ANZCTR search results

This is a prospective, single-site, randomised controlled trial on patients undergoing THA. The study will enrol a minimum of 150 patients over a two (2) year period from two orthopaedic surgeons at one (1) site. All cases must satisfy the inclusion/exclusion criteria. Study participants will be recruited from a cohort of THA patients who will receive a femoral stem (MetaFix or TriFit) and Trinity acetabular cup and followed up by Dr Matthew Wilkinson (Mater Health Services North Queensland) and Dr Kaushik Hazratwala (Mater Health Services North Queensland). Preoperative planning using the Corin OPS™ 3D planning component will be used for all study participants to determine the optimal acetabular and femoral component models, type and size for each patient. The preoperative templates will also be used to determine the optimal position and orientation (abduction and anteversion angles) of the implant, relative to the patients’ pelvic parameters, bone geometry and bone landmarks. Whilst the same method will be used for preoperative templating for all study participants, the surgical technique used for executing acetabular and femoral implants intraoperatively will differ. In this study, patients will be randomised to one of three surgical groups: Group 1: Conventional, unassisted (freehand) methods Group 2: Corin Optimised Positioning System (OPS)™ using patient-specific, image-derived instrumentation and laser-assisted positioning technology (IDI+LAT) Group 3: Intellijoint Hip® infrared navigation system only

Chronic Obstructive Pulmonary Disease and Severe Asthma are chronic obstructive airway diseases associated with a high disease burden. They are complex diseases that can be complicated by significant comorbidity. A new and emerging approach to these conditions is to focus on the identification and treatment of the processes that underlie individual disease. These components are termed ‘treatable traits’. An important aspect of the treatable traits approach is objective monitoring to select and continue therapy. Most current monitoring approaches are assessed using nonobjective measures, that do not capture improvements after treatment. Functional lung ventilation imaging with quantification using Technegas may address this clinical need. Tomographic pulmonary scintigraphy (ventilation/perfusion single photon emission computed tomography: V/P SPECT) is a nuclear medicine investigation that gives a 3dimensional functional map of the ventilation and perfusion of the lungs and shows how these are affected by disease. We believe that this new imaging approach may be a useful objective measure of disease and treatment response in severe asthma and COPD. In the current study, we aim to quantify: 1. Whether functional lung ventilation technology can objectively quantify ventilation heterogeneity in patients with severe obstructive airway disease (asthma or COPD). 2. Determine whether functional lung ventilation imaging can be used to quantify response to therapies.

1. Background Burns are a painful and traumatic experience. Literature has found that using pharmacological and non-pharmacological interventions aid in providing appropriate pain management and significantly improve paediatric burn outcomes. Overall, there seems to be some evidence that reduced pain and anxiety positively influences re-epithelialisation rates however current literature fails to fully explain the effects of pain and anxiety and their links with wound healing. This study will determine if Burnaid® is an effective treatment for reducing pain in the acute period of a burn injury. It is hypothesised that a reduction in pain, as well as stress/anxiety, will then improve re-epithelialisation time in comparison to plastic wrap which is standard practice at our institute, a large metropolitan paediatric hospital located in Brisbane, Australia. 1.2 Methods/Design A randomised controlled trial will be conducted assessing the effectiveness of Burnaid® hydrogel dressings as an analgesic adjunct to cold running water (CRW) first aid for the treatment of paediatric burns. Participants will include children aged between 0 – 16 years with an acute thermal burn injury with a total burn surface area (TBSA) of < 20% admitted to our emergency within 24hours of the burn occurring. Participants will be stratified into one of two groups based on factors which increase pain intensity. The trial will then randomise patients into one of two groups: 1) Plastic wrap which will serve as the control arm or 2) Burnaid® which is the intervention arm. The trial requires a minimum of 29 participants per group, which will be assessed from day of injury to re-epithelialisation. The primary outcome of the trial is the effect of the intervention on reducing acute pain. Secondary outcomes include: days to re-epithelialisation, Physiological changes that indicate pain intensity (pulse rate, temperature and respiratory rate), analgesia and distraction techniques required, , cost effectiveness, staff perspectives on the treatmen, Health related Quality of Life (Child Health Utility 9D - CHU9D) and salivary cortisol and a-amylase ratio (informing influences of stress and anxiety) 1.3 Discussion This study will provide comprehensive data on the analgesic properties of Burnaid® hydrogel dressings as an adjunct to CRW first aid for the treatment of acute paediatric thermal burns. If the intervention shows to be effective in reducing acute pain, Burnaid® dressings will be integrated as standard care practices at our institute. This study replicates a real-world scenario in order to identify clinically significant analgesic and would healing effects.

The Rapid Iron Infusion Study (RIIS) is a randomised controlled trial for Aboriginal children with severe iron deficiency anaemia, The aim is to assess whether a single intravenous infusion of ferric carboxymaltose (Ferinject) given over 15 minutes in children prior to their discharge from hospital compared to the standard treatment with intramuscular iron injections as per CARPA Manual, will improve haemoglobin levels and reduce the risk of further anaemia. The potential benefits of rapid iron infusions include higher haemoglobin levels, fewer painful intramuscular injections, better adherence to recommended treatment, and less use of primary health care resources.

