Objectives. The purpose of this study was to evaluate in vivo biocompatibility
of novel single-walled carbon nanotubes (SWCNT)/poly(lactic-co-glycolic
acid) (PLAGA) composites for applications in bone and tissue regeneration. Methods. A total of 60 Sprague-Dawley rats (125 g to 149 g) were implanted
subcutaneously with SWCNT/PLAGA composites (10 mg SWCNT and 1gm
PLAGA 12 mm diameter two-dimensional disks), and at two, four, eight
and 12 weeks post-implantation were compared with control (Sham)
and PLAGA (five rats per group/point in time). Rats were observed
for signs of morbidity, overt toxicity, weight gain and food consumption,
while haematology, urinalysis and histopathology were completed
when the animals were killed. Results. No
High-quality randomised controlled trials (RCTs)
evaluating surgical therapies are fundamental to the delivery of
evidence-based orthopaedics. Orthopaedic clinical trials have unique
challenges; however, when these challenges are overcome, evidence
from trials can be definitive in its impact on surgical practice.
In this review, we highlight several issues that pose potential
challenges to orthopaedic investigators aiming to perform surgical randomised
controlled trials. We begin with a discussion on trial design issues,
including the ethics of sham surgery, the importance of sample size,
the need for patient-important outcomes, and overcoming expertise
bias. We then explore features surrounding the execution of surgical
randomised trials, including ethics review boards, the importance
of organisational frameworks, and obtaining adequate funding. Cite this article:
