Percutaneous Stabilization System Osseofix® for Treatment of Osteoporotic Vertebral Compression Fractures - Clinical and Radiological Results after 12 Months.

STUDY DESIGN: A prospective consecutive cohort study (follow-up study). OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.