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Stryker Corporation Message Board

  • dr_roger_m dr_roger_m Dec 30, 2012 10:56 AM Flag

    Due diligence on Medtronic, Stryker Biotech and Bacterin...

    As part of my efforts to perform comprehensive due diligence in the lower back pain/spinal fusion device arena, specifically on Medtronic, Stryker Biotech and Bacterin I have outstanding questions that I would very much appreciate the answers to. I will post these questions on the Medtronic, Stryker Biotech and Bacterin Yahoo message boards and hopefully get a balanced response...

    Doctors Mroz, Wang, Hashimoto and Norvell performed a systematic review of the complications related to the use of rhBMP2 and rhBMP7 for lumbar and cervical spinal fusions (Thomas E. Mroz, MD, Jeffrey C. Wang, MD, Robin Hashimoto, PhD and Daniel C. Norvell, PhD “Complications Related to Osteobiologics Use in Spine Surgery, A Systematic Review” SPINE Volume 35, Number 9S, pp S86–S104) in which they concluded that use of rhBMP2 (InFUSE with LT-CAGE, Medtronic) and rhBMP7 (OP-1 Putty, Stryker Biotech) has been associated with a variety of unique complications in the ventral cervical and lumbar spines (summarized in the Appendix below). One commonly discussed but as far as I am aware unproven hypothesis for at least some of the complications recently reported with Medtronic’s InFUSE device and Stryker Biotech’s OP-1 Putty is the initial unnaturally extremely high concentration of rhBMP that is released from the collagen sponge immediately following implantation. Is anyone aware of any publications that actually carefully measure just how much rhBMP is released from the collagen sponge over time? Also, what is the half-life of rhBMP2 and rhBMP7? If rhBMP2 and rhBMP7 could be bioengineered to be more stable (i.e. longer half-life) could lower levels be used while still retaining the same spinal fusion success rate and might this putative bioengineered version help significantly reduce future complications and improve safety? Finally, what is the OsteoSponge created by Bacterin, why was this not included in Mroz et al study (too new perhaps?), what BMPs (if any) does the OsteoSponge contain (I checked on their website and could not find the relevant info) and how do the OsteoSponge’s complications compare with those reported for InFUSE and OP-1? I would be extremely grateful for responses to any one of these questions.

    Kind regards – Roger

    Appendix: complications associated with rhBMP use in spine surgery.
    Complications associated with rhBMP use in lumbar spine surgery included: Resorption/osteolysis in up to 100% of cases, with a mean of 44%, Extradiscal, ectopic, or heterotopic bone formation in up to 75% of cases, with a mean of 8%, Graft subsidence in up to 62% of cases, with a mean of 25%, Cage migration in up to 35% of cases, with a mean of 27%, Dysphagia, neck swelling, respiratory difficulties in up to 0.3% of cases, with a mean of 0.3%, Elevated antibody response to rhBMP-2 in up to 5% of cases, with a mean of 1%, Presence of neutralizing antibodies against rhBMP-7 in up to 26% of cases, with a mean of 26%, Elevated antibody response to bovine type I collagen in up to 27% of cases, with a mean of 16%, Wound complications in up to 2% of cases, with a mean of 2%, Hematoma in up to 9% of cases, with a mean of 4%, Wound infection or dehiscence in up to 17% of cases, with a mean of 3%, Radiculitis in up to 11% of cases, with a mean of 11%, Inflammatory response to collagen carrier in up to 29% of cases, with a mean of 29%, and complications associated with BMP use in cervical spine surgery included: Resorption/osteolysis in up to 100% of cases, with a mean of 43%, Extradiscal, ectopic, or heterotopic bone formation in up to 13% of cases, with a mean of 3%, Graft subsidence in up to 44% of cases, with a mean of 43%, Cage migration in up to 4% of cases, with a mean of 2%, Dysphagia, neck swelling, respiratory difficulties in up to 85% of cases, with a mean of 5.8%, Elevated antibody response to bovine type I collagen in up to 7% of cases, with a mean of 7%, Wound complications in up to 1.4% of cases, with a mean of 1.4%, Hematoma in up to 10% of cases, with a mean of 5%, Seroma in up to 1% of cases, with a mean of 1%, Wound infection in up to 15% of cases, with a mean of 9%.

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