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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Multicenter Study Clinical Trial
Clinical evaluation of the preliminary safety and effectiveness of a minimally invasive interspinous process device APERIUS(®) in degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication.
New interspinous process decompression devices (IPDs) provide an alternative to conservative treatment and decompressive surgery for patients with neurogenic intermittent claudication (NIC) due to degenerative lumbar spinal stenosis (DLSS). APERIUS(®) is a minimally invasive IPD that can be implanted percutaneously. This multicentre prospective study was designed to make a preliminary evaluation of safety and effectiveness of this IPD up to 12 months post-implantation. ⋯ Overall, in a period of up to 12 months follow-up, the safety and effectiveness of the APERIUS(®) offered a minimally invasive option for the relief of NIC complaints in a high proportion of patients. Further studies are underway to provide insight on outcomes and effectiveness compared to other decompression methods, and to develop guidance on optimal patient selection.
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Multicenter Study
Risk factors for major peri-operative complications in adult spinal deformity surgery: a multi-center review of 953 consecutive patients.
Major peri-operative complications for adult spinal deformity (ASD) surgery remain common. However, risk factors have not been clearly defined. Our objective was to identify patient and surgical parameters that correlate with the development of major peri-operative complications with ASD surgery. ⋯ The major peri-operative complication rate was 8.4 % for 953 surgically treated ASD patients. Significantly higher rates of complications were associated with staged and combined anterior-posterior surgeries. None of the patient factors assessed were significantly associated with the occurrence of major peri-operative complications. Improved understanding of risk profiles and procedure-related parameters may be useful for patient counseling and efforts to reduce complication rates.