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Total knee arthroplasty with comparison of inset versus onlay patella replacement: investigation of anterior knee pain and function.
Expand descriptionThe aim of this trial is to compare current patella component designs (inset vs onlay), with the hope of finding significant improvement in anterior knee pain or knee function for one design over the other. Subsequently, future patients can benefit from surgery using the superior design. This trial will recruit suitable and consenting participants from the private rooms of Prof. D Wood at the Perth Orthopaedic Institute, HPH. Consenting participants would undergo a total knee arthroplasty (which they otherwise would undergo, whether they were enrolled in this study or not, as part of their clinical care). The patella component of their total knee arthroplasty (TKA) will be randomised to either an inset design or onlay design. All surgeries will be carried out by Prof. D Wood using his routine surgical technique and peri-operative care. Participants are not placed at increased risk or offered inferior treatment in this study based on current knowledge. Participants will have standard postoperative weekly physiotherapy sessions as part of the standard care following total knee arthroplasty, and will be followed up by Prof Wood at 3, 6, 12, 24 and 60 months, also as part of usual care. During this interval follow up, participants will also complete a series of validated scoring questionnaires and functional tests, administered by a trained assessor. These functional data will be compared across the two study groups (inset patella component, onlay patella component) and hazard ratios and confidence intervals generated using statistical software. Anonymous results will be submitted for publication in a leading orthopaedic journal to inform other surgeons and medical professionals of the results.
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Trauma-Focused Cognitive Behavioural Therapy (CBT) and Exercise for Chronic Whiplash
Expand descriptionThe primary aim of this project is to investigate the effectiveness of combined trauma-focused CBT and exercise to decrease pain and disability of individuals with chronic whiplash and PTSD. The secondary aims are to investigate the effectiveness of combined trauma-focused CBT and exercise to decrease posttraumatic stress symptoms, anxiety and depression, and to investigate the effectiveness of trauma-focused CBT alone on posttraumatic stress symptoms and pain/disability. For individuals with chronic whiplash and posttraumatic stress, it is hypothesised that: 1. Trauma-focused CBT followed by a physiotherapy exercise program will result in significantly greater improvements in pain and disability up to 12 months post treatment compared with supported counselling followed by a physiotherapy exercise program. 2. Trauma-focused CBT followed by a physiotherapy exercise program will result in significantly greater improvements in posttraumatic stress symptoms, anxiety and depression up to 12months post treatment compared with supported counselling and a physiotherapy exercise program. 3. An initial treatment of trauma-focused CBT will result in significantly greater improvements in pain/disability, posttraumatic stress symptoms, anxiety and depression immediately post-treatment compared with a supported counselling intervention.
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Mapping of Atrial Arrhythmias Using High Spatial Resolution Mapping Catheters and the Rhythmia Mapping System
Expand descriptionActivation, Entrainment and Pace mapping techniques has been the mainstay of the catheter based mapping and ablation of all atrial arrhythmias. The original studies describing these mapping techniques were performed almost two decades ago. These studies were performed using fluoroscopy alone without the aid of a 3D electroanatomical mapping system. Indeed all published mapping and entrainment studies have been performed using catheters with a large (4mm or 8mm) distal tip of the roving mapping catheter. These studies are yet to be repeated using the newly available catheter technology. Indeed there is no data on the accuracy of activation, entrainment and pace mapping using these ‘new generation’ of mapping catheters with small micro electrodes and narrow bipolar spacing. Hence the aim of this study is to perform detailed activation, entrainment and pace mapping in a variety of atrial arrhythmias in order to validate the classical mapping criteria and techniques using these new catheters.
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Identification of biomarkers that correlate with clinical features and outcomes following concussion
Expand descriptionThis is a study of patients presenting to the Emergency Department (ED) with concussion. Clinical data, imaging, neuropsychological testing and blood samples of patients with concussion will be correlated with outcomes. This may lead to the development of improved tools for diagnosis and prognosis, which could be used in future trials of treatment for concussion.
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Comparison of low-chemical elimination diet with a low fermentable oligo, di, mono-saccharide and polyol (low FODMAP) diet for the management of functional gastrointestinal disorders (FGID)
Expand descriptionThe aim is to compare the effectiveness of two widely used diets: (1) the RPAH low chemical elimination diet, and (2) the low FODMAP diet. Patients will be randomly allocated to a 3-week period on one of these diets, after which they will cross-over for a further 3 weeks on the other diet. The main outcome measure will be symptom response. In addition to keeping a standard daily food & symptom diary, participants will be asked to complete questionnaires before, during and after the intervention period to assess impact on quality of life. Their dietary intake will also be analysed by a dietitian to ensure ongoing nutritional adequacy.
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TEMP-T study: cognitive aids for airway cart set-up in preparation for emergency intubation.
