Pre-clinical evaluation of therapies to prevent or treat bone non-union: a systematic review protocol

BACKGROUND: Non-union of fractured bone is a major cause of morbidity in the orthopaedic population. Despite this, optimal management of non-union is still unclear and remains a significant clinical challenge. Research continues in animal models in an attempt to identify an effective clinical treatment. The proposed systematic review will evaluate current therapies of bone non-union in animal models, in order to identify those that may translate successfully to clinical therapies.

METHODS/DESIGN: The methodology for the systematic review will be in accordance with standard guidelines. All potential sources for pre-clinical studies will be interrogated and the search strategy written in conjunction with a specialist in this field. Data extraction will be conducted by two reviewers to minimise bias. Analysis will be predominantly qualitative because of the heterogeneity that is likely to exist between the studies. However, quantitative synthesis will be performed where homogeneity in a sub-group of studies exists. Quality assessment will be undertaken utilising a risk of bias tool.

DISCUSSION: To date, there has not been a systematic review addressing bone non-union therapies in animal models despite the plethora of pre-clinical research currently being undertaken. This protocol details and outlines the methodology and justification for such a review.