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:
We report the results of six trauma and orthopaedic
projects to Kenya in the last three years. The aims are to deliver both
a trauma service and teaching within two hospitals; one a district
hospital near Mount Kenya in Nanyuki, the other the largest public
hospital in Kenya in Mombasa. The Kenya Orthopaedic Project team
consists of a wide range of multidisciplinary professionals that
allows the experience to be shared across those specialties. A follow-up
clinic is held three months after each mission to review the patients.
To our knowledge there are no reported outcomes in the literature
for similar projects. A total of 211 operations have been performed and 400 patients
seen during the projects. Most cases were fractures of the lower
limb; we have been able to follow up 163 patients (77%) who underwent
surgical treatment. We reflect on the results so far and discuss
potential improvements for future missions.
This study was undertaken to evaluate the safety and efficacy of retrievable inferior vena cava filters in high-risk orthopaedic patients. A total of 58 patients had a retrievable inferior vena cava filter placed as an adjunct to chemical and mechanical prophylaxis, most commonly for a history of previous deep-vein thrombosis or pulmonary embolism, polytrauma, or expected prolonged immobilisation. In total 56 patients (96.6%) had an uncomplicated post-operative course. Two patients (3.4%) died in the peri-operative period for unrelated reasons. Of the 56 surviving patients, 50 (89%) were available for follow-up. A total of 32 filters (64%) were removed without complication at a mean of 37.8 days (4 to 238) after placement. There were four filters (8%) which were retained because of thrombosis at the filter site, and four (8%) were retained because of incorporation of the filter into the wall of the inferior vena cava. In ten cases (20%) the retrievable filter was left in place to continue as primary prophylaxis. No patient had post-removal thromboembolic complications. A retrievable inferior vena cava filter, as an adjunct to chemical and mechanical prophylaxis, was a safe and effective means of reducing the acute risk of pulmonary embolism in this high-risk group of patients. Although most filters were removed without complications, thereby avoiding the long-term complications that have plagued permanent indwelling filters, a relatively high percentage of filters had to be left
