Interventional Spine

Kent, B, Remley, MD

Paper/Non-Mentor

Purpose

Vertebral augmentation aims to eliminate pain and attempts to restore vertebral height. The StaXx® FX system represents a technological advancement in percutaneous augmentation, providing 1 mm incremental, direct vertical fracture reduction. The PEEK implant is secured by placement of adjacent bone cement. The purpose of this study is to determine the percentage of fracture reduction achieved with the StaXx® FX system during vertebral augmentation and to verify that pain is alleviated post-op.

Methods & Materials

A retrospective review of the initial 40 subjects (28 females, 11 males; mean age 78 years) undergoing vertebral augmentation with the StaXx® FX Structural Kyphoplasty System was performed to evaluate post-operative vertebral body height and pain relief. Using standing lateral radiographs, vertebral height is measured at anterior, central, and posterior points. Digitized films are measured by an independent source using validated software. Vertebral body height is reported as a percentage of the reference height (adjacent intact vertebral body). Patients verbally ranked their pain on a scale of 1(none) to 10 (intense).

Results

Independent film reviewers analyzed films sets for 24 levels in 21 patients. Pre-operatively, all fractures demonstrated at least 15% initial height loss, with a mean loss of 52%. Anteriorly, 83% (p<0.001) of the available lost height was restored. Centrally, 86% (p<0.003) of available lost height was restored. No device related neurological or pulmonary complications occurred. Pain significantly decreased (p<0.0001) from a pre-operative score of 9.0 to a post-operative score of 1.0.

Conclusion

The post-op results illustrate that vertical fracture reduction using the StaXx® FX System minimizes intraoperative loss of correction, which allows the device to be more effective at retaining the positional and procedural reduction. Percutaneous vertebral augmentation with PEEK wafers appears to demonstrates better height restoration to that obtained with published vertebroplasty (3-48%) or balloon kyphoplasty (3-49%) techniques. Pain reduction is also virtually immediate and comparable to these augmentation methods.

References/Financial Disclosures

Reference:

McKiernan F. Osteoporosis Int (2008). 19: pp 123-125.

Disclosures:

Research support has been recieved from Spine Wave, Inc.
Consultant: ArthorCare, Spine Wave Inc., Spineology