BackgroundAnterior cervical discectomy and fusion (ACDF) is the gold standard for treating symptomatic cervical disc degeneration. Cervical total disc replacements (TDRs) have emerged as an alternative for some patients. The purpose of this study was to evaluate the safety and effectiveness of a new TDR device compared with ACDF for treating single-level cervical disc degeneration.MethodsThis was a prospective, randomized, controlled, multicenter Food and Drug Administration (FDA) regulated Investigational Device Exemption (IDE) study. A total of 245 patients were treated (164 TDR: 81 ACDF). The primary outcome measure was overall success based on improvement in Neck Disability Index (NDI), no subsequent surgical interventions, and no adverse events (AEs) classified as major complications.Secondary outcome measures included SF-12, visual analog scale (VAS) assessing neck and arm pain, patient satisfaction, radiographic range of motion, and adjacent level degeneration. Patients were evaluated preoperatively and postoperatively at 6 weeks, 3, 6, 12, 18, and 24 months. The hypothesis was that the TDR success rate was non-inferior to ACDF at 24 months.ResultsOverall success rates were 73.6% for TDR and 65.3% for ACDF, confirming non-inferiority (p < 0.0025). TDR demonstrated earlier improvements with significant differences in NDI scores at 6 weeks and 3 months, and VAS neck pain and SF-12 PCS scores at 6 weeks (p<0.05). Operative level range of motion in the TDR group was maintained throughout follow-up. Radiographic evidence of inferior adjacent segment degeneration was significantly greater with ACDF at 12 and 24 months (p < 0.05). AE rates were similar.ConclusionsMobi-C TDR is a safe and effective treatment for single-level disc degeneration, producing outcomes similar to ACDF with less adjacent segment degeneration. Level of Evidence: Level I.Clinical relevance: This study adds to the literature supporting cervical TDR as a viable option to ACDF in appropriately selected patients with disc degeneration.
Significant improvements were observed in pain and function. TDR patients maintained motion and had significantly lower rates of reoperation and adjacent-segment degeneration compared with ACDF. This study supports the safety and efficacy of TDR in appropriately selected patients.
The Continuous Performance Test has been used for the last 40 years to measure sustained attention or vigilance in many different populations. Different versions of the test have been developed, but little is known about how similar these tests are, and to what extent performance on different versions of these tests overlaps. In order to examine convergence of the different versions of the CPT, three different CPTs were administered in both the Auditory and Visual Sensory Modalities. Subjects were selected from consecutive admissions to adolescent acute care units at a private psychiatric hospital (n=100). Auditory test modalities uniformly elicited poorer performance than visual tests, while each set of task demands consistently elicited differences in performance. Despite the high test-retest reliability of the individual subtests, the average correlation between tests was r=.42, with the average correlation between visual tests at r=.48 and the average correlation between the auditory tests was r=.45. The correlations within task demands across sensory modalities ranged from a low of.37 to a high of.52. Controlling for IQ did not influence the correlations to a substantial degree. These data suggest different versions of the CPT are correlated with each other at a level consistent with construct validity, but that they do not constitute alternate forms of the same test.
Failure in medication compliance in adult psychiatric patients is often found to be due to side effects or associated with unawareness of illness. Little research has been conducted on medication compliance in adolescent psychiatric patients. In this study, 97 adolescent psychiatric patients, including 46 with substance abuse, were followed up an average of 14 months after their discharge from inpatient psychiatric care. Compliance with prescribed medications was examined and the association between several potential predictors and compliance was examined. The overall rate of medication compliance was only 38% at 14-month follow-up, whereas the rate of patients stopping their medications because of side effects was only 23%. Significant predictors of compliance failures were general noncompliance with the discharge plan, followed by postdischarge substance abuse. Side effects did not contribute any additional variance when these factors were considered. These data suggest that medication compliance may be adversely impacted by general tendencies toward noncompliance with treatment, which may be mediated by several possible factors. Interventions to increase awareness of the need for psychotropic medications as well as careful monitoring for substance abuse relapse in this population are suggested.
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