Expand descriptionThe study is a prospective randomized controlled study. The study is designed as a paper-based intervention of senior medical and nursing staff working in the resuscitation room environment in the Emergency Department of The Royal Childrens Hospital. The study is single centred. The study is designed to assess the utility of paper-based interventions (checklist or template) in standardizing airway trolley set-up compared to no intervention. As a randomized controlled study, the primary study objective should be free of bias. Data collected will include the participant role (medical or nursing) and level of seniority. Additionally, study information will include the rate of omitted items from airway trolley set-up, the error rate in airway trolley set-up, the time taken to set up the airway trolley, and staff confidence and satisfaction with airway trolley set-up. A photo of the airway trolley set up will be recorded for blinded assessment of variability in equipment location. No identifiable information will be recorded at any stage of the investigation. Data will be collected during the participant encounter for omission rate, error rate, and satisfaction / confidence survey. This data will be recorded on a standardized Clinician Report Form (CRF). This will be stored in a locked study cabinet accessible only to the primary investigator. A photograph of the airway trolley set-up will be taken with a dedicated digital camera at the time of participant encounter for later analysis. This will be stored on a password protected external hard drive. Study preparation and planning will take approximately 2 months. Participant recruitment, based on a total number of participants of 63 with 7 study investigators recruiting 3-5 participants per week, will take approximately 1 month. Data collection and analysis will take approximately 2-3 months.
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Efficacy of Dexamethasone in reducing pain, nausea and vomiting, improve mobilisation and reduce hospital stay in hip and knee arthroplasty: a double blind controlled trial
Expand descriptionThe purpose of this study is to determine if steroids used at the time of surgery reduce pain, nausea and vomiting, and reduce length of stay in patients undergoing total hip or knee arthroplasty procedures.
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Feasibility study of the Drug Burden Index with Home Medicine Review
Expand descriptionThe proportion of older Australians is increasing, in parallel to increasing multimorbidity, polypharmacy and an increased risk of Adverse Drug Events (ADEs). The Drug Burden Index (DBI) is a pharmacologic risk assessment tool that measures an individual’s total exposure to anticholinergic and sedative medications. A high DBI score is associated with poor clinical outcomes in older adults. Home Medicines Review (HMR) is a comprehensive medication review service involving a pharmacist, general practitioner (GP) and the patient with the aim of enhancing quality use of medicines and reducing ADEs. To date, the DBI has not been tested in the HMR setting. AIMS: (1) To assess if the DBI report is feasible as a risk assessment tool in this setting; (2) To establish whether the DBI together with HMR service can reduce use of anticholinergic and sedative medications in older adults; (3) To assess changes in clinical outcomes in older adults following reduction of anticholinergic and sedative medications. Methods: An interventional feasibility study with two arms will be conducted: 10-20 pharmacists, who regularly conduct HMRs in the community, will be recruited to participate in the study. Each pharmacist will undergo an education program and be provided access to the Drug Burden Index Calculator 'Copyright'. Each pharmacist will also provide anonymous data on HMRs conducted for 10 patients to serve as historical controls. The intervention will involve pharmacists providing a DBI report to GPs with the HMR service for 10 patients. Patients will be asked to fill in a questionnaire, and be contacted by telephone for an interview at 0 and 3 months (post-HMR) by lead investigator to assess cognition and physical function. Discussion: Results from this study will provide an evaluation of the utility of the DBI as a risk assessment tool for reducing inappropriate prescribing in older adults during a HMR; and set the groundwork for a larger randomised control study.
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Australian Study for the Prevention through Immunisation of Cardiovascular Events
Expand descriptionThis is a multi-centre trial to investigate the effects of the pneumococcal vaccination in the primary prevention of heart attacks and strokes. People aged 55 to 60 from 6 sites around Australia will be invited to participate in the study. The selected participants will attend a clinic in their area and will be randomly given the pneumococcal vaccine or a placebo vaccine. Outcomes on the expected 6000 participants will be ascertained by health record linkage with government databases after 6 years.
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The effects of prazosin on Rapid Eye Movement (REM) sleep and emotional memory in healthy young adults
Expand descriptionThe purpose of this study is to examine the effects of the medication prazosin on: 1) the quantity and quality of Rapid Eye Movement (REM) sleep; and 2) emotional memory. This is so we can learn more about the basic effects of the medication in healthy adults as a step towards better understanding how the medication might help those with Posttraumatic Stress Disorder. The hypotheses are: 1. Increasing doses of prazosin will lead to greater quantity of REM sleep and fewer disruptions of REM sleep (e.g., fewer awakenings during REM sleep) 2. Increasing quality of REM sleep, resulting from increasing doses of prazosin, will lead to improved overnight memory for emotional pictures.