Silicone-Based Bone Graft Promotes Improved Bone Formation

The Actifuse bone graft is based on silicate substituted calcium phosphate chemistry and provides surgeons with a safe and effective alternative to both autograft and allograft bone grafts. By using the innovative silicon substitution chemistry, bone formation is accelerated, and the subsequent organization and strength of the graft/host bone composite structure is greatly improved. Unlike traditional calcium phosphate-based or other silicon-containing products, the Actifuse bone graft is steadily and predictably remodeled by the host biology over time, ensuring that sufficient conductive scaffold remains for the duration of new bone growth and its subsequent maturation.

According to three new studies presented at the North American Spine Society (NASS; Burr Ridge, IL, USA) Spring break meeting, held during April 2009 in Rio Grande (Puerto Rico), the Actifuse has the potential to be as clinically effective as to the current "gold standard” therapy in the treatment of patients with degenerative lumbar spine disease, Iliac crest bone graft (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 preoperatively, as measured by the Visual Analogue Scale (VAS), with 95% of patients reporting satisfaction levels that were good or excellent. There were no incidences of infection, bone graft complications, or instrumentation failures. In a second study, 69 patients with degenerative lumbar spine disease--of which 45% had two levels fused, and 41% were fused at three or more levels--underwent a standard posterolateral spinal fusion using Actifuse. The results showed that 81% of the patients had radiographic evidence of bilateral bridging bone one year after surgery; 57% of the patients reported relief from back pain, and 67% reported relief of leg pain.

The Actifuse bone graft is a product of ApaTech (London, UK), and is available in a range of granule and microgranule formulations, as an advanced Bone matrix (Actifuse ABX), in a standard applicator, as a formable graft material (Actifuse Shape), and is also available in a granule applicator (Actifuse EasyPrep).

"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," said Simon Cartmell, CEO of ApaTech. "These data further demonstrate ApaTech's leadership in the science of silicon and the biostimulative effects of Actifuse."

Related Links:
North American Spine Society
ApaTech