While the mean follow-up time for collection of radiological data was 24 months, evidence of fusion was demonstrated as early as 3-6 months post-surgery in some patients (43% of one-level, 44% of 2-level). The one-level fusion rate was 98 percent (78/80), the two-level fusion rate was 82 percent (22/27), and the three-level fusion rate was 100 percent (3/3). In total, 94 percent of patients achieved arthrodesis.
Fusion rate was assessed using fine cut coronal CT scans. Treatment was shown to provide favorable clinical outcomes in patients who undergo ALIF surgery for degenerative spine conditions by facilitating successful fusion of two or more vertebrae, also known as arthrodesis. In the non-blinded study, a total of 110 patients were treated with i-FACTOR biologic bone graft and evaluated for fusion rates and clinical outcomes with a mean follow-up of two years. Mobbs, MD, Prince of Wales Hospital in Australia. Findings from the study, entitled, "Clinical Outcomes and Fusion Rates Following Anterior Lumbar Interbody Fusion with Bone Graft Substitute 'i-FACTOR' – an ABM/P-15 Composite," were presented by the research team led by Ralph J. Cerapedics, a privately-held orthobiologics company, today announced that results from the first prospective clinical study evaluating the safety and efficacy of i-FACTOR bone graft in anterior lumbar interbody fusion (ALIF) have been published in the peer-reviewed Journal of Neurosurgery: Spine.
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