Osteoarthritis, Knee Clinical Trial
Official title:
Prospective Observational Study of Current Perioperative Care for Hip and Knee Arthroplasty in South Africa, and Associated Outcomes
This multi-site, observational, prospective study aims to investigate current practice and associated outcomes for patients scheduled for elective unilateral total hip or knee arthroplasty in South Africa.This information will provide baseline values, against which effects of implementing a multidisciplinary enhanced care protocol for arthroplasty patients will be compared (the subsequent study).
RESEARCH PROBLEM:
In the past 20 years, enhanced recovery pathways (ERPs) have become increasingly integrated
into most surgical fields as standard care in high income countries, as is exemplified by
national priority programs and the widespread acceptance of the Enhanced Recovery After
Surgery (ERAS) society network. ERPs represent a fundamental shift towards a patient-centred,
multidisciplinary-driven continuity of care that aim to attenuate surgical stress and
expedite recovery. Studies on total joint arthroplasty (TJA) for both hips and knees have
shown that implementation of an evidence-based, structured approach to patient care decreases
postoperative morbidity and consequently length of stay without increasing readmission rate.
However, in low- and middle-income countries, the value of implementing ERPs is yet to be
explored. This may be because: i) the perception that current hospital resources may make it
difficult to develop and implement structured and sustainable protocols to enhance
postoperative recovery, and ii) short and long-term data collection on the quality of the
work provided is scarce, inhibiting the ability to benchmark clinical results and improve the
service provided to patients. Despite these challenges, a healthcare system in a
middle-income country such as South Africa may benefit from the implementation of ERPs
through reduced postoperative morbidity and the associated cost reductions, as has been
demonstrated in high-income countries.
STUDY RATIONAL:
Documentation of current perioperative interventions with associated postoperative outcomes
is crucial before implementing a new model for perioperative care. As such, this study will
give the investigators baseline values against which the perioperative results achieved from
instituting a multidisciplinary enhanced care programme for South African arthroplasty
patients will be analyzed.
STUDY DESIGN:
This is a 10-week prospective observational audit of patients scheduled for primary elective
unilateral total hip or knee arthroplasty at 9 District, Regional and Central hospitals in
South Africa.
PATIENT RECRUITMENT, DATA COLLECTION AND CONFIDENTIALITY:
The patients will be recruited consecutively by the orthopaedic surgeons in the preoperative
arthroplasty clinic or when presenting for admission before surgery (minimum 1 day before
surgery). Staff from the departments of orthopaedic surgery, physiotherapy and anaesthesia
will be responsible for in-hospital data capture. Telephonic follow-up interviews 30 days and
12 months after surgery will be conducted by the Principal Investigator or dedicated research
assistants. The patients will be informed that they can choose to leave the study at any time
during the study period.
Each individual center will collect and record data on either an electronic or paper case
record form (CRF) for every patient recruited. Access to the data entry system will be
protected by username and password delivered during the registration process for individual
local investigators. All electronic data transfer between participating centres and the
coordinating center will be encrypted using a secure protocol (HTTPS/SSL 3.0 or better).
TIME FRAME:
The study will run for 10 weeks at each enrolled site. The in-hospital and 30 day data
collection is expected to be completed in 2018.
RISK AND BENEFITS:
Participation in the study will not add any risk to the patient, why the patient's safety is
intact. Principles of Helsinki and Good Clinical Practice will be adhered to.
SAMPLE SIZE CALCULATION AND STATISTICAL ANALYSIS:
As knowledge on current postoperative outcomes after hip and knee arthroplasty in South
Africa is scarce, this study is a descriptive hypothesis generating study to establish
baseline data for future studies, and hence there is no formal power calculation for this
study's primary outcome; Days alive and at home 30 days after surgery (DAH30). However, in
the study by Myles and colleagues (Myles et al. BMJ Open. 2017; 7(8): e015828. Published
online 2017 Aug 18. doi: 10.1136/bmjopen-2017-015828) patient cohorts of approximately 200
patients resulted in clinically relevant and acceptable 95% CI, why we aim to enrol minimum
200 patients. The data are expected to be non-parametric and will be presented as median with
interquartile range (25-75 percentile).
As the investigators are unaware of any publications of South African orthopaedic patients
which report the specified secondary outcomes, the data will be used to establish a baseline
incidence in South African arthroplasty patients for HRQoL (preoperative, 30 days and 12
months postoperative), TUG (in-hospital day 3), mortality (12 months postoperative) and
prosthetic joint infection and joint revision (12 months postoperative). These data will be
used to power future interventional studies.
Continuous variables will be described using sample mean and standard deviation (SD) and
categorical variables using sample median and interquartile range (IQR). Where statistical
comparisons are to be made between continuous variables, the unpaired t-test or Mann Whitney
U test will be used as appropriate. Categorical data will be compared using the χ2 test.
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