ANZCTR search results

Wrist fractures in patients are commonly managed using internal fixation. At the Royal Adelaide Hospital last year, 175 distal radius plating procedures were performed. Austofix have designed a new plate, the “VRP 2.0”, with the following proposed advantages over the current commonly available volar radial plate systems : 1. The plate is universal and not “sided” – this has beneficial effects in simplifying implant choice in theatre, as well as minimising hospital stock / inventory 2. The Locking mechanism is unique, and patented 3. The plate is lower profile than many on the market 4. The available angle for the variable angle screws has a range of 40 degrees, compared to 30 degrees for other systems. This may allow more accurate fragment specific fixation, and thus improve maintenance of fracture reduction, and hence eventual functional outcome. 5. The system offers improved instrumentation over currently used systems To confirm the clinical benefits of the Austofix VRP 2.0 plate system a combined prospective randomised controlled trial is proposed. This trial will compare outcomes of patients managed with the Austofix VRP 2.0 vs those managed with a conventional alternative. The VRP 2.0 plate is TGA registered, and on the approved list of implants with SA Health. Study Hypothesis: Adults with closed distal radius fractures who are managed operatively using the VRP 2.0 plate will perform at least 10 points better on the Patient-rated Wrist Evaluation (PRWE) score than those managed operatively using a conventional distal radius locking plate. Null hypothesis: There is no difference in clinical outcome up to one year post injury between patients managed with these 2 different plating systems. Aim: This study aims to provide high quality evidence for the effectiveness of surgical treatment of distal radius fractures using 2 different plating systems. It is proposed that the study will be conducted using a randomised controlled trial. Results will support and influence the future treatment of this common injury for optimal patient outcome.

Total knee arthroplasty (TKA) is a very common procedure. In the USA it is the commonest surgical procedure performed in the private system over the age of 45yrs. One in five Americans over the age of 54 have had a knee replacement. Other countries are also performing increased number of TKAs. In Australia there are approximately 48,000 TKAs performed each year. Studies have shown that up to 20% of patients are unhappy with the outcome after TKA. These patients are characterised by measures of depression and distress. Considering the expense and complication associated with TKA these figures are concerning, especially as they could be avoidable. STUDY HYPOTHESIS; In patients undergoing a TKA, improved outcomes are associated with a combination of pre-surgical preparation (pre-habilitation) and post-operative rehabilitation using treatments that address unhelpful psychosocial factors and provide training in active pain management strategies. The delivery of these treatments can be successful achieved by an internet-based protocol incorporating electronic peripheral functional monitors and provider- and user-interfaces on a hand-held “tablet” device. Success of this pilot study is assessed by a review of patient satisfaction with the protocol, as well the identification of any problems which can be rectified prior to the commencement of the pivotal trial. In addition, a successful study will be shown by an improvement in function and quality of life and reduced analgesic requirements in patients treated with the Personalised Rehabilitation Program.

There is little research regarding the efficacy of CPR in obese patients. The primary aim will be to assess whether hospital staff trained in BLS can deliver effective chest compressions in the setting of a CPR simulation using a dummy which is modified to reflect a patient with morbid obesity. Aim of study: * The aim of this study is to explore whether chest compressions in an obese patient are an effective part of the BLS and ALS algorithm and should continue to be used as part of resuscitative efforts during a cardiac arrest. In addition, this study aims to explore whether providers of CPR fatigue more rapidly when delivering CPR to morbidly obese patients. Primary Outcome: * The primary outcome is to measure the efficacy of chest compressions in a morbidly obese scenario. This will use digital mannequins to record the quality and adequacy of chest compressions over a period of 2 minutes of uninterrupted CPR. Effective CPR will be defined as a composite measure of adequate depth of compression, adequate time for recoil and at an adequate rate for more than 90% of compressions delivered. Secondary outcomes: * Adequacy of each component of CPR (namely depth, adequate recoil and rate). * Time taken for staff to fatigue when performing CPR on a morbidly obese mannequin. It is known that the maximum amount of time a member of staff can perform effective CPR for is 2 minutes in a normal scenario. * Staff discomfort/pain experienced performing CPR. * The association between perceived effectiveness of chest compressions by staff and recorded adequacy.

Pulmonary rehabilitation (PR) guidelines and reviews of current research repeatedly state that PR programs should be between six and 12 weeks, with a recommended duration of eight weeks, but have been unable to draw significant conclusions regarding an optimal duration of PR programs to achieve improvements in exercise capacity and health-related quality of life. Aim : To evaluate the effect of an eight week pulmonary rehabilitation program compared to a 12 week program on exercise capacity and quality of life in people with COPD. Hypothesis: An eight week PR program is equivalent to a 12 week PR program at improving exercise capacity in people with COPD. Design: This is a multi-centre study where 68 participants will be recruited from pulmonary rehabilitation sites across the Sydney Local Health District. A randomised controlled trial design will be used with participants randomally allocated to one of two groups: 1. an eight week PR program or 2. a 12 week PR program. Participants will be asked to complete exercise tests and questionnaires at baseline, four weeks, eight weeks, 12 weeks, six months and 12 months follow-up. Participants will also be asked to wear physical activity monitors at baseline, seven weeks, at completion of their respective exercise programs (eight weeks or 12 weeks), six months and 12 months follow-up. This research will determine if an eight week PR program is equivalent to a 12 week PR program.

