Author's reply

Sir,

We thank the authors of the letter¹ for showing keen interest in our article, “Comparative study of single lateral locked plating versus double plating in type C bicondylar tibial plateau fractures.”²

We do accept the considerations highlighted by them, saying it is observational study with inherent lacuna. We agree that randomized controlled trials (RCTs) are the most rigorous method of determining whether a cause and effect relationship exists between treatment and outcome. However, most surgical research takes the form of retrospective case series, often with a small number of patients.² Furthermore, surgical treatments are half as likely to be based on RCT evidence, than are medical therapies.³ There is debate about the feasibility of RCTs for surgical interventions and the superiority of RCTs over non-RCTs or observational designs.³ In reality, experimental and observational studies contribute complementary evidence. It is important to recognize the value of evidence from non-RCTs evaluating surgical interventions when the conduct of RCTs is impractical or unethical. However, we acknowledge that even in these situations, conclusions drawn from observational studies must be interpreted with caution. The internal validity of surgical trials is often lower than drug trials because the outcomes are dependent on the characteristics of the participating surgeons and settings.³ Drug trials risk less differential bias in administering an active drug versus placebo to patients; however, surgery is a skilled, multistep process, and this makes the design of RCTs more challenging.

There is a learning process for every new surgical technique, even for a fully trained surgeon. It is during the learning curve process that errors and adverse events are more likely to occur; therefore, treatment of patients between an expert surgeon and one with restricted expertise can compromise the validity of the study.³,⁴ Surgeons are more likely to participate in expertise-based trials because they have the choice of performing their preferred treatment.⁴ We agree that differences in methods, skills, and experiences of operative teams (residents, nurses, etc.) in each case can introduce further variation. Examining each of this variable influencing surgery is not practical. We wanted to highlight the results we had seen during the course of our study. It is a relatively big study with big numbers not much in literature and hence can be a valid source of information for the readers of the journal which can be exemplified by the fact that it is the most read and downloaded article of the issue. Finally, our paper is not that the last word about treatment of tibial plateau fractures has been said and we would definitely like to see in future, RCTs published on this subject.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflict of interest.