Computational protocol: Tenotomy versus Tenodesis in the treatment of the long head of biceps brachii tendon lesions

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Protocol publication

[…] Patients will be recruited from the outpatient clinic. The goal is to assess 128 participants for the study. We performed a priori power analysis to determine the sample size required to achieve the pre-specified power level (1 - β), significance level α, and the population effect size for the CMS between the two treatment groups to be assessed. In a previous study, the CMS was normally distributed within some subject groups []; therefore, we will use an unpaired t-test with an associated medium effect size equal to 0.5. Under these conditions, we will need to study 64 subjects for each group to be able to reject the null hypothesis that the population means of the groups are equal with a probability (power) of 0.8 and that the Type I error probability is equal to 0.05. Considering the same significance and power level, this sample size will allow us to detect an effect size that is equal to 0.35 for the null hypothesis that the population means of CMS scores before and after treatment are equal. Because of the possibility that participants could drop out of the protocol, a total of 150 patients will be recruited for the trial. G*Power software (Institut fur Experimentelle Psychologie, Heinrich Heine Universitat, Dusseldorf, Germany) was used for the power analyses. [...] The mean, standard deviation and range will be reported for the continuous variables (symptom duration, CMS and SF-36 scores), whereas counts will be used to describe the categorical variables (gender, dominant arm, surgical side, concomitant injuries, disease onset, prior conservative therapies, shoulder tests, surgical technique, cramping, surgical complications, medication usage). Discrete variables will also be analyzed (activity level, LHBT condition). A determination of whether the CMS and SF-36 absolute and percent changes from baseline can reasonably be modeled using Gaussian theory will be performed by examining normal probability plots.Mean CMS and SF-36 scores will be compared between and within treatment groups at each follow-up using repeated measure analysis of variance (ANOVA) methods on the appropriate scale. The chi-squared test will be used for the comparison of binary measures. If a parametric analysis is feasible, t-tests will be used for the comparison of continuous measures. If the Gaussian model is not appropriate, non-parametric comparison methods will be used on medians, as well as means. In particular, the Mann–Whitney U-test will be used to assess the difference in score distribution between the groups, whereas the Wilcoxon test will be used to compare the scores within the group. The percent of dropouts over time will also be compared in each treatment group. Complications will be compared by treatment group using exact chi-squared methods. Confidence intervals will be reported for the incidence of complications. Age-weighted univariate and multiple stepwise linear and logistic regression analyses will be used to evaluate the relationships between explanatory variables and outcomes with continuous and categorical distributions, respectively. Only explanatory and confounding variables that show a trend toward an association with the outcome of interest (e.g., p < 0.10) in the univariate analysis will be inserted into these models. In the multiple linear regression analysis, total adjusted R2 for the model and changes in R2 for the independent contribution of single predictors will be calculated to assess the total variance in the outcome variable accounted for by the whole model and single explanatory variables, respectively. In the case of collinearity between the explanatory variables, only the best-fitting models (e.g., those including the collinear explanatory variable accounting for the most relevant variation in the variance of the outcome) will be adopted. A P value of less than 0.05 will be considered significant. The SPSS (SPSS Statistics 17.0, Inc., Chicago, IL, USA) software program for Windows will be used for the database and statistical analysis. […]

Pipeline specifications

Software tools G*Power, SPSS
Application Miscellaneous
Organisms Homo sapiens
Diseases Brain Diseases, Tendinopathy