Osseofix® System for Percutaneous Stabilization of Osteoporotic and Tumorous Vertebral Compression Fractures – Clinical and Radiological Results After 12 Months

Abstract

Purpose: Determining whether implantation of an expandable titanium mesh cage (Osseofix? system) is a successful and safe minimally invasive therapy for osteoporotic and tumorous vertebral compression fractures (VCFs). Materials and Methods: 32 patients (25 women, 7 men, mean age 71) with 46 osteoporotic or tumorous VCFs (T6 to L4) from June 2010 to January 2012 were included. All of them were stabilized with the Osseofix? system. Preinterventionally we performed X-ray, MRI, and bone density measurements (DXA). The clinical and radiological results were evaluated preop, postop and 12 months postop based on the visual analog scale (VAS) and the Oswestry Disability Index (ODI), X-ray (Beck Index, Cobb angle) and CT. Results: There was a significant improvement in pain intensity (VAS) (7.8 to 1.6) as well as a?significant reduction in the mean ODI (71.36?% to 30.4?%) after 12 months. The mean kyphotic angle according to Cobb showed significant improvements (12.3? to 10.8?) after 12 months. Postinterventional imaging showed one case of loss of height in a stabilized lumbar vertebral body (2.2?%) in osteoporosis and one case with adjacent fracture (2.2?%) in osteoporosis. We saw no changes in the posterior vertebral wall. Except for one pronounced postoperative hematoma, we saw no surgical complications including no cement leakage. Conclusion: The clinical mid-term results are good at a low complication rate. The stabilization of symptomatic osteoporotic and tumorous VCFs with the Osseofix? system is a safe and effective procedure, even in fractures with posterior wall involvement. The Osseofix? system is an interesting alternative to the established procedures of cement augmentation. Key Points: ??The Osseofix? system is well suited for stabilizing osteoporotic and tumorous VCFs. ??It is a safe and effective procedure without cement leakage and with a low complication rate. ??The procedure is an interesting alternative to established cement augmentation procedures. Citation Format: ??Ender SA, Gradl G, Ender M et?al. Osseofix? System for Percutaneous Stabilization of Osteoporotic and Tumorous Vertebral Compression Fractures ? Clinical and Radiological Results After 12 Months. Fortschr R?ntgenstr 2014; 186: 380???387

Innovative Spine Implants for Improved Augmentation and Stability in Neoplastic Vertebral Compression Fracture

“…Among them, eight patients with tumorous VCF were implanted with Osseofix ® under general anaesthesia with uniplanar fluoroscopic guidance and were followed for 12 months (Table 1). Results after 12 months showed a significant pain relief (VAS = –6.5 points), significant function improvement (ODI score = –40.7%), and significant kyphotic angle long-lasting improvement without perioperative or postoperative complications linked to the device or the procedure in this subgroup of patients [23]. Other studies performed on osteoporotic VCF patients report comparable pain, function, and radiological results [23,24,25].…”

“…In 2014, Ender et al, published a prospective study aiming at establishing the usefulness of Osseofix ® to stabilize VCF in 32 patients [23]. Among them, eight patients with tumorous VCF were implanted with Osseofix ® under general anaesthesia with uniplanar fluoroscopic guidance and were followed for 12 months (Table 1).…”

The use of cone beam CT in achieving unipedicular spinal augmentation

“…They offer immediate relief of pain, mobility and in the case of kyphoplasty and stentoplasty, height restoration and kyphosis angle correction, achieved through percutaneous incisions. 2,3,6 Traditionally, SAPs were performed with the bipedicular approach achieved with the cannulation of both pedicles.…”

“…Percutaneous spinal augmentation procedures (SAP) are increasingly used for the treatment of patients with vertebral body fractures whom have failed conservative management. [1][2][3] Techniques include vertebroplasty, balloon kyphoplasty and stentoplasty, and needle trajectory planning and deployment were traditionally performed using fluoroscopy.…”

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

“…Vertebral body stabilization using the titanium mesh cages in the previously described manner was carried out in all cases [ 29 ]. At present, solitary use of the intravertebral expandable titanium mesh cages (OsseoFix®) using only bone cement is authorized.…”