ANZCTR search results

There is currently no literature on the use of far cortical locking screws when compared to standard locking screw constructs in human patients, we know of one RCT currently in progress with Canadian Orthopaedic Trauma Society (COTS). The COTS study will look at the treatment of distal femoral fractures using Zimmer MotionLoc screws versus standard locking screws in all age groups and include high impact trauma cases. This study proposes to look more specifically at callus formation and fracture healing in older patients treated with FCL versus standard locking plate fixation, with the inclusion of peri-prosthetic distal femoral fractures. Fixation in these fractures is generally more challenging and therefore it is of interest to establish whether FCL is a valuable option also for these cases. Fracture healing by secondary healing with bridging callus formation will be the principal measurable outcome to demonstrate the potential differences in fixation between FCL and standard locking screws.

Up to 50% of OSA patients are unable to tolerate CPAP therapy leaving many OSA patients without treatment. Mandibular Advancement Devices are a suitable alternative for many patients however, as individual responses to MAD vary, combination therapies including CPAP-MAD are increasingly considered as an alternative therapeutic option and may result in lower pressure requirement and improve tolerance. The present study aims to: 1. evaluate MAD response as a function of nasal resistance and 2. evaluate the impact of combination therapy on pressures required to stabilise the upper airway, in participants who are non-responders to MAD treatment alone.

This study will investigate the effectiveness of Quittr, a smoking cessation app. Who is it for? You may be eligible to join this study if you are a current smoker interested in starting a quit attempt. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have access to full features Quittr, which include health and financial statistics, educational/behavioural support content, an achievement system, and novel game features. Participants in the other group will have access to the same features except the game. After 28-days the study will end, but participants will continue to have access to the full featured version of the app indefinitely. Participants will be prompted to indicate how many cigarettes they smoke each day, and usage data will be automatically recorded to a web service. Smoking activity, engagement and retention of users will be determined after the 28 day trial window closes. Participants who indicate they have successfully quit smoking at the end of the trial will optionally be able to demonstrate this using a self-administered cotinine urine analysis test strip. Volunteers will be posted an simple test kit, asked to photograph the result strip, and return the photograph by email. In return, the volunteer will be granted a $40 gift card as remuneration.

This study will help to better understand the effect of empagliflozin on the sympathetic nervous system in people who have pre­existing cardiovascular disease. The sympathetic nervous system regulates heart rate, controls blood pressure, regulates sweating and release of glucose from the liver. The primary aim is to answer this question: *What effect does empagliflozin have overall on the sympathetic nervous system? The secondary aims are to answer these questions: *What effects does empagliflozin have on the sympathetic nervous system activity in the heart, kidney, muscle and sweat gland? *What effects does empagliflozin have on pressure in the heart and on heart muscle contraction and relaxation? *What effects does empagliflozin have on glucose and metabolite levels? The study is a randomised trial with 18 people per arm: *Group 1 ­ empagliflozin *Group 2 ­ placebo Total length of study participation will be approximately 19 weeks, i.e. a screening period and baseline assessment period that will last up to 3 weeks, a treatment period lasting 12 weeks, and a safety follow­up period lasting 4 weeks. There will be up to 9 study visits. During this study, there will be medical history and medication reviews, physical examination, assessment of blood pressure, heart rate and weight, collection of blood and urine. To answer the primary aim, there will be baseline and end of treatment kidney and heart noradrenaline spillover studies and arteriovenous metabolite gradient sampling. This involves sampling from a vein in the back of the hand or arm, from a small tube in the artery in the arm, and from a catheter placed via a vein in the arm, to sample the blood in the heart vein, kidney vein and liver vein. To assess accurately the rate of noradrenaline release from the heart and the kidneys into the bloodstream, a small amount of a radioactive substance will be infused continuously at a low rate through the tube in the arm vein. In the same tube, there will be infused a chemical called para aminohippuric acid (PAH) to measure the kidney blood flow. To answer the secondary aims, there will be baseline and end of treatment tests of electrocardiogram, echocardiogram (heart ultrasound), questionnaires on general health, anxiety and depression, Sudoscan (nerve activity related to sweating), ankle brachial index (which assesses the blood pressure in all 4 limbs), nerve activity testing in the calf muscle, and a maximum exercise capacity test on a stationary bicycle.

