注射压力，增加骨水泥粘度以减少骨水泥渗透等。然而，对于许多脊柱外科医生和研究人员来说，一种更具成本效益和更安全的手术方法仍是目标。
使用刮匙在椎体内创建单皮质通道和一个空洞，将可注射粘弹性骨水泥逐块注入空洞并使用钝端工具夯实。为了进行体外生物力学测试，使用了 7 个胸椎体。完整标本被压缩至失去其完整高度的 25%，然后用可注射粘弹性骨水泥增强。增强后进行 CT 扫描，检查骨水泥在椎体内的分布、渗漏途径和填充率。增强后进行压缩试验，以评估椎体强度和刚度，并与完整椎体进行比较。最后，将椎体切成薄片进行微观形态分析。
6 例体内临床试验均成功实施，术后疼痛明显缓解，术中及术后无骨水泥渗漏。体外生物力学测试显示，骨水泥增强显著增加了椎体强度（术前 3164（229）N 比术后 3905（484）N，P < 0.003），但暂时降低了椎体刚度（术前 1074（74）N/mm 比术后 801（370）N/mm，P = 0.081）。增强后 CT 扫描显示骨水泥在椎体内得到良好的限制，骨水泥填充率为 21%（15%~29%）。可注射粘弹性骨水泥渗透到松质骨的深度为 3.5（0.6）mm，小于标准粘性骨水泥椎体成形术的渗透深度[8.3（2.2）mm，P < 0.001]。
使用可注射粘弹性骨水泥进行椎体成形术在临床上是可行的，可有效提高椎体强度，降低骨水泥渗透深度。使用可注射粘弹性骨水泥还可以降低骨水泥渗漏的风险。
