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A Novel Technique For Percutaneous Local Anesthesia Reconstruction Of Vertebral Fractures: A Preliminary Report On The First 20 Cases 2004

Gepstein, Reuven, M.D.

Purpose:
The current report is intended to describe the author's initial experience with a novel vertebral body reconstruction device named the SKy Bone Expander. The implant is percutaneously inserted through the pedicle(s) and remotely expanded within the vertebral body resulting in vertebral height augmentation and void creation. Bone cement is then injected into the created void through the implant core, encasing the implant and forging the reconstructed vertebra. The device permits radiologists experienced with spine procedures to carry the procedure.

Material and Methods:
The SKy Bone Expander system (Disc-o-tech Ltd., Israel) is a polymer tube that following axial p ressure applied using a specifically designed delivery system, radially expands, causing endplate jacking and hence reconstruction of the compression fracture. This concept enables percutaneous positioning of the implant in its reduced form through the pedicle under local or general anesthesia, thus promoting minimal invasiveness. When adequate endplate augmentation has been achieved the device is contracted and removed. Cement injection into the created void follows. Twenty patients (mean age 62.5) have been treated using this system. Acute fractures were treated using a unilateral approach and chronic fractures were treated using a bilateral approach. Post-operative clinical evaluations were performed one week and one month post-op.

Results:
The preoperative average vertebral body compression height (A/P%) was 58.0%(±18%) of the pre-fracture height, improving to 81.8%(±12%) post-op. Average kyphosis angle decreased from 17.20 to 8.150. All patients reported signific ant pain relief. No complications occurred in the series.

Conclusion:
Kyphoplasty using the SKy Bone Expander system was found to be an effective and safe mode of treatment of vertebral compression fractures at the author's hands. The device enables maximal control of the expansion stage and location, and is far more rapid to deploy than other comparable methods currently available. Additionally, a unilateral approach in the treatment of acute fractures proved to achieve adequate cement void permeation. It has also been found that the implant is exceptionally capable of correcting chronic fractures as well.