Journal of neurosurgery. Spine
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Multicenter Study Observational Study
Inadequacy of 3-month Oswestry Disability Index outcome for assessing individual longer-term patient experience after lumbar spine surgery.
OBJECTIVE Prospective longitudinal outcomes registries are at the center of evidence-driven health care reform. Obtaining real-world outcomes data at 12 months can be costly and challenging. In the present study, the authors analyzed whether 3-month outcome measurements sufficiently represent 12-month outcomes for patients with degenerative lumbar disease undergoing surgery. ⋯ The discordance rates of achieving or not achieving MCID for ODI were in the range of 19% to 27% for all diagnoses and treatments (decompression with and without fusion). The positive and negative predictive value of 3-months ODI to predict 12-month ODI was 86% and 60% for MCID and 82% and 67% for SCB. CONCLUSIONS Based on their findings, the authors conclude the following: 1) Predictive methods for functional outcome based on early patient experience (i.e., baseline and/or 3-month data) should be used to help evaluate the effectiveness of procedures in patient populations, rather than serving as a proxy for long-term individual patient experience. 2) Prospective longitudinal registries need to span at least 12 months to determine the effectiveness of spine care at the individual patient and practitioner level.
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Randomized Controlled Trial Multicenter Study Comparative Study
Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial.
OBJECTIVE The purpose of this study was to report the outcome of a study of 2-level cervical total disc replacement (Mobi-C) versus anterior cervical discectomy and fusion (ACDF). Although the long-term outcome of single-level disc replacement has been extensively described, there have not been previous reports of the 5-year outcome of 2-level cervical disc replacement. METHODS This study reports the 5-year results of a prospective, randomized US FDA investigational device exemption (IDE) study conducted at 24 centers in patients with 2-level, contiguous, cervical spondylosis. ⋯ However, there was significantly greater improvement in general and disease-specific outcome measures and a lower rate of reoperation in the 2-level disc replacement patients versus ACDF control patients. Clinical trial registration no. NCT00389597 ( clinicaltrials.gov ).
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Multicenter Study
Spinal Adverse Events Severity System, version 2 (SAVES-V2): inter- and intraobserver reliability assessment.
OBJECTIVE Reporting of adverse events (AEs) in spinal surgery uses inconsistent definitions and severity grading, making it difficult to compare results between studies. The Spinal Adverse Events Severity System, version 2 (SAVES-V2) aims to standardize the classification of spine surgery AEs; however, its inter- and intraobserver reliability are unknown. The objective of this study was to assess inter- and intraobserver reliability of the SAVES-V2 grading system for assessing AEs in spinal surgery. ⋯ Agreement on impact of the AE on LOS was excellent in the DSSG and fair in the STSG. CONCLUSIONS There was good agreement on the presence, severity, and number of AEs in both trauma and degenerative cases in using the SAVES-V2. This grading system is a simple, reliable tool for identifying and capturing AEs in spinal surgery.
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OBJECTIVE The accuracy of public reporting in health care is an issue of debate. The authors investigated the association of patient satisfaction measures from a public reporting platform with objective outcomes for patients undergoing spine surgery. METHODS The authors performed a cohort study involving patients undergoing elective spine surgery from 2009 to 2013 who were registered in the New York Statewide Planning and Research Cooperative System database. ⋯ Similar associations were identified for hospitals with a higher percentage of patients who claimed they would recommend these institutions to others. CONCLUSIONS Merging a comprehensive all-payer cohort of spine surgery patients in New York state with data from the CMS Hospital Compare website, the authors were not able to demonstrate an association of improved performance in patient satisfaction measures with decreased mortality, rate of discharge to rehabilitation, and hospitalization charges. Increased patient satisfaction was associated with decreased LOS.
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OBJECTIVE There have been no reports on the long-term radiographic outcomes of posterior vertebral column resection (PVCR) in patients with congenital scoliosis. The purpose of this study was to evaluate the surgical outcomes and complications after PVCR and its long-term effects on correcting this deformity in children with congenital scoliosis. METHODS The authors retrospectively analyzed the medical records of 45 patients with congenital scoliosis who were younger than 18 years at the time of surgery and who underwent PVCR and fusion with pedicle screw fixation (PSF). ⋯ CONCLUSIONS Posterior vertebral column resection is an effective procedure for managing congenital scoliosis in patients younger than 18 years. Use of PVCR and fusion with PSF for congenital scoliosis achieved rigid fixation and satisfactory deformity correction that was maintained over the long term. However, the authors note that PVCR is a technically demanding procedure and entails risks for major complications and excessive blood loss.