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The article discusses a study which evaluated the effectiveness of Oxiplex gel for reduction of pain and associated symptoms following discectomy. The study assessed patients undergoing lumbar discectomy performed by laminectomy or laminotomy and randomized to receive either surgery plus Oxiplex gel or surgery alone using a quality of life questionnaire. It found that the gel-treated group showed greater reductions in pain and symptoms from baseline compared with surgery-only controls.

Abstract: Background context: Carragee et al. have recently shown that modern discography injections are associated with subsequent acceleration of disc degeneration, herniation, and loss of disc height. Although needle puncture and pressurization are known trauma events that can create disc degeneration in animal models, another likely culprit in clinical discography–associated degeneration is a direct effect of the contrast agent itself on disc cells. Purpose: To test the hypothesis that discography contrast solution would have a deleterious effect on human annulus cells in vitro. Study design: An in vitro study using cultured human annulus cells to assay cell death, cell proliferation, and apoptosis. Patient sample: Annulus cells from eight surgical disc specimens were evaluated (two Thompson Grade III discs and six Grade IV discs) for cell death and proliferation, and an additional five cultures were tested for apoptosis. Outcome measures: The proportion of dead and live cells, cell proliferation, and the proportion of apoptotic cells in control and experimental groups. Methods: After internal review board approval, experimental design used two sets of controls: untreated cells under our normal culture conditions (control) and a set with added glucose to adjust the osmolality to match respective Isovue radiocontrast solution treatments (glucose controls) using a freezing point osmometer. Treated cells received Isovue 200 (iopamidol, Isovue-M 200; Bracco Diagnostics, Inc., Princeton, NJ, USA) at 12.5, 25, 50, or 100 mg/mL. Twenty thousand cells/well were seeded in triplicate in 24 well plates, control or test media added, and incubated for 24 hours. At termination, dead cells were identified with trypan blue staining and percentage dead cells determined. Cells were also tested to determine the percentage of apoptotic cells after 50 or 100 mg/mL Isovue exposures. Proliferation assays used standard plate reader methods. Statistical analysis used repeated measures analysis of variance with SAS software (version 9.2; SAS Institute, Inc., Cary, NC, USA). Results: Analysis of cell death showed a significant increase in the percentage of dead cells with increasing Isovue concentrations compared with control cells (p=.018–.0008). Cell proliferation analyses showed significantly reduced division in Isovue-treated cells (p=.004), and apoptosis assays revealed a significantly higher proportion of apoptotic cells in cells exposed to 50 and 100 mg/mL Isovue (p=.016 and .0003, respectively). Conclusions: Discography is used extensively in the evaluation of low back pain. Because the lifetime prevalence of disc degeneration and low back pain is high (80% in the general population), many patients may undergo this procedure. Data presented here show that cells exposed in vitro to a radiocontrast agent with adjustments for osmolality have significantly reduced proliferation, increased cell death, and increased programmed cell death (apoptosis). In light of the well-recognized age- and degeneration-related decrease in disc cell numbers, it is possible that radiocontrast exposure may be contributing significantly to disc cell loss with subsequent progression of disc degeneration. Findings presented here provide a plausible cell-based explanation for the previously reported disc degeneration in patients receiving discography contrast solutions. [Copyright &y& Elsevier]

Purpose: Many investigators have reported the financial conflicts of interest (COI), which could result in potential bias in the reporting of outcomes for patients undergoing total disc replacement (TDR) rather than anterior cervical discectomy and fusion (ACDF). This bias may be subconsciously introduced by the investigator in a non-blinded radiographic review. The purpose of this study was to determine if bias was present when a group of spine specialists rated adjacent segment degeneration (ASD) following cervical TDR or ACDF.Methods: Potential bias in the assessment of ASD was evaluated through the reviews of cervical radiographs (pre- and 6 years post-operative) from patients participating in the ProDisc-C FDA trial (ProDisc-C IDE #G030059). The index level was blinded on all radiographs during the first review, but unblinded in the second. Five reviewers (a radiologist, two non-TDR surgeons, and two TDR surgeons), two of whom had a COI with the ProDisc-C trial sponsor, assessed ASD on a three point scale: yes, no, or unable to assess. Intra- and inter-rater reliabilities between all raters were assessed by the Kappa statistic.Results: The intra-rater reliability between reviews was substantial, indicating little to no bias in assessing ASD development/progression. The Kappa statistics were 0.580 and 0.644 for the TDR surgeons (p < 0.0001), 0.718 and 0.572 for the non-TDR surgeons (p < 0.0001), and 0.642 for the radiologist (p < 0.0001). Inter-rater reliability for the blinded review ranged from 0.316 to 0.607 (p < 0.0001) and from 0.221 to 0.644 (p < 0.0001) for the unblinded review.Conclusions: The knowledge of the surgical procedure performed did not bias the assessment of ASD. [ABSTRACT FROM AUTHOR]