Endometriosis is the leading cause for pelvic pain in women and is also associated with infertility. Twenty percent of patients with endometriosis suffer from Deep Infiltrating Endometriosis (DIE), defined as solid endometriotic masses situated deep in the peritoneum. Laparoscopic surgery is a very common treatment for DIE, however, its implications on future pelvic organ function are not yet clear. The overall aim of our research is to investigate the influence of laparoscopic surgery for DIE on bowel, bladder and sexual function. We further aim to compare the effect of different surgical approaches on bowel and bladder function after bowel surgery for DIE. Our hypothesis is that extensive and radical surgery for DIE (such as bowel resection) will be found to be associated with long-term adverse bladder and bowel function and that less radical surgical approaches (such as bowel shaving) would be associated with lower rates of bladder and bowel dysfunction. The Royal Women’s Hospital is one of the largest women’s health institutes in Australia and is a major referral center for patients with pelvic pain and endometriosis. Patients will be recruited in the outpatients clinic and through the private rooms of the investigators in Frances Perry House and Epworth Richmond. Questionnaires will be filled before and at three points of time after surgery (6 weeks, 6 months, 1 year). Up to date, there is very scarce data regarding long term function after laparoscopic surgery for DIE and some of it is contradicting. This study intends to recruit a significant amount of patients in order to shed light on this question. The data collected in this study will allow us to better council patients before undergoing major surgery for DIE.

This pilot study aims to investigate the effect of a novel mobile phone based music-motor therapy software application (app) on human motor control. There is considerable interest in using music therapy combined with movement as a way to change the brain and improve functional recovery following injury to the central nervous system. To date, current therapies incorporating movement and rhythmic cues (metronome or music) are effective at improving upper extremity motor control and gait in neurological disorders, including Parkinson’s Disease, Stroke, and Traumatic Brain Injury (TBI). However, these therapies have a number of limitations, including lack of feedback about motor responses in relation to the music, and lack of portability. We have developed a novel mobile software application – GotRhythm – that uses mobiles and wireless wearable sensors to deliver music-motor therapy to patients with real time biofeedback. The proposed study will investigate the effectiveness of this new music-motor therapy app at improving motor control in patients following neurotrauma and and allow us to optimise future treatments for neurotrauma patients.

The proposed study aims to conduct a double-blind, randomized, sham-controlled proof of principle trial to establish the efficacy of Theta Burst Stimulation (TBS) treatment in fibromyalgia. Fibromyalgia and related disorders present a substantial health problem, with current treatments limited in their efficacy and associated with a number of side effects. This study will explore for the first time in fibromyalgia a novel non-pharmaceutical intervention, TBS; a non-invasive brain stimulation method. TBS is a powerful new alternative to standard non-invasive brain stimulation methods as it can be applied in a much more time efficient manner and may result in greater clinical benefit. If successful, the application of this method for fibromyalgia may be applicable to related disorders such as Chronic Fatigue Syndrome. This is a randomised sham-controlled trial study, in which 52 participants with a diagnosis of fibromyalgia will be recruited. Participants will be randomised into one of two conditions- (1) Active TBS condition and (2) Sham (or ‘placebo’) TBS condition. Participants will have two weeks of twice daily stimulation followed by a tapered two week dose of twice daily treatments on Monday, Wednesday and Friday only. Participants will be asked to a number of self-report questionnaires at baseline, at the end of each treatment week (weeks 1-4) and at the 1 month follow up appointment, as well as will undergo the collection of neurobiological data (TMS-EEG) at baseline, end of week 4 and follow-up.

