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news.ApaTech, a developer of synthetic bone repair material, has presented new clinical data for its synthetic bone graft, Actifuse, suggesting that it can provide a preferable alternative to the current 'gold standard' therapy, Iliac Crest Bone Graft, or ICBG, in the treatment of patients with degenerative lumbar spine disease.
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According to ApaTech, the results from three new studies show that Actifuse has the potential to be as clinically effective as ICBG, without the problems associated with the latter.
The first study involved 38 patients with a diagnosis of lumbar stenosis, followed up two years after treatment with Actifuse as part of a standard lumbar fusion procedure. Fusion rates were graded at two years in excess of 81%. Results also showed a 68% decrease in pain experienced pre-operatively, as measured by the Visual Analogue Scale (VAS) (8.0 pre-operatively to 2.6 at two years), with 95% of patients reporting satisfaction levels that were good or excellent. There were no incidences of infection, bone graft complications or instrumentation failures, said ApaTech.
The second study involved 69 patients with degenerative lumbar spine disease, of which 45% had two levels fused, and 41% were fused at three or more levels. All patients underwent a standard posterolateral spinal fusion using Actifuse. Approximately 81% of patients had radiographic evidence of bilateral bridging bone one year after surgery and 57% of patients reported relief from back pain, and 67% reported relief of leg pain. The study authors concluded that Actifuse is an excellent alternative to ICBG for posterolateral spinal fusion in patients requiring surgical treatment for degenerative disease of the lumbar spine.
In a third study, rhBMP-2, a widely used biological treatment, was shown to be associated with double the levels of new leg pain compared to Actifuse following Minimally Invasive Transforaminal Lumbar Interbody Fusion (MITLIF), a standard procedure for spinal fusion.
Approximately, 483 patients undergoing single level MITLIF were assessed: 411 were given rhBMP-2 and 93 Actifuse. The incidence of new post-operative leg pain with rhBMP-2 is twice that seen with Actifuse. In addition, post-operative VAS scores for upper and lower leg pain at six to 12 weeks were significantly lower in patients given Actifuse, the company added.
Simon Cartmell, ApaTech’s CEO, said: “These results for Actifuse are very exciting. We are proud to provide a new option for physicians in the treatment of degenerative lumbar spine disease. These data further demonstrate ApaTech’s leadership in the science of silicon and the biostimulative effects of Actifuse.”