Clinical Trials in Low Volume Orthopaedic Surgery: management of unreconstructible distal humerus fractures

Multi-fragment intra-articular distal humerus fractures in adults are treated with elbow replacement when surgery is indicated, there are no serious co-morbidities, and where the elbow fracture cannot be treated with plates and screws. It is not clear if patients should be treated with replacement of both sides of the elbow, total elbow replacement (TER), or just replacement of the broken humeral part, distal humerus hemi-replacement (DHH). This type of injury has very low incidence and that poses questions about the best methods to evaluate the different surgical procedures. The overall aim of this thesis is to explore outcomes that could be used in a clinical trial of low volume surgical procedures of the management of acute unreconstructible distal humerus fractures in adults. A scoping review was conducted to map the outcomes, trial methods and funding sources used for elbow replacement research. There were 362 published studies identified that reported 583 outcomes. A real-time Delphi study identified 9 mandatory core domains for elbow replacement that should be used in future research, and patients identified pain as the most important outcome domain for them. A systematic review of the literature on pain outcomes following elbow replacement for trauma found that there may be differences in the distribution of pain outcomes from TER and DHH, but direct comparison could not be made because the outcome instruments were not validated for elbow replacement and the quality of included studies was low. The patient rated elbow evaluation is the only pain instrument validated for use in elbow replacement that captures the frequency of pain. An expert elicitation study was conducted to produced prior probability density functions of the likely difference in pain outcomes for a comparative randomised trial of TER and DHH in adult acute distal humerus fracture, using this pain instrument.