KIVA vertebral augmentation system lowers cement leakage

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Panagiotis Korovessis (Orthopaedic General Hospital “Agios Andreas”, Patras, Greece) reported the results of a study at EuroSpine (2–4 October, Liverpool, UK) that indicated the KIVA vertebral augmentation system was associated with a significantly lower rate of cement leakage than balloon kyphoplasty for the management of osteoporotic vertebral compression fractures. 

Korovessis commented that minimally invasive vertebral body augmentation should be considered if a patient with a osteoporotic vertebral  body fracture has persistent pain despite conservative treatment.  However, he added that cement leakage with the current methods of vertebral augmentation (eg. Kyphoplasty or vertebroplasty) remained a “relatively common problem.”  The KIVA vertebral augmentation device, according to Korovessis, is novel system that is designed to reconstruct the vertebral body with its PEEK implant and reduce cement leakage significantly. The aim of the present prospective randomised study was to compare sagittal vertebral height restoration and in wedge deformity restoration efficacy and cement leakage safety with the KIVA system with that of balloon kyphoplasty.


Patients were included in the study if they had acute back pain without trauma or without recent low-energy trauma, had their pain for less than three months’ duration, and had evidence of one or more vertebral compression fracture. Of 168 eligible patients in the study, 82 (with 133 fractures between them) received treatment with the KIVA device and 86 patients (with 122 fractures between them) received treatment with balloon kyphoplasty.


At the average 14 month follow-up point, both treatments significantly restored anterior, posterior, and midline vertebral body height. However, only the KIVA system was found to have significantly reduced wedge angle (p=0.002). Korovessis said: “Residual kyphosis of more than five degrees was measured significantly more frequently in the balloon kyphoplasty spines than in the KIVA spines (p<0.001).”


Cement leakage with the KIVA system (3%) was significantly less than with balloon kyphoplasty (9.8%; p<0.05 for the comparison). “Intracranal leakage in two patients with balloon kyphoplasty developed acute neurologic impairment (resulting in an emergency decompression).” No intracanal cement leakage  occurred with the KIVA system. The functional outcome  including   VAS (back pain)  scores and Oswestry Disability Index scores improved significantly with both treatments.

 

There were no significant differences between the treatments in the rate of new fractures.


The presenter concluded: “KIVA seems to be an alternative to balloon kyphoplasty with several advantages mostly regarding cement leakage and vertebral wedge deformity reduction.”