A common complication in whole blood donation is a vasovagal reaction (VVR), being 90% of all incidence reports. A VVR causes a donor to feel light-headed, dizzy or faint during or after their donation. These reactions can be triggered by pain or emotions (e.g., fear of needles), or when standing up too quickly after donation. These reactions have a negative impact on donation satisfaction, donor safety and wellbeing, and donor return rates. VVRs pose a particularly high risk to first-time donors, those aged less than 30 years, females, individuals with a low body weight, and donors who report high pre-donation anxiety. In 2016 in Australia, 58% of whole blood donors did not return to donate within six months following a phlebotomist-registered reaction compared to 35% who had an uncomplicated first donation. Therefore, reducing risks to donors is inherently important. A technique which has received increasing support in reducing the rate of VVRs is applied muscle tension (AMT). AMT has been indicated to benefit the donor both physiologically, through an immediate increase in blood pressure, and psychologically, through distraction and anxiety reduction. At the Australian Red Cross Blood Service, AMT is currently included in the standard operating procedures to treat VVR but international studies have demonstrated the potential of utilising the technique as a prevention method. Practicing AMT during the entire donation procedure results in significantly fewer self-reported VVRs, increased completed donations, less chair reclining, reduced feelings of anxiety and greater intentions to return. However, these studies have reported low adherence to the technique among donors: only 22% of study participants reported using AMT throughout their donation. Despite growing evidence of the efficacy of AMT in reducing VVR, no research has examined how AMT can be successfully implemented into the routine blood donation procedure and maximise donor adherence. Consequently, the impact of AMT in day to day practice has not been examined and its potential to increase donor retention and contribute to the maintenance of a stable blood supply has yet to be fully realised. The overall aim of this project is to examine the effectiveness of AMT within Australian donor centres in a randomised controlled trial.

This randomised waiting list controlled trial aims to test the impact of an intervention designed to enhance ongoing physical activity participation in women aged over 50. 100 female University staff aged 50 years and older will be recruited via University newsletters and websites. Exclusion criteria are limited English skills, a medical condition precluding participation in regular exercise, or currently meeting physical activity guidelines. Upon giving informed consent participants will complete a baseline survey on physical activity knowledge, attitudes and behaviour, physical functioning and mood. Current physical activity level will be measured with an accelerometer, worn on the hip for 7 consecutive days to determine the average daily step count. Participants will then be randomised to attend a workshop immediately, or after 3 months. At 3 months post randomisation, similar surveys and wearing the accelerometer will be repeated. The intervention will be a one-hour workshop to give information about the importance of physical activity for maximising physical and mental health and preventing disability in women, and to provide information about existing opportunities to participate in and enhance physical activity. An email list and on-line discussion group will be set up for those wishing to remain in contact. Workshop materials will be made freely available at the completion of the project, and participants will also be offered the use of a pedometer or internet-connected activity tracker (Fitbit) for the duration of the study, to provide motivation and feedback to increase activity levels. Participants randomised to the control group will be allocated to a waiting list and receive access to the intervention after the 3-month follow-up period. The primary outcome will be the proportion of people achieving an average of at least 10,000 daily steps, measured with an accelerometer. The secondary outcomes will be the proportion of people achieving adequate physical activity levels as recommended by national physical activity guidelines, average total number of hours of physical activity per week, change in perceived benefits of and barriers to exercise participation, physical functioning, mood. Analyses will be pre-planned, conducted while masked to group allocation and will use an intention-to-treat approach. 50 participants per group (i.e. 100 participants) will provide 80% power to detect 30% more people in the intervention group reaching the recommended 10,000 steps/day than the control group. This calculation assumed a proportion of 27% compliance with the 10,000 steps/day activity level in the control group, 15% dropout rate and 5% alpha. This sample size is also expected to be sufficient to detect between-group differences in the order of 10-15% for the secondary outcome measures. If shown to be effective, this study is an approach that could be implemented more broadly to increase the population health impact.

This research project will investigate the feasibility and acceptability of combined Errorless Learning (EL) and Spaced Retrieval (SR) techniques in a safe transfer program to improve gait and prevent falls in adults aged 65 and over with mild to moderate cognitive impairment and higher level gait disorders. The assessments and intervention will be conducted at participants' home by a senior occupational therapist who is a co-investigator of the study. The 3 week intervention program starts with more intensive therapy in week 1 (4 sessions, 30min each session) and gradually decreases the intensity in week 2 (2 sessions, 30min each session) and week 3 (1 session, 30min each session). Following demonstration of the transferring task by the therapist, participants are provided with verbal cues prior to each step when performing the task (EL) and the time intervals between each session gradually increase (SR). The transfer training practice will be generalised into real life activities in week 2 and week 3 of the program. Follow up assessments at 3 months post intervention will also be conducted at the participants home. This project will form the pilot study for a larger multi-centre clinical trial, which will assess the long-term effect of this novel falls prevention program targeting older adults with cognitive impairment and higher level gait disorders.