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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.
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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. 20, 2014 /PRNewswire/ - 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. It also covers international bone grafts not yet approved in the United States and upcoming technologies in bone grafts.WESTMINSTER, Colo., Oct. This review covers all FDA-approved bone regeneration therapies such as the “gold standard” autografts, allografts, synthetic bone grafts, and the newer growth factors/bioactive molecules. There is a need of a bone regeneration method of similar quality of an autograft that is osteoconductive, osteoinductive, and osteogenic. Growth factors and bioactive molecules show some promising results in bone regeneration, although more research is needed to avoid their adverse effects and learn about the long-term effects of these therapies. P-15 was found to be effective, safe, and have similar outcomes to autograft at 2 years post-op for cervical radiculopathy due to cervical degenerative disc disease. There is also an FDA-approved bioactive molecule for bone regeneration, a peptide P-15. PDGF-BB grafts in studies have shown PDGF had similar fusion rates to autologous grafts and fewer adverse effects. BMP-7 is no longer an option for bone regeneration as it has withdrawn off the market. BMP-2 may also be advantageous for patients not willing to give up smoking as it shows bone regeneration success with smokers. BMP-2 has many adverse effects such as inflammatory complications such as massive soft-tissue swelling that can compromise a patient's airway, ectopic bone formation, and tumor formation. Although, BMP shows promising results as being an alternative to autograft, it also has its own downfalls. Growth factors such as recombinant BMP-2, BMP-7, and PDGF are FDA-approved therapies in bone regeneration. To induce bone regeneration there is a complex cascade of growth factors.