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  • Clinical Experience with Prodisc-L in Medicaid Patients in a Community Hospital

    Final Number:
    1212

    Authors:
    Narayan Sundaresan MD; Yilmaz Gunduz; Jose Torres-Gluck; Nicholas H. Post MD; Radha Sinha

    Study Design:
    Clinical Trial

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2011 Annual Meeting

    Introduction: Lumbar disc arthroplasty with PRODISC-L has been shown in several pivotal IDE studies to be superior or equal to fusion for lumbar degenerative disease. Nevertheless, private insurers and CMS deny reimbursement citing "experimental" or "not applicable in community setting" as reasons for denial. We therefore reviewed the result of 55 single level PRODISC-L disc replacements in a community hospital with coverage predominantly by Medicaid to determine its comparative effectiveness in the community setting.

    Methods: Following IRB approval, a retrospective review of 54 single level patients meeting FDA approved criteria over a 2 level period (2008-2010) were performed. Pre-operative and post-operative evaluation specifically focussed on technical complications, improvement in neurological deficits, length of stay, implant failures, and the need for secondary surgery at the index and adjacent levels.

    Results: There were 30 females, 25 males with ages ranging from 22-60 years; surgery was performed at L5-S1 in 24, L4-L5 in 26 , and L3-L4 in 5 patients. 5 pts had failed prior surgery(discectomy).No intra-operative vascular injuries, implant failures, or infections were nited. Secondary surgery was required in 2/55 pts, secondary to pars fractures posteriorly. No adjacent level disease was requiring surgery was noted. The median length of stay was 8 days.

    Conclusions: Disc replacement with PRODISC-L can be safely performed in the coomunity setting provided experienced access surgeons and technical facilities are available. The clinical results in this series are comparable to participating IDE centers, with results superior to fusion surgery. Length of stay in the Medicaid group is not a surrogate marker for morbidity, and implant costs and resource utilization are less than fusion surgery.

    Patient Care: Improved access to disc replacement in community hospitals

    Learning Objectives: PRODISC-L Disc arthroplasty is safe and effective when performed in community hospitals with the necessary expertise.

    References:

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