Devoted to diagnostic and interventional spine imaging and therapeutics


A Novel Technique Employing Local Anesthesia For Percutaneous Vertebral Reconstruction Of Fresh And Non-Fresh Compression Fractures Using The B-Twin Expandable Implant: A Preliminary Multi-Center Study On The First 60 Operations. 2004

Gepstein, Reuven, M.D.
David, Rami, M.D.
Mirovsky, Igaal, M.D.
Pekarsky, Ilya, M.D.
Boriani, Stefano, M.D.
Folman, Yoram, M.D.

The current study was intended to assess the efficacy of a novel vertebral body reconstruction device, the B-Twin VBR. 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 operations to carry the procedure.

Material and Methods:
An institutional review board approved level I randomized trial. The B-Twin VBR implant (Disc-o-tech Ltd., Israel) is a titanium tube that following axial pressure applied using a specifically designed delivery system, radially expands by projecting fins toward the upper and lower endplates, causing their jacking up 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. Twenty patients (mean age 61.8) participated in the study. 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, one month, three months and in three month increments later on.

The preoperative average vertebral body compression height (A/P%) was 61.6%(±16%) of the pre-fracture height, improving to 79.1%(±14%) post-op. Average kyphosis angle decreased from 15.10 to 8.90. All patients reported significant pain relief; VAS scores ha d decreased from 8.3 to 2.2. Other than clinically insignificant minor cement extravasations in four patients, no complications occurred in the series.

Kyphoplasty using the B-Twin VBR implant was found to be an effective and safe mode of treatment of vertebral compression fractures. 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 capable of correcting chronic fractures as well.