Aim: To investigate the effects of a reduced sodium bread on sales and overall sodium intake in remote Indigenous communities. Study design: Communities stores will receive salt-reduced study bread (300mg/100g) (intervention communities) or regular salt study bread (400mg/100g) (control communities) to stock on store shelves for 12 weeks. Population: Remote Indigenous communities serviced by Arnhemland Progress Aboriginal Corporation (ALPA) or Outback Stores (OBS) in Northern Territory, Western Australia or South Australia and where Study bread represents >=45% of the market share for bread sales will be invited to the study (29 communities meet this criteria). Outcomes: - Change in sales (market share and total dollars) - Change in total sodium of all food and drink purchases

Azithromycin and doxycycline are antibiotics that are widely used in the management of sexually transmissible infections (STIs). STI management guidelines in Australia, the UK and US all recommend the use of azithromycin (1g single dose, orally) or doxycycline (100mg, orally, twice daily for 7 days) for uncomplicated urogenital chlamydia with the former preferred for its ease of dose and minimalisation of non-adherence. The most recent meta-analysis shows that the regimens are comparable with only a marginal increase (3%) in efficacy in favour of doxycycline over azithromycin. However, it has been hypothesised that treatment regimen may influence patient’s sexual behavior, placing them at increased risk of early re-infection. Patients on doxycycline – a 7-day daily regimen, may be more mindful of their infection status because they need to take a daily dose and may not re-engage in unprotected sex until dosage is completed. On the other hand, those on single dose regimens may feel more confident that their condition has been treated or may forget about their infection and may re-engage in sexual activity earlier than those taking doxycycline, potentially making them more at risk of re-infection. To our knowledge, this has never been formally studied and represents a knowledge gap in the literature, necessitating this study.

We have designed a home-based, intensive four week speech exercise program designed to improve speech in patients with ARSACS. The treatment protocol is based on principles of motor learning and neuroplasticity with a focus on improving intelligibility and vocal control. Exercises and feedback were created to enhance self-monitoring and include computer based aural, visual and results feedback and self-management.

We have designed a home-based, intensive four week speech exercise program designed to improve speech in patients with spinocerebellar ataxia or Friedreich ataxia. The treatment protocol is based on principles of motor learning and neuroplasticity with a focus on improving intelligibility and vocal control. Exercises and feedback were created to enhance self-monitoring and include computer based aural, visual and results feedback and self-management.

The PISA project seeks to reduce Australia’s future dementia burden by elucidating methods to identify those Australians at the very early stages of dementia. This project aims to achieve this goal by monitoring participants’ physical, cognitive and neurobiological ageing in a cross-sectional, longitudinal design. The tests used in this study include cognitive testing, MRI examinations, PET imaging examinations and blood sample collection. Participants will undergo testing once every two years, over a five year period. Participants will also be given a wearable smart sensing device that will record personalised health data in day to day life, over the course of the study.

This study will test the safety, tolerability and effectiveness of an experimental treatment called “LeY CAR-T cell therapy”in treating solid tumours that carry the Lewis Y marker. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have an advanced solid tumour that is positive for the Lewis Y antigen. Study details The Lewis Y antigen is a molecule that coats the surface of a cancer cell and is not usually detected by T-cells. The “LeY CAR-T cell therapy” may help the T-cells to find and destroy the cancer cells more easily. In this study, the T-cells will first be collected using a procedure called “Apheresis” that takes part before the study treatment. Apheresis collects some of the white blood cells (also called Leukocytes) including T-Cells from the blood. The collected T-cells will then be modified in the laboratory by a viral vector, to specifically target the cancer cells that have the Lewis Y marker on their surface. After T-cells have been modified, the viral vector will be separated from modified T-cells and removed. Modified T-cells can now be called CAR-T cells. The finished LeY CAR-T cells will then be infused back into the body, without the viral vector. As well as the LeY CAR-T cell therapy, patients will receive by lymphodepleting conditioning chemotherapy as intravenous fludarabine and cyclophosphamide for 3 consecutive days prior to cell infusion to increase immunosuppression and improve persistence of engineered T-cells. LeY CAR-T cell therapy is an experimental treatment. This means that it is not an approved treatment for LeY expressing solid tumours in Australia.