Abstract Archives of the RSNA, 2011
Thomas Josef Vogl MD, PhD, Presenter: Nothing to Disclose
Johannes E. G. Hierholzer MD, Abstract Co-Author: Nothing to Disclose
Robert Pflugmacher, Abstract Co-Author: Nothing to Disclose
Matthew J. Gounis PhD, Abstract Co-Author: Research Consultant, Johnson & Johnson
Research Consultant, Micrus Corp
Research grant, Stryker Corporation
Research grant, Johnson & Johnson
Research grant, Surpass Medical Ltd
Research grant, Covidien AG
Research grant, Concentric Medical, Inc
Research grant, sanofi-aventis Group
Research grant, Neuravi Limited
Research grant, Neurointerventional Therapeutics, Inc
Research grant, Thrombolytic Science LLC
Ajay Kumar Wakhloo MD, PhD, Abstract Co-Author: Research Consultant, Johnson & Johnson
Research grant,Johnson & Johnson
Stockholder, Surpass Medical Ltd
Research Consultant, Koninklijke Philips Electronics NV
Research grant, Koninklijke Philips Electronics NV
Research Consultant, Boston Scientific Corporation
Research grant, Boston Scientific Corporation
Research Consultant, Soteira, Inc
Research grant Covidien
Research Consultant, Covidien
Christian Fiebig, Abstract Co-Author: Nothing to Disclose
Renate Maria Hammerstingl MD, Abstract Co-Author: Nothing to Disclose
A cement-directed kyphoplasty system (CDKS) was developed to provide directional control of cement flow during treatment of vertebral compression fractures. The goal of the procedure is to deliver cement into the anterior region of the vertebral body (VB), extending across the sagittal midline and towards the endplates. Posterior flow is minimized to reduce the risk of leakage into the venous system and spinal canal
A randomized (2:1) controlled study was performed comparing CDKS and bipedicular vertebroplasty (PVP). The CDKS procedure used a unipedicular approach with a combined curved drill and reamer to create a cylindrical cavity. The cement directing implant was inserted in a collapsed state, self-expanding to conform to the cavity. Cement was injected into the cement director, which guided flow into the anterior cancellous bone and restricted cement flow from the posterior VB. A total of 49 patients (65 levels) were treated with CDKS and 28 patients (39 levels) with PVP. Pain was assessed post-op, at 3 and 12 mos. using a 10-point visual analog scale (VAS). Vertebral body height was also compared at post-op and 3 mos. Radiographic and CT images taken at 3 mos. and 12 mos. were examined for adjacent level fractures.
Pain relief was equivalent for both treatment groups. A significant decrease in VAS scores was measured at post-op for both groups and pain relief was sustained throughout the follow-up period (p<0.001 for all comparisons). The mean change in VB height between post-op and 3 mos. was -4.00% (±8.52) and -9.42% (±8.28) for CDKS and PVP, respectively. Two adjacent level fractures were noted in the CDKS group (3.1%) and 3 were found in the PVP group (7.9%). None of the adjacent level fractures were related to endplate leaks.
CDKS provides control of cement placement and delivery, directing cement flow anteriorly and towards the superior and inferior endplates. Pain relief is equivalent to PVP. The procedure does not compromise the endplates or influence adjacent level fracture rates. The cement director limits posterior cement flow, reducing the risk of complications due to cement leakage.
CDKS provides effective pain relief for vertebral compression fractures. The resulting endplate-to-endplate cement distribution maintains VB height without affecting adjacent level fracture rates.
Vogl, T,
Hierholzer, J,
Pflugmacher, R,
Gounis, M,
Wakhloo, A,
Fiebig, C,
Hammerstingl, R,
Clinical Evaluation of Cement-directed Kyphoplasty System: Multicenter Trial. Radiological Society of North America 2011 Scientific Assembly and Annual Meeting, November 26 - December 2, 2011 ,Chicago IL.
http://archive.rsna.org/2011/11011195.html