Research in trauma surgery: from design to execution: The construction of an RCT and methodological considerations

Abstract

Ankle fractures are the most common lower extremity fractures. The main causes of ankle fractures are minor trauma and sports, which are typical injuries for individuals in their working age. As such, ankle fractures have high impact on both individual patients and society. Due to the occupational disability in the population at risk, ankle fractures are associated with loss of productivity and high costs for society. The disability after ankle fractures and the resulting personal and economic burden emphasize the importance of a safe and rapid functional recovery. Functional recovery of patients with operatively treated ankle fractures is highly impacted by the postoperative treatment regimen. Although indications for surgical fixation are widely accepted, controversy exists regarding the postoperative treatment of ankle fractures. The aim of this thesis was to identify the most optimal postoperative treatment of ankle fractures. A wide range of postoperative treatment regimens have been used, ranging from immobilization in a plaster cast without weight-bearing for multiple weeks to immediate post-operative unprotected mobilization. In the investigation for the best suitable postoperative treatment regimen of ankle fractures, patient selection and fracture identification need to be accounted for. For example, certain patients are at risk for complications and thereby studies can be affected by the in- or exclusion of those patient groups. The postoperative care regime did not influence the most relevant complications (wound- and implant related complications). In addition, we have shown that different trauma mechanisms cause different fracture types, each requiring their own distinct approach. Unprotected weight-bearing and mobilization as tolerated as postoperative care regimen improved short-term functional outcomes and led to earlier return to work and sports, yet did not result in an increase of complications in adult patients without comorbidities who suffered a supination external rotation type 2 to 4 ankle fracture. The secondary objective of this thesis was to evaluate the value of observational studies in trauma surgery research. Using ankle fractures, the transition in trauma surgery research has been described. Besides the evolution of postoperative treatment regimens to early mobilization and early weight-bearing, studies investigating this topic have changed in the past decades. Both the type of studies and outcomes have changed. Fewer randomized controlled trials (RCTs) have been published, while the total number of published studies has increased. Strikingly, the quality of the published articles has not declined. One of the most remarkable progressions to a tailor-made treatment is the gradual shift from physician measured to patient reported outcome measures. Observational studies can complement systematic reviews and meta-analyses of randomized trials in clinical queries as the power can be increased and results between observational studies and RCTs are sometimes comparable. High quality observational studies (good constructed and well performed) might play a greater role in future research. If rare events need to be identified, large (observational) databases are needed to identify these cases. The use of quality assessment tools can be of assistance in improving both methodological and reporting quality of these (surgical) studies to ensure reproducibility.