The relationship of the esophagus to the cervical vertebral body (CVB), disc space and longus colli (LC) muscles, to our knowledge, has not been previously studied. The purpose of this study was to quantify the relationship of the esophagus to the CVB, disc space and LC. 30 patients were selected for a retrospective review of computed tomography (CT) scans. Measurements between the esophagus and the C5, C6, and C7 vertebral bodies as well as the C5/6 and C6/7 disc spaces were performed in the midline, 3 mm right and left of midline, and at the edge of the LC on both sides. The closest distance of the esophagus to the CVB and disc space occurs at the midline (range 1.02-1.31 mm at each level). The furthest distance occurred at the edge of the right LC (range 2.67-3.30 mm at each level). The mean distance from the edge of the right LC to the midline was significantly greater (P < 0.01) than mean distance from the edge of the left LC to the midline. No statistical significant differences were observed when comparing measurements at the individual vertebral bodies and disc spaces. The results of the study demonstrate that the esophagus lies in closest proximity to the CVB and disc space in the midline. A larger potential space exists between the esophagus and the CVB and disc space at the edge of the LC. These results may provide insight into a potential cause of post-operative dysphagia. Furthermore, it may help guide the future design of cervical plates to better utilize the potential space between the esophagus and the CVB and disc space at the edge of the LC. [ABSTRACT FROM AUTHOR]

BACKGROUND CONTEXT Online physician and provider rating websites (OPRWs) are a commonly used resource for patients who seek a new physician. In 2010, nearly 40% of Americans utilized OPRWs prior to a new clinical visit. Prior studies have evaluated the manner and trends by which patients rate their physicians and providers. However, little is known as to how OPRWs affect the clinician and his or her practice. PURPOSE The purpose of this survey is to evaluate the impact of online physician and provider rating websites on the course of patient care as perceived by orthopedic surgeons and affiliated care providers. STUDY DESIGN/SETTING This is a cross-sectional survey of orthopedic providers. PATIENT SAMPLE A total of 234 local orthopedic surgeons, physiatrists, and physician assistants. OUTCOME MEASURES The frequency of orthopedic surgeons who deviate from their standard practice to elicit a positive patient review. METHODS An electronic, 18-question survey was circulated to 234 local orthopedic surgeons, physiatrist, and physician assistants. Survey results were collected anonymously and statistical analysis was performed on the representative demographic data and categorical responses. Statisticians were blinded to the respondents. RESULTS A total of 92 completed surveys were collected. The median post-training practice duration was 12 (range=0-37) years. Eighty-nine percent stated they were aware of OPRWs, with 60% visiting OPRWs in the past year. Seventeen percent admit to deviating from their standard practice to elicit a positive review while 30% did so to avoid a negative online review. Examples include prescribing additional narcotics, setting arbitrary activity limitations, and ordering unnecessary studies such as an MRI. Only 30% of respondents believe that OPRWs are a valuable resource to help patients select a new physician, while 95% stated that OPRWs failed to fairly and adequately reflect their competency. CONCLUSIONS Orthopedic surgeons and associated providers surveyed in this study are aware of OPRWs and a majority have reviewed their ratings within the past year. An overwhelming majority of respondents indicated that OPRWs are a flawed patient resource, and about a third have attempted to influence their ratings by deviating from their standard practice. These findings suggest that OPRWS indirectly alter patient care in ways that may not be beneficial, have the potential to result in patient harm, and increase health-care costs. Further investigation on this topic is warranted. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

BACKGROUND CONTEXT Thirty percent of Americans have low back pain (LBP) at any given time, leading to approximately 50 million physician visits in the U.S. annually. For patients with chronic low back pain (CLBP), the etiology can be difficult to diagnose and then treat using either current nonsurgical therapies, with inherent patient adherence challenges, or surgical interventions, with associated long recovery times. Antonacci et al, following anatomic study, proposed that a portion of pain previously ascribed to the disc actually emanates from the vertebral body endplate nociceptors which communicate to the central nervous system (CNS) through the basivertebral nerve (BVN). We report on the two-year outcome data of the treatment arm patients in the SMART trial, which studied RF BVN ablation to treat CLBP. PURPOSE To determine the longer term efficacy of basivertebral nerve ablation, for the treatment of chronic low back pain. STUDY DESIGN/SETTING Prospective, randomized, double-blinded, sham control study that was an FDA approved clinical trial. Fifteen sites in the US and three in Germany participated. PATIENT SAMPLE Skeletally mature patients with chronic (>6 months), isolated low back (lumbar) pain and no neurogenic leg pain, who had not responded to at least six months of nonoperative management (conservative care) were eligible for the SMART study. Recent MRI had to demonstrate either Type 1 or 2 Modic changes at three or less contiguous vertebral bodies. OUTCOME MEASURES ODI, Safety, VAS. METHODS A total of 128 patients, from the per-protocol treatment arm of the SMART trial, a double-blind sham-controlled randomized trial, were followed for up to 24 months. ODI and VAS instruments were used to collect patient reported outcomes at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months. RESULTS ODI and VAS data were available on 106 and 104 patients at 24 months respectively. The mean baseline ODI in the treatment arm was 42.4, decreasing to 22.6 at 12 months and 18.8 at 24 months. The mean baseline VAS in the treatment arm was 6.73, decreasing to 3.96 at 12 months and 3.13 at 24 months. Using a paired t -test comparing the 12 and 24-month VAS observations, the mean score at 24 months was significantly improved compared to 12 months (3.80 vs. 3.13, p=.004). CONCLUSIONS The SMART trial demonstrates that BVN ablation is statistically and clinically superior to the sham intervention, and that the degree of ODI improvement is approximately one disability category. Longitudinal follow-up of these patients demonstrates that ablation of the BVN for the relief of CLBP is a durable procedure with continuing improvement in patient reported ODI and VAS scores at up to two years. FDA DEVICE/DRUG STATUS Intracept System (Approved for this indication). [ABSTRACT FROM AUTHOR]