Ender Stephan Albrecht, Wetterau Elmar, Ender Michaela, Kühn Jens-Peter, Merk Harry Rudolf, Kayser Ralph
Department of Orthopaedics and Orthopaedic Surgery, University Medicine Greifswald, Greifswald, Germany.
PLoS One. 2013 Jun 26;8(6):e65119. doi: 10.1371/journal.pone.0065119. Print 2013.
A prospective consecutive cohort study (follow-up study).
Our study investigated whether implantation of an expandable titanium mesh cage (Osseofix®) is a successful and safe minimally invasive therapy for osteoporotic vertebral compression fractures (VCF). Our experiences, clinical and radiological findings after 12 months follow-up are presented. Kypho- and vertebroplasty are well-established minimally invasive procedures for the treatment of osteoporotic VCF. The main complications associated with both procedures are uncontrolled bone cement leakage. Therefore a suitable alternative has been investigated.
During June 2010 to May 2011 24 patients were included with 32 osteoporotic VCF (T6 to L4). All of them were stabilized with the Osseofix® system. Preinterventionally we performed X-ray, MRI, and bone density measurements (DXA). Clinical and radiological results were evaluated preop., postop. and after 12 months postop. based on the Oswestry Disability Index (ODI) and the Visual Analogue Scale (VAS), X-ray (Beck Index, Cobb-angle) and CT.
There was a significant improvement in the mean ODI (70,6% to 30,1%) as well as a significant reduction in pain intensity (VAS) (7,7 to 1,4) after 12 month. The mean kyphotic angle according to Cobb showed significant improvements (11,7° to 10,4°) after 12 months. Postinterventional imaging showed only one case of loss of height in a stabilized vertebral body (3.1%). We saw no changes in posterior vertebral wall or adjacent fractures. Except for one pronounced postoperative hematoma we saw no surgical complications including no cement leakage.
Stabilization of symptomatic osteoporotic VCF with Osseofix® system is a safe and effective procedure, even in fractures with posterior wall involvement. The clinical mid-term results are good at a very low complication rate. The Osseofix® system is an interesting alternative to the established procedures of cement augmentation.
前瞻性连续队列研究（随访研究）。
我们的研究调查了可扩张钛网笼（Osseofix®）植入术对于骨质疏松性椎体压缩骨折（VCF）是否是一种成功且安全的微创治疗方法。本文介绍了我们在12个月随访后的经验、临床及影像学结果。后凸成形术和椎体成形术是治疗骨质疏松性VCF的成熟微创手术。与这两种手术相关的主要并发症是骨水泥渗漏失控。因此，人们一直在研究合适的替代方法。
在2010年6月至2011年5月期间，纳入了24例患有32处骨质疏松性VCF（T6至L4）的患者。所有患者均采用Osseofix®系统进行固定。干预前，我们进行了X线、MRI和骨密度测量（DXA）。基于Oswestry功能障碍指数（ODI）、视觉模拟量表（VAS）、X线（贝克指数、Cobb角）和CT，对术前、术后及术后12个月的临床和影像学结果进行评估。
12个月后，平均ODI有显著改善（从70.6%降至30.1%），疼痛强度（VAS）也显著降低（从7.7降至1.4）。根据Cobb法测量的平均后凸角在12个月后有显著改善（从11.7°降至10.4°）。干预后的影像学检查显示，在一个稳定的椎体中仅有1例高度丢失（3.1%）。我们未发现椎体后壁或相邻骨折有变化。除了1例明显的术后血肿外，我们未发现手术并发症，包括无骨水泥渗漏。
使用Osseofix®系统稳定有症状的骨质疏松性VCF是一种安全有效的方法，即使是累及后壁的骨折。临床中期结果良好，并发症发生率极低。Osseofix®系统是已有的骨水泥强化手术的一种有趣替代方法。
