Journal of neurosurgery. Spine
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Multicenter Study Comparative Study Controlled Clinical Trial
Heterotopic ossification following single-level anterior cervical discectomy and fusion: results from the prospective, multicenter, historically controlled trial comparing allograft to an optimized dose of rhBMP-2.
OBJECTIVE Heterotopic ossification (HO) has been reported following total hip, knee, cervical, and lumbar arthroplasty, as well as following posterolateral lumbar fusion using recombinant human bone morphogenetic protein-2 (rhBMP-2). Data regarding HO following anterior cervical discectomy and fusion (ACDF) with rhBMP-2 are sparse. A subanalysis was done of the prospective, multicenter, investigational device exemption trial that compared rhBMP-2 on an absorbable collagen sponge (ACS) versus allograft in ACDF for patients with symptomatic single-level cervical degenerative disc disease. ⋯ The impact of Park Grades 2 and 3 HO on Neck Disability Index success, neurological status, and overall success was not consistent among the treatment groups. The study data may offer a deeper understanding of HO after ACDF and may pave the way for improved device designs. Clinical trial registration no.: IDE# G060021; data compared with pooled data from control arms of IDE# G010188/NCT00642876 and IDE# G000123/NCT00437190 ( www.clinicaltrials.gov ).
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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 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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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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Multicenter Study
Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation.
OBJECTIVE Cervical spinal cord stimulation (cSCS) is used to treat pain of the cervical region and upper extremities. Case reports and small series have shown a relatively low risk of complication after cSCS, with only a single reported case of perioperative spinal cord injury in the literature. Catastrophic cSCS-associated spinal cord injury remains a concern as a result of underreporting. ⋯ CONCLUSIONS In the largest series of cSCS, the risk of spinal cord injury was higher than previously reported (0.5%). Nonetheless, this procedure remains relatively safe, and physicians may use these data to corroborate the safety of cSCS in an appropriately selected patient population. This may become a key treatment option in an increasingly opioid-dependent, aging population.