Fracture care using percutaneously applied titanium mesh cages (OsseoFix®) for unstable osteoporotic thoracolumbar burst fractures is able to reduce cement-associated complications--results after 12 months.

BACKGROUND: Despite the known demographic shift with expected doubled rate of vertebral body fractures by the year 2050, a standardized treatment concept for traumatic and osteoporotic incomplete burst fracture of the truncal spine does not exist. This study aims to determine whether minimally invasive fracture care for incomplete osteoporotic thoracolumbar burst fractures using intravertebral expandable titanium mesh cages is a suitable procedure and may provide improved safety in terms of cement-associated complications in comparison to kyphoplasty procedure. METHODS: In 2011/2012, 15 patients (10 women, 5 men; mean age 77) with 15 incomplete osteoporotic thoracolumbar burst fractures (T10 to L4) were stabilized using intravertebral expandable titanium mesh cages (OsseoFix®) as part of a prospective study. X-ray, MRI and bone density measurements (DXA) were performed preinterventionally. The clinical and radiological results were evaluated preoperatively, postoperatively and after 12 months according to the visual analogue scale (VAS), the Oswestry Disability Index (ODI), X-ray (Beck Index, Cobb angle) and CT analyses. Wilcoxon rank sum test, sign test and Fischer's exact test were used for statistical evaluation. RESULTS: A significant reduction in pain intensity (VAS) from preoperative 8.0 to 1.6 after 12 months and significant improvement in activity level (ODI) from preoperative 79.0 to 30.5 % after 12 months were revealed. Radiologically, the mean kyphotic angle according to Cobb showed significant improvements from preoperative 9.1° to 8.0° after 12 months. A vertebral body subsidence was revealed in only one case (6.7 %). No changes in the position of the posterior wall were revealed. No cement leakage or perioperative complications were seen. CONCLUSION: As a safe and effective procedure, the use of intravertebral expandable titanium mesh cages presents a valuable alternative to usual intravertebral stabilization procedures for incomplete osteoporotic burst fractures and bears the potential to reduce cement-associated complications. TRIAL REGISTRATION: German Clinical Trials Register (DKRS) DRKS00008833 .

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.