Design of Lamifuse: a randomised, multi-centre controlled trial comparing laminectomy without or with dorsal fusion for cervical myeloradiculopathy

Contains fulltext : 52342.pdf ( ) (Open Access)BACKGROUND: laminectomy is a valuable surgical treatment for some patients with a cervical radiculomyelopathy due to cervical spinal stenosis. More recently attention has been given to motion of the spinal cord over spondylotic spurs as a cause of myelopathic changes. Immobilisation by fusion could have a positive effect on the recovery of myelopathic signs or changes. This has never been investigated in a prospective, randomised trial. Lamifuse is an acronyme for laminectomy and fusion. METHODS/DESIGN: Lamifuse is a multicentre, randomised controlled trial comparing laminectomy with and without fusion in patients with a symptomatic cervical canal stenosis. The study population will be enrolled from patients that are 60 years or older with myelopathic signs and/or symptoms due to a cervical canal stenosis. A kyphotis shape of the cervical spine is an exclusion criterium. Each treatment arm needs 30 patients. DISCUSSION: This study will contribute to the discussion whether additional fusion after a cervical laminectomy results in a better clinical outcome. ISRCT NUMBER: ISRCTN72800446

External validation of a model to predict the survival of patients presenting with a spinal epidural metastasis

The surgical treatment of spinal metastases is evolving. The major problem is the selection of patients who may benefit from surgical treatment. One of the criteria is an expected survival of at least 3 months. A prediction model has been previously developed. The present study has been performed in order to validate externally the model and to demonstrate that this model can be generalized to other institutions and other countries than the Netherlands. Data of 356 patients from five centers in Germany, Spain, Sweden, and the Netherlands who were treated for metastatic epidural spinal cord compression were collected. Hazard ratios in the test population corresponded with those of the developmental population. However, the observed and the expected survival were different. Analysis revealed that the baseline hazard function was significantly different. This tempted us to combine the data and develop a new prediction model. Estimating iteratively, a baseline hazard was composed. An adapted prediction model is presented. External validation of a prediction model revealed a difference in expected survival, although the relative contribution of the specific hazard ratios was the same as in the developmental population. This study emphasized the need to check the baseline hazard function in external validation. A new model has been developed using an estimated baseline hazar

Design of the PROCON trial: a prospective, randomized multi – center study comparing cervical anterior discectomy without fusion, with fusion or with arthroplasty

BACKGROUND: PROCON was designed to assess the clinical outcome, development of adjacent disc disease and costs of cervical anterior discectomy without fusion, with fusion using a stand alone cage and implantation of a Bryan's disc prosthesis. Description of rationale and design of PROCON trial and discussion of its strengths and limitations. METHODS/DESIGN: Since proof justifying the use of implants or arthroplasty after cervical anterior discectomy is lacking, PROCON was designed. PROCON is a multicenter, randomized controlled trial comparing cervical anterior discectomy without fusion, with fusion with a stand alone cage or with implantation of a disc. The study population will be enrolled from patients with a single level cervical disc disease without myelopathic signs. Each treatment arm will need 90 patients. The patients will be followed for a minimum of five years, with visits scheduled at 6 weeks, 3 months, 12 months, and then yearly. At one year postoperatively, clinical outcome and self reported outcomes will be evaluated. At five years, the development of adjacent disc disease will be investigated. DISCUSSION: The results of this study will contribute to the discussion whether additional fusion or arthroplasty is needed and cost effective. TRIAL REGISTRATION: Current Controlled Trials ISRCTN4168184

Line from the posterior inferior part of the vertebral body of C2 to the posterior superior part o f the vertebral body of C7 in case of a normal cervical lordotic curvature (A) and a kyphotic cervical curve (B)

<p><b>Copyright information:</b></p><p>Taken from "Design of Lamifuse: a randomised, multi-centre controlled trial comparing laminectomy without or with dorsal fusion for cervical myeloradiculopathy"</p><p>http://www.biomedcentral.com/1471-2474/8/111</p><p>BMC Musculoskeletal Disorders 2007;8():111-111.</p><p>Published online 9 Nov 2007</p><p>PMCID:PMC2194678.</p><p></p