The aim of this study is to evaluate the incidence and type of psychosocial needs in 14-24 year old offspring of women with early or metastatic breast cancer. Who is it for? You may be eligible to join this study if you are aged 14-24 years and have a mother diagnosed with stage I to IV breast cancer. Study details Study staff will phone participants to obtain demographic information about gender, age, schooling, place of birth, family situation (who they live with), whether they have any important medical conditions and any cancer history of their immediate family. Participants will be emailed a link to an online survey comprised of 2 questionnaires online which they are required to complete within 28 days. We anticipate time to participate and complete all aspects of the trial will take individuals a total of 30-40 minutes. Information collected will be analysed with the aim of identifying what the needs and the best types of support that can be provided to help other young people who also have mothers with cancer.

Currently, exercise guidelines for people with cystic fibrosis (CF) recommend 30 to 60 minutes of aerobic exercise on most days; a recommendation that is consistent with that provided for the general population. In addition to the usual demands on a person’s time such as work, study and family, people with CF have a high daily treatment burden involving airway clearance, medical and nutritional treatment, which are can take up to 4 hours per day to be completed. Therefore, completing 30 to 60 minutes of exercise per day can be difficult to achieve. A novel training approach, such as high intensity interval training (HIIT) may represent a more efficient option to increase exercise capacity. High intensity interval training has been demonstrated to improve exercise capacity in healthy individuals, as well as people with chronic respiratory disease. The main benefit of HIIT is the reduced time commitment, compared to other forms of exercise training. Currently, there are no guidelines for the use of HIIT in people with CF. The proposed PhD will, in people with CF, implement a HIIT program in a supervised setting over an 8 week period to investigate the effects of the program on exercise capacity, health-related quality of life (HRQoL), exercise self-efficacy, feelings of anxiety, depression, enjoyment and muscle oxidative capacity. It will also report on: (i) the proportion of participants who develop post-exercise muscle soreness and the severity of these symptoms; (ii) the tolerance of the HIIT program; (iii) the cardiorespiratory and symptom responses to HIIT over the 8 week program and; (iv) the behaviour change techniques. We hypothesize that in people with CF, 8 weeks of supervised HIIT will change exercise capacity, HRQoL, exercise self-efficacy, enjoyment and muscle oxidative capacity over and above any change seen with usual care.

The aim of this study is to assess the efficacy of delivering chemotherapy treatment through the arteries directly to the liver, bypassing the main blood supply throughout the body. Who is it for? You may be eligible for this study if you are aged over 18 years, have hepatic metastases from histologically proven adenocarcinoma of the colon/rectum, and have had some systemic chemotherapy. Study details Once enrolled, patients will have baseline scans and will have the AVAS device implanted. The patient will be admitted to hospital up to twice a week to be treated with the liver directed therapy until they have received 5-7 treatments of oxaliplatin, after which the device will be explanted. Oxaliplatin is approved in Australia as chemotherapy treatment for liver metastases from colorectal cancer (via IV infusion), but has not previously been approved when delivered to through the arteries to the liver using the AVAS study device. All patients will also receive Capecitabine from enrolment to 4 weeks after the AVAS explantation as a form of systemic disease management. The patient’s tumour will be scanned 4 weeks after explant of the device, and the patient will be followed up for two years. An additional CT scan will take place 8 weeks after the AVAS explantation which will be used to determine progression free survival for each patient cohort. The treatment proposed in this study is based on the hypothesis that direct arterial infusion of chemotherapy to metastatic tumours of the liver whilst the blood flow to the organ is isolated could potentially yield benefits that cannot be achieved with existing treatment regimens.

The aim of this study will be to examine the efficacy of a targeted pre- and post-operative exercise program on treatment related side effects after radical prostatectomy. Who is it for? You may be eligible to join this study if you are a male aged 18 years or above and are scheduled for radical prostatectomy by one of the four selected surgeons. Study details Participants in this study will be randomly allocated (by chance) to one of two groups: 1) Exercise; or 2) Usual Care. The exercise group will participate in a structured exercise program 1-2 months before surgery and for 3 months after their surgery. The intervention involves individualized exercise prescription supervised by exercise physiologists during 3 group-based sessions weekly in an exercise clinic. The usual care group will receive standard medical care. Both the Exercise and Usual care will receive best-practice pelvic floor physiotherapy treatment before and after surgery. Assessments will be conducted at the following time points: baseline (-1-2 months), pre-operation (0 months), post-operation (1 month), post-intervention (4 months), and follow-up (12 months). We hypothesize that a structured exercise intervention tailored to men with prostate cancer delivered prior to and continuing after surgery will improve patient's rehabilitation outcomes after surgery, in particular attenuate the severity of sexual dysfunction and urinary incontinence.

The aim of this randomised control trial is to evaluate whether students, in particular girls, are more active during the school day if they are wearing their sports uniform as opposed to their normal formal uniform. Sixty primary schools in the Hunter Region and Mid North Coast will be randomly allocated to an intervention or control group.

The aim of this randomised control trial is to assist teachers to increase the amount of scheduled physical activity time they provide across a school week. Schools will be provided professional development, resources, time and access to a support officer to make these changes. Sixty primary schools in HNE and Mid north coast LHD’s will be randomly allocated to either an intervention group or a control group. The final trial endpoint is 18 months.