RANDOMISED CONTROL TRIAL

Ethical Theories and Principles on RCT of an Intra-medullary Nail versus Dynamic Screw and Plate for Inter-trochanteric Fractures of the Femur



Ethical Theories and Principles on RCT of an Intramedullary Nail versus Dynamic Screw and Plate for Intertrochanteric Fractures of the Femur

Introduction

Randomized controlled trial (RCT) is a specialised experiment and analysing system that is preferred in case of a clinical trial. RCT when planned and conducted properly provide the best evidence of the effectiveness of Interventions health. However trials that involve an inadequate methodological approach are associated with an overestimation of treatment effects (Neyman, 1990, 465). The research paper selected for the purpose of systematic review and implication of ethical theories and principles on randomised control trial is “Prospective Randomized Controlled Trial of an Intramedullary Nail Versus Dynamic Screw and Plate for Intertrochanteric Fractures of the Femur” which is written by Christopher I. Adams, C. Michael Robinson, Charles M. Court-Brown, and Margaret M. McQueen. The purpose of this paper is to critically analyse ethical theories and principles and demonstrate a critical understanding of how these inform ethical reasoning in RTC.

Introduction to the Research Study

Summary

This research paper aims to compare the surgical complications and functional outcomes of the Gamma nail intramedullary fixation device versus the Richards sliding hip screw and plate device in intertrochanteric femoral fractures. The research was conducted in a hospital of the United Kingdom during the time duration from 1994 to 1995. 400 participants were selected randomly as part of the random trial as patients with intertrochanteric fracture. Two types of fixing devices for the fracture treatment were used, which include; Gamma nail intramedullary fixation device versus the Richards sliding hip screw and plate device. The research showed that these methods had still high probability of risk, however these risks are non significant.

Aims

The research paper aims to find out which method has higher probability of suitable outcomes while treating the patients of intertrochanteric femoral fractures. Two types of fixing devices for the fracture treatment were used, which include; Gamma nail intramedullary fixation device versus the Richards sliding hip screw and plate device.

Research Question

What are the ethical theories and principles of an Intramedullary Nail Versus Dynamic Screw and Plate for Intertrochanteric Fractures of the Femur?

Is the use of an intramedullary device in the treatment of intertrochanteric femoral fractures still associated with a higher but non significant risk of postoperative complications?

Sample Group

The sample group for this study comprises of 400 patients. Random samples reduce the possibility of their differences (for example, age, sex, race, weight, and hair colour or disease risk) between two random groups, provided that the groups are large enough to produce groups statistically stable. These patients included 203 participants for Gamma nail and 197 participants for Richard's type sliding hip screw and plate.

Methodology

The research design includes the given primary data taken randomly from a sum of 400 patients with intertrochanteric fracture. Also, there is the use of reliable electronic data from their sources with sociological settings. Gathering all of this information was a yard ...