New and improved vertebral augmentation system shows promise
MedWire News: A new percutaneous vertebral augmentation device has demonstrated significant improvements on existing treatments, according to preliminary clinical findings.
"Vertebral compression fractures are common injuries with an incidence of 1.4 million each year. Manifestations of fractured vertebrae include severe chronic back pain, disability, and reductions in quality of life as well as greater risk of future vertebral fracture," say Panagiotis Korovessis (General Hospital "Agios Andreas", Patras, Greece, and team.
Vertebral compression fractures caused by osteoporosis can currently be treated using minimally invasive vertebral augmentation techniques but cement leakage is a common problem.
Initial testing of the Kiva system (Benvenue Medical, Santa Clara, California, USA) suggests that this new procedure minimizes cement leakage to clinically insignificant levels.
"[The Kiva system] was designed to reduce and stabilize osteoporotic vertebral fractures by deploying a coiled PEEK [polyetheretherketone] implant which is then augmented with cement. This technique allows directional cement delivery, which helps to facilitate cement containment," write the researchers in the journal BMC Musculoskeletal Disorders.
The study, involved 26 patients, of mean age 74 years, with 42 identified vertebral fractures. The patients were evaluated before, and again 2 and 6 months after undergoing the Kiva system treatment at the patients' fracture sites, which were all located between T10 and S1. The majority of fractures were symptomatic osteoporotic fractures (n=34) that had occurred within the previous 3 months, the remainder were pathologic fractures, caused by myeloma or metastatis.
Back pain, reported by the patients on an 11-point scale, improved by 70%, from a mean of 8.0 points pretreatment to 3.0 points at 6 months. Back pain-specific disability was also self-reported by the patients using the Oswestry Disability Index and improved by 56%, from 64% pretreatment to 29% at 6 months.
Using computer tomography and radiographs, the researchers were able to assess the extent of postoperative cement extravasation and found a clinically insignificant level of cement leakage. They report two observed cases of cement leakage, but that these did not result in clinical sequelae. There were no cases of intra-operative hypotension, respiratory disturbance, neurological deterioration, infection, or death, and no evidence of implant migration, subsidence, or refracture.
The researchers describe their results as "encouraging," as, although the effectiveness of vertebral augmentation remains controversial, evidence from recent trials show positive results.
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By Chloe McIvor