Journal of neurosurgery. Spine
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Randomized Controlled Trial Multicenter Study Comparative Study
Cervical disc arthroplasty with the Prestige LP disc versus anterior cervical discectomy and fusion, at 2 levels: results of a prospective, multicenter randomized controlled clinical trial at 24 months.
OBJECTIVE The authors compared the efficacy and safety of arthroplasty using the Prestige LP cervical disc with those of anterior cervical discectomy and fusion (ACDF) for the treatment of degenerative disc disease (DDD) at 2 adjacent levels. METHODS Patients from 30 investigational sites were randomized to 1 of 2 groups: investigational patients (209) underwent arthroplasty using a Prestige LP artificial disc, and control patients (188) underwent ACDF with a cortical ring allograft and anterior cervical plate. Patients were evaluated preoperatively, intraoperatively, and at 1.5, 3, 6, 12, and 24 months postoperatively. ⋯ At 24 months, heterotopic ossification was identified in 27.8% (55/198) of the superior levels and 36.4% (72/198) of the inferior levels of investigational patients. CONCLUSIONS Arthroplasty with the Prestige LP cervical disc is as effective and safe as ACDF for the treatment of cervical DDD at 2 contiguous levels and is an alternative treatment for intractable radiculopathy or myelopathy at 2 adjacent levels. Clinical trial registration no.: NCT00637156 ( clinicaltrials.gov ).
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OBJECTIVE Systematic multidisciplinary approaches to improving quality and safety in complex surgical care have shown promise. Complication rates from complex spine surgery range from 10% to 90% for all surgeries, and the overall mortality rate is 1%-4%. These rates suggest the need for improved perioperative complex spine surgery processes designed to minimize risk and improve quality. ⋯ A trend toward fewer deaths in this group was also found. CONCLUSIONS This type of systematic quality improvement strategy can improve quality and patient safety and might be applicable to other complex surgical disciplines. Implementation of these strategies in the treatment of adult spinal deformity will likely lead to better patient outcomes.
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OBJECTIVE Quality and outcomes registry platforms lie at the center of many emerging evidence-driven reform models. Specifically, clinical registry data are progressively informing health care decision-making. In this analysis, the authors used data from a national prospective outcomes registry (the Quality Outcomes Database) to develop a predictive model for 12-month postoperative pain, disability, and quality of life (QOL) in patients undergoing elective lumbar spine surgery. ⋯ CONCLUSIONS This study found that preoperative patient-specific factors derived from a prospective national outcomes registry significantly influence PRO measures of treatment effectiveness at 12 months after lumbar surgery. Novel predictive models constructed with these data hold the potential to improve surgical effectiveness and the overall value of spine surgery by optimizing patient selection and identifying important modifiable factors before a surgery even takes place. Furthermore, these models can advance patient-focused care when used as shared decision-making tools during preoperative patient counseling.
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OBJECTIVE The authors conducted a study to compare neurological deficit rates associated with complex adult spinal deformity (ASD) surgery when recorded in retrospective and prospective studies. Retrospective studies may underreport neurological deficits due to selection, detection, and recall biases. Prospective studies are expensive and more difficult to perform, but they likely provide more accurate estimates of new neurological deficit rates. ⋯ The majority of deficits in both studies were at the nerve root level, and the distribution of level of injury was similar. CONCLUSIONS New neurological deficit rates were nearly twice as high in the prospective study than the retrospective study with identical inclusion criteria. These findings validate concerns regarding retrospective cohort studies and confirm the need for and value of carefully designed prospective, observational cohort studies in ASD.
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OBJECTIVE The aim of this study was to investigate the risk of upper instrumented vertebra (UIV) fractures associated with UIV screw fixation (unicortical vs bicortical) and polymethylmethacrylate (PMMA) augmentation after adult spinal deformity surgery. METHODS A single-center, single-surgeon consecutive series of adult patients who underwent lumbar fusion for ≥ 4 levels (that is, the lower instrumented vertebra at the sacrum or pelvis and the UIV of the thoracolumbar spine [T9-L2]) were retrospectively reviewed. Age, sex, follow-up duration, sagittal UIV angle immediately postoperatively including several balance-related parameters (lumbar lordosis [LL], pelvic incidence, and sagittal vertical axis), bone mineral density, UIV screw fixation type, UIV PMMA augmentation, and UIV fracture were evaluated. ⋯ UIV bicortical screw fixation increased the risk for UIV fracture (OR 5.39; p = 0.02). CONCLUSIONS Bicortical screw fixation at the UIV is a major risk factor for early UIV compression fracture, regardless of whether a thoracolumbosacral orthosis is used. To reduce the proximal junctional failure, unicortical screw fixation at the UIV is essential in adult spinal deformity correction surgery.