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  • First Interim North American Results of a Multicentre, blinded, pilot study of a Novel Peptide in promoting Lumbar Spine Fusion.

    Final Number:

    Peter Jarzem BSc(Eng), MD, FRCSC; Zeeshan Sardar MD.CM., M.Sc; Greg Anderson MD

    Study Design:
    Clinical Trial

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2012 Annual Meeting

    Introduction: Fusion failure in transforaminal lumbar interbody fusion(TLIF) procedures is a challenging problem that can lead to poor functional outcomes. B2A is a synthetic peptide that has proven efficacy in achieving fusion in animal models and may be a cheaper but safer alternative to other BMPs while avoiding iliac crest bone graft (ICBG) harvesting morbidity.

    Methods: This is a multicenter North American, prospective pilot study. Skeletally mature patients with Degenerative Disc Disease(DDD) at L2-S1 requiring single level TLIF were randomized to 3 groups: ICBG, Prefix concentration 150µg and Prefix concentration 750µg. 39 patients (13 Control, 19 Prefix 150, 7 Prefix 750, 24 Canada, 15 USA, 19 males, 20 females) were enrolled between 2009-2010. Outcome measures included Oswestry Disability Index(ODI), Visual Analog pain Scale(VAS), and fusion as assessed by CT and dynamic flexion/extension x-rays. Patients were evaluated at 6 weeks, 3, 6 and 12 months after surgery.

    Results: Blood loss during surgery was higher in ICBG (431cc) than both Prefix 150 (251cc) and Prefix 750 (314cc). Fusion at 6 months was 42%, 32%, and 71% for ICBG, low and high dose, respectively. At 12 months, fusion was 83%, 50%, and 100% for ICBG, Prefix 150 and 750 respectively. The mean ODI was 19.9 for ICBG, 31.1 for Prefix 750 and 27.8 for Prefix 150 at 12 months; differences were not statistically significant. There were no significant differences in serum chemistry between groups. No subjects developed antibodies to B2A. Complications included; 1 adjacent level infection needing reoperation (Prefix 750), 1 seroma that was drained without consequence (Prefix 150), 2 reoperations due to non-union (Prefix 150).

    Conclusions: Prefix provides a safe alternative to ICBG and avoids donor site morbidity. Prefix 750 showed superior fusion rate to autograft at 12 months. Both Prefix groups and autograft were equivalent in improving ODI at all time-points up to 12 months.

    Patient Care: A synthetic BMP can lower patient morbidity during spinal fusion with an acceptable safety profile

    Learning Objectives: By the conclusion of this session paticipants should be able to understand the advantages and disadvantages of different graft options for acheiving spine fusion.

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