Clinical Outcomes From Cementless Percutaneous Implantation Of OsseoFix For The Treatment Of Vertebral Compression Fractures
Presented at SMISS Annual Forum 2014
By Oscar Alves MD, PhD
With P. Santos MD, O. Gomes MD,
Disclosures: Oscar Alves MD, PhD B; Alphatec Spine. P. Santos MD None, O. Gomes MD None,
Vertebral compression fractures (VCFs) are the most common fractures in patients with osteoporosis. Trauma and tumor can also elicit VCFs. Standard interventional treatments include vertebroplasty and kyphoplasty, which relies on cement to provide stability and/or height to the vertebral body. However, cement-related complications, such as pulmonary embolism is common and potentially serious. More recently, a novel OsseoFix Spinal Fracture Reduction System has become available. It features a percutaneously implantable titantium scaffold that expands within the vertebral body
The aim of this study is to evaluate VCF fixation using OsseoFix without cement. We hypothesized that the titanium mesh scaffold without cement can adequately restore height and stability lost in VCFs, translating to good clinical outcomes.
13 patients (5 males and 8 females, mean age 63.5) diagnosed with VCFs were included in this study. Osteoporosis, trauma and tumor were concomitant with VCFs in 7, 3 and 3 patients, respectively. A total of 28 vertebrae were treated, with one implant in 6 vertebrae and two implants in 22 vertebrae. VAS and ODI were recorded pre-operatively and at 3-month and 6-month follow-ups.
All 50 implants were optimally positioned and deployed without any complication. Clinical outcomes were statistically and functionally significant with pre-operative ODI score of 54.3±3.0 reducing to 11.9±3.0 and 10.5±1.0 at 3-month and 6-month follow-ups. Pre-operative VAS score of 8.0±0.8 improved to 1.5±0.8 and 1.1±0.3 at 3-month and 6-month follow-ups.
Percutaneous implantation of OsseoFix to treat VCFs provides good clinical outcomes. OsseoFix implantation offers an effective alternative to vertebroplasty or kyphoplasty, eliminating any cement-related complications. This study prompts additional studies with longer follow-ups for this novel cement-free vertebral stent as a potential next-generation treatment of VCFs.