Caseload as a factor for outcome in aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis

Contains fulltext : 127545.pdf (publisher's version ) (Open Access)Object Increasing evidence exists that treatment of complex medical conditions in high-volume centers is found to improve outcome. Patients with subarachnoid hemorrhage (SAH), a complex disease, probably also benefit from treatment at a high-volume center. The authors aimed to determine, based on published literature, whether a higher hospital caseload is associated with improved outcomes of patients undergoing treatment after aneurysmal subarachnoid hemorrhage. Methods The authors identified studies from MEDLINE, Embase, and the Cochrane Library up to September 28, 2012, that evaluated outcome in high-volume versus low-volume centers in patients with SAH who were treated by either clipping or endovascular coiling. No language restrictions were set. The compared outcome measure was in-hospital mortality. Mortality in studies was pooled in a random effects meta-analysis. Study quality was reported according to the GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria. Results Four articles were included in this analysis, representing 36,600 patients. The quality of studies was graded low in 3 and very low in 1. Meta-analysis using a random effects model showed a decrease in hospital mortality (OR 0.77 [95% CI 0.60-0.97]; p = 0.00; I(2) = 91%) in high-volume hospitals treating SAH patients. Sensitivity analysis revealed the relative weight of the 1 low-quality study. Removal of the study with very low quality increased the effect size of the meta-analysis to an OR of 0.68 (95% CI 0.56-0.84; p = 0.00; I(2) = 86%). The definition of hospital volume differed among studies. Cutoffs and dichotomizations were used as well as division in quartiles. In 1 study, low volume was defined as 9 or fewer patients yearly, whereas in another it was defined as fewer than 30 patients yearly. Similarly, 1 study defined high volume as more than 20 patients annually, and another defined it as more than 50 patients a year. For comparability between studies, recalculation was done with dichotomized data if available. Cross et al., 2003 (low volume /= 19) and Johnston, 2000 (low volume /= 32) provided core data for recalculation. The overall results of this analysis revealed an OR of 0.85 (95% CI 0.72-0.99; p = 0.00; I(2) = 87%). Conclusions Despite the shortcomings of this study, the mortality rate was lower in hospitals with a larger caseload. Limitations of the meta-analysis are the not uniform cutoff values and uncertainty about case mix

Smoking intensity and bladder cancer aggressiveness at diagnosis.

To explore the relation between cigarette smoking intensity and bladder cancer aggressiveness at first diagnosis.Patients diagnosed with urinary bladder cancer (BC) between 1995-2011 under the age of 75 years were retrospectively identified from the Netherlands Cancer Registry and invited for a study on genetic and lifestyle risk factors for BC. Information on patients' self-reported smoking history was retrieved by means of a postal questionnaire. Tumors were stratified regarding the risk of progression defined by tumor stage and grade. Multinomial logistic regression was used to analyze the relation between smoking intensity and aggressiveness of the tumor.The UBC study population comprised 323 (17.4%) never smokers, 870 (46.8%) former cigarette smokers, and 630 (33.9%) current cigarette smokers. A higher smoking amount was a risk factor of getting high-risk non-muscle invasive bladder cancer (NMIBC) compared with low-risk NMIBC in ever and former cigarette smokers (OR: 1.02 per cigarette smoked, 95% CI: 1.00-1.03 and OR: 1.03, 95% CI: 1.01-1.05, respectively). A statistically significant dose-response increase in the risk of a more aggressive cancer type (high-risk NMIBC and MIBC) was observed with increasing smoking duration among former smokers (p for trend 0.035 and 0.008, respectively). No significant association of the evaluated smoking intensity variables was observed in current smokers. A longer time of smoking cessation correlated with a lower odds of a more aggressive cancer.We observed a weak increase in the risk of a more aggressive tumor type with increasing smoking intensity in former smokers, but this association was absent in current smokers. This conflicting result may suggest that there is no strong relation between smoking intensity and bladder cancer aggressiveness. Analyses of prospective studies with longitudinal smoking assessment may provide a more definitive answer to the research question