European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
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International Standards Organization (ISO) 12189 and American Society for Testing and Materials F2624 are two standard material specification and test methods for spinal implant devices. The aim of this study was to assess whether the existing and required tests before market launch are sufficient. ⋯ Spinal implants have to be checked by a notified body before market launch. The notified body verifies whether the implants fulfil the requirements of the current standards. These declared studies suggest that the current standards for the testing of load bearing capacity and stand ability of dynamic spine implants might be insufficient. Revised standards depicting sufficient deformation and load pattern have to be developed and counted as a requirement for the market launch of an implant. These slides can be retrieved under Electronic Supplementary Material.
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The author "Ashish D. Diwan" receives educational consultant fees from Nuvasive Inc.
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Case Reports
Retroperitoneal haematoma in a postoperative ALIF patient taking rivaroxaban for atrial fibrillation.
Novel oral anticoagulants (NOACs) are being increasingly used in the secondary prevention of thromboembolic stroke in patients with atrial fibrillation. Patients taking NOACs are difficult to manage perioperatively, and several unexpected complications have been reported in these patients. ⋯ This is the first case of a rivaroxaban-induced retroperitoneal haematoma reported in the literature, secondary to elective spinal surgery. This report adds to the body of evidence on the risk of postoperative bleeding in patients taking NOACs. If patients on NOACs present with abdominal symptoms following anterior approach to the lumbar spine, treating clinicians should have a high index of suspicion for retroperitoneal haematoma.
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The aim of this study was to investigate the difference in patient-reported outcomes and surgical complication rates between lumbar procedures carried out either by experienced board-certified spine surgeons (BCS) or by supervised spine surgery residents (RES) in a large Swiss teaching hospital. ⋯ In the given setting, surgical training of spine surgery residents under guided supervision by board-certified spine surgeons was shown to be safe, as it was not associated with greater morbidity or mortality. Furthermore, it had no detrimental influence on patient-reported outcomes. The findings can be used to give reassurance to prospective patients that are to be operated on by supervised spine surgery residents. These slides can be retrieved under Electronic Supplementary Material.
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Abnormalities of the lumbar nerve tract caused by congenital variations or high nerve root take-off angles are difficult to visualize. Diffusion-weighted magnetic resonance neurography (DW-MRN) has recently been introduced for imaging of the lumbosacral region. The aims of this study were to identify lumbar nerve tract abnormalities caused by congenital variation or a high nerve root take-off angle using DW-MRN and to assess the diagnostic value of this imaging modality. ⋯ Congenital variations were identified in 8 patients (9 nerve roots, 1.6%). The most commonly identified variation was in the sacral nerve root (n = 5) followed by the L4 (n = 3) and L5 (n = 1) nerve roots. All variations identified were on the left side. There were 3 cases of type 1a variation, 1 of type 1b, 1 of type 2, and 4 of type 3. In total, 210 (36.6%) of the magnetic resonance images showed high nerve root take-off angles at the intervertebral foramen that was caused by disk herniation, spondylolisthesis, or osteophytes with degeneration. Patients with high nerve root take-off angles were significantly older than those without (P < 0.05). These slides can be retrieved under Electronic Supplementary Material.