72 - MIS Treatment of VCF, Prospective, Multi Center Clinical Study: Clinic...

#72 MIS Treatment of VCF, Prospective, Multi Center Clinical Study: Clinical Results, Complications

MIS Techniques and Outcomes

Poster Presented by: D.C. Noriega Gonzalez

Author(s):

D.C. Noriega Gonzalez (1)
A. Kruger (2)
F. Ardura (1)
F. Hassel (3)
N. Sans (4)
X. Barreau (5)
L. Galovich (6)

(1) Valladolid University, Orthopedic, Valladolid, Spain
(2) Marburg University, Trauma, Marburg, Germany
(3) Loreto Clinic, Neurosurgery, Fribourg, Germany
(4) Toulousse University, Orthopedic, Toulousse, France
(5) Bourdeax University, Neuroradiology, Bourdeaux, France
(6) Fundacion Jimenez Diaz, Orthopedic, Madrid, Spain

Abstract

Background: The purpose of this prospective, consecutive, multicentric observational study was to confirm the safety and clinical performance of the SpineJack® System in combination with Cohesion® Bone Cement (PMMA) for the treatment of vertebral compression fractures.

Methods: Thirty nine vertebral compression fractures in 32 patients were treated using the SpineJack® minimally invasive surgery protocol at seven different international sites. Patients with either osteoporotic or traumatic fractures were included. Outcome was determined by using the VAS for measuring pain, the Oswestry Disability Index for scoring functional capacity and the self-reporting system EQ-5D for the quality of life. Safety was evaluated by reporting all adverse events according to ISO 14155. The occurrence of cement leakages was assessed either by X-ray or CT scan, or both.

Results: Significant improvements were found regarding pain, function and quality of life at 6 and 12 months follow up. The cement leakage rate found is comparable with leakage rates published for balloon kyphoplasty. However also very complex fractures (A3) were included and the most precise analysis method available (CT-scan) was used unlike most studies published (X-ray). No device- or surgery-related complications were found.

Conclusions: This observational study demonstrates promising and persistent results consisting of sustained pain relief and durable clinical improvement after the procedure and throughout the 1 year follow up period. More importantly the majority of the patients went back to normal life as shown by significant changes in both EQ-5D and ODI. Randomized clinical trials are suggested to confirm these encouraging results.

Keywords: Vertebral Compression Fracture, minimal invasive, high-viscosity, PMMA bone cement.