Browsing by Author "Fleming, Thomas"

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    A Case Series and Discussion on Surgical Treatment Strategy for Atypical Proximal Femoral Fractures Associated with Bisphosphonate Use.
    (Cureus, 2018-12) Rocos, Brett; Fleming, Thomas; Harding, Karen; Acharya, Mehool; Riddick, Andrew; Kelly, Mike
    The aim of this study was to determine the incidence of atypical femoral fractures in our local population, study their current outcomes and present a novel surgical strategy based on these data. Patients who received surgical fixation of an atypical pattern proximal femoral fracture over a four-year period were identified and followed up in the clinic until union, revision surgery or death. The local incidence of atypical femoral fractures is 1.1 per 1000 per annum amongst patients receiving bisphosphonates. Twelve fixation procedures were carried out in 10 patients. Intra-operative reduction and nailing led to an average deformity of 8.5° varus and 13° apex anterior. Five cases required revision surgery. Fifty percent of primary procedures resulted in radiographic union within two years. We suggest that the lateral side of the fracture should be considered a primary nonunion. We advocate undertaking a wedge excision to correct the bone to a valgus morphology and stabilising with an intramedullary nail and a lateral tension plate. Multicentre studies are needed to demonstrate the efficacy of any particular approach.
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    Issues in regulatory guidelines for data monitoring committees.
    (Clin Trials, 2004) DeMets, David; Califf, Robert; Dixon, Dennis; Ellenberg, Susan; Fleming, Thomas; Held, Peter; Julian, Desmond; Kaplan, Richard; Levine, Robert; Neaton, James; Packer, Milton; Pocock, Stuart; Rockhold, Frank; Seto, Belinda; Siegel, Jay; Snapinn, Steve; Stump, David; Temple, Robert; Whitley, Richard
    As clinical trials have emerged as the major research method for evaluating new interventions, the process for monitoring intervention safety and benefit has also evolved. The Data Monitoring Committee (DMC) has become the standard approach to implement this responsibility for many Phase III trials. Recent draft guidelines on the operation of DMCs by the Food and Drug Administration (FDA) have raised issues that need further clarification or discussion, especially for industry sponsored trials. These include, the time when DMCs are needed, the role of the independent statistician to support the DMC, and sponsor participation at DMC meetings. This paper provides an overview of these issues, based on the discussions at the January, 2003 workshop sponsored by Duke Clinical Research Institute.