The spine journal : official journal of the North American Spine Society
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Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. ⋯ Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose.
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Rapid and stable fixation at the bone-implant interface would be regarded as one of the primary goals to achieve clinical efficacy, regardless of the surgical site. Although mechanical and physical properties of polyetheretherketone (PEEK) provide advantages for implant devices, the hydrophobic nature and the lack of direct bone contact remains a limitation. ⋯ Direct bone to implant bonding can be achieved on PEEK in spite of its hydrophobic nature using a plasma-sprayed titanium coating. The plasma-sprayed titanium coating improved mechanical properties in the cortical sites and the histology in cortical and cancellous sites.
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Review Meta Analysis
Anterior lumbar spine surgery: a systematic review and meta-analysis of associated complications.
The anterior approach to the lumbar spine is increasingly used to accomplish various surgical procedures. However, the incidence and risk factors for complications associated with anterior lumbar spine surgery (ALS) have not been fully elucidated. ⋯ Overall complication rates with ALS are relatively low, with the most common complications occurring at a rate of 1% to 3%. Complication rates are related to surgical technique, approach, and implant characteristics. Further randomized controlled trials are needed to validate the use of preventative measures including CTA and the use of an access surgeon.
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The treatment of osteoporotic vertebral compression fractures using transpedicular cement augmentation has grown significantly during the past two decades. Balloon kyphoplasty was developed to restore vertebral height and improve sagittal alignment. Several studies have shown these theoretical improvements cannot be transferred universally to the clinical setting. ⋯ For anterior height restoration (BKP, 0.14±1.48 mm; SJ, 3.34±1.19 mm), central height restoration (BKP, 0.91±1.04 mm; SJ, 3.24±1.22 mm), and posterior restoration (BKP, 0.37±0.57 mm; SJ, 1.26±1.05), as well as the Beck index (BKP, 0.00±0.06 mm; SJ, 0.10±0.06), the values for the SpineJack group were significantly higher (p<.05) CONCLUSION: The protocols for creating wedge fractures and using the instrumentation under a constant preload of 100 N led to reproducible results and effects. The study showed that height restoration was significantly better in the SpineJack group compared with the balloon kyphoplasty group. The clinical implications include a better restoration of the sagittal balance of the spine and a reduction of the kyphotic deformity, which may relate to clinical outcome and the biological healing process.
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Meta Analysis Comparative Study
A meta-analysis of cervical foraminotomy: open versus minimally-invasive techniques.
The posterior cervical foraminotomy (PCF) may be performed using an open or minimally-invasive (MIS) approach using a tubular retractor. Although there are theoretical advantages such as less blood loss and shorter hospitalizations, there is no consensus in the literature regarding the best approach for treatment. ⋯ Patients with symptomatic cervical radiculopathy from foraminal stenosis can be effectively managed with either a traditional open or an MIS foraminotomy. There is no significant difference in the pooled outcomes between the two groups.