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  • A Blinded, Multi-Center Clinical and Radiological Study to Evaluate the Use of OsteoAMP versus rhBMP-2 in TLIF/LLIF Procedures

    Final Number:
    159

    Authors:
    Christopher Yeung MD; Justin Field MD; Jeffrey Roh MD

    Study Design:
    Clinical Trial

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2013 Annual Meeting

    Introduction: Adverse events and complications related to use of rhBMP-2 have raised many ethical, legal, and reimbursement concerns for surgeons. OsteoAMP® bone graft is an allograft derived growth factor available on the market rich in osteoinductive, angiogenic, and mitogenic proteins. The following data displays a blinded, multi -center study evaluating and comparing fusion outcomes between rhBMP-2 and OsteoAMP® bone graft.

    Methods: A total of 247 consecutive patients (368 total levels) were treated with TLIF or LLIF spine fusion procedures. A group of 68 patients (53.4 ± 11.1 y/o) were treated with rhBMP-2 (Infuse®, Medtronic) and local bone with an average of 1.44 levels per surgery. A group of 179 patients (60.3 ± 12.9 y/o) were treated with OsteoAMP® (Advanced Biologics) and local bone with an average of 1.51 levels per surgery. Fusion assessments were made by a blinded independent radiologist based on radiograph and CT images at 6w, 3m, 6m, 12m, and 18m follow up.

    Results: Fusion analysis showed superiority in efficacy of OsteoAMP® over rhBMP-2 at all time points (p=0.02). Use of rhBMP-2 produced limited early fusions at 6 months (22.4%) yet improved at 1 year (70.3%). OsteoAMP® facilitated fusion for the majority of patient by 6 months (55.1%) and nearly all patients within 1 year (94.5%). At 18 months, 100% of OsteoAMP® patients had fused while the rhBMP-2 arm had an 86.7% fusion rate. Total time for fusion for OsteoAMP® was less than half of rhBMP-2 at 205.3 and 417.6 days respectively. The rhBMP-2 arm had approximately 6 times the radiologically evident adverse event rate (osteolysis and ectopic bone formation) compared to the OsteoAMP® arm (45.6% vs. 7.9%, respectively).

    Conclusions: Despite its use with an older patient population and a higher number of levels per surgery, OsteoAMP® has shown great promise as a faster and safer alternative to rhBMP-2.

    Patient Care: Providing a safer high efficacy alternative to rhBMP-2 for spine fusions.

    Learning Objectives: Identify an effective alternative for rhBMP-2 in lumbar spine fusions.

    References: Infuse, rhBMP-2, rh-BMP2, biologic, osteobiologic, OsteoAMP, bone graft, growth factor, dbm, TLIF, LLIF, spine, spine fusion, spinal fusion, arthrodesis

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