RESUMO
BACKGROUND: One of the great challenges in the management of open fractures is postoperative infection with a higher incidence in Gustilo-Anderson type III fractures. Definitive management of such fractures in developing countries is usually with external fixators with its attendant complications such as deep fracture-related infection, non-union, and consequent increased re-operation rates. Recently, there has been a novel method of using antibiotic-cement coated implants such as intramedullary nails and locking plates in the treatment of infected non-unions with reported excellent outcomes. This protocol aims to describe the hypothesis, objectives, design and statistical analysis of a randomized control trial that compares the infection rate between the use of antibiotics-cement coated plate and external fixation in the management of Gustilo-Anderson type III long bone fractures. METHODS: This is a multicentre, open-label, parallel group, superiority, randomized, control trial. All patients with type III long bone fractures who present at the emergency department will be screened for enrolment and only those patients that meet the inclusion criteria will be registered for the study. Patients will be randomized using a centralized 24-hr computerized randomization system into two groups: antibiotic-cement coated plate group and the external fixation group. The primary outcome will be occurrence of infection at any time during the course of one year follow-up which will be counted once for each of the patients. The secondary outcomes are union rate, re-operation rate and change in Health Related Quality of Life (HRQoL) from baseline to end of follow-up. Analysis will be done using R (R Core Team, 2023) and Rstudio (Rstudio Team, 2023). DISCUSSION: Literature has shown that use of antibiotic-coated plate in the management of severe open long bone fractures is effective in reducing infection rate. A significant difference in infection rate with use of antibiotic-cement coated plate compared to use of external fixator for open fractures will be a welcome intervention in developing countries. TRIAL REGISTRATION: The study protocol is registered with ClinicalTrials,gov (NCT06193330).
RESUMO
The Q-angle has been studied among the adult Caucasian population with the establishment of reference values. Scientists are beginning to accept the concept of different human races. Physical variability exists between various African ethnic groups and Caucasians as exemplified by differences in anatomic features such as a flat nose compared with a pointed nose, wide rather than narrow faces, and straight rather than curly hair. Therefore, we cannot assume the same Q-angle values will be applicable to Africans and Caucasians. We established a baseline reference value for normal Q-angles among asymptomatic Nigerian adults. The Q-angles of the left and right knees were measured using a goniometer in 477 Nigerian adults (354 males; 123 females) in the supine and standing positions. The mean Q-angles for men were 10.7 degrees +/- 2.2 degrees in the supine position and 12.3 degrees +/- 2.2 degrees in the standing position in the right knee. The left knee Q-angles in men were 10.5 degrees +/- 2.6 degrees in the supine position and 11.7 degrees +/- 2.8 degrees in the standing position. In women, the mean Q-angles for the right knee were 21 degrees +/- 4.8 degrees in the supine position and 22.8 degrees +/- 4.7 degrees in the standing position. The mean Q-angles for the left knee in women were 20.9 degrees +/- 4.6 degrees in the supine position and 22.7 degrees +/- 4.6 degrees in the standing position. We observed a difference in Q-angles in the supine and standing positions for all participants. The Q-angle in adult Nigerian men is comparable to that of adult Caucasian men, but the Q-angle of Nigerian women is greater than that of their Caucasian counterparts.
