ANZCTR search results

Anterior Cruciate Ligament (ACL) reconstruction is an ever evolving subject. Significant improvements have been seen for this procedure over the past few decades, yet we still have high complication rates in the general population. Loss of extension post reconstruction has been reported as having an incidence as high as 59%. A loss of more than five degrees of extension can cause significant gait abnormalities, patellofemoral pain (pain behind the knee-cap) and quadriceps weakness. This in turn can affect the patient's confidence in returning to full activities. There are several causes of loss of extension post ACL reconstruction. The factor that will be assessed in this project will be the angle of the knee during graft fixation intra-operatively. Traditional orthopaedic teaching dictates tensioning the graft with the knee positioned between 20-30 degrees. There has been increasing evidence (mainly in biomechanical studies conducted in cadavers) that demonstrates over-constrained knees when the graft is tensioned in a flexed knee instead of a fully extended knee. This study aims to quantify the loss of extension associated with tensioning the ACL graft in a flexed knee. Patients that are undergoing ACL reconstructions will be included. In these patients we will assess their range of motion in both knees before the operation. During the operation the range of motion of the operative knee will be re-assessed using Computer Navigation for accuracy and reproducibility, The graft will be fixed on the femoral side and temporarily locked on the tibial side whilst the knee is in flexion. Then the knee will go through a full range of motion arc and measurements will be recorded. The graft will then be permanently fixed whilst the knee is in extension and the same motions and measurements will be undertaken. The anterior-posterior and rotational laxity of the knee will also be measured at the end of the operation.

Obstructive sleep apnoea (OSA) is a sleep and breathing disorder characterised by repetitive closure or narrowing of the airway during sleep. The upper airway muscles play an important role in keeping the upper airway open. In addition to the non-respiratory functional tasks of speech and swallowing, they serve an important role in tongue protrusion, airway stiffening/support and dilation during breathing. Conversely, poor upper airway muscle function plays a key role in the pathophysiology of OSA. Indeed, more than 30% of patients with OSA have minimal activation of the upper airway muscles during airway narrowing and closure during sleep. Although recent studies highlight the potential of oropharyngeal muscle training as a non-invasive approach to therapy a major unresolved question is: how does oropharyngeal exercise training improve upper airway muscle function to reduce OSA severity? To answer this question, the current study will evaluate changes in OSA severity and upper airway physiology following an upper airway muscle training protocol.

The receptor-binding domain (RBD) in SARS-CoV-2 S protein has been identified as the component required for coronaviruses to enter the human cells using the human receptor angiotensin converting enzyme 2 (ACE2). The investigational vaccine, RBD SARS-CoV-2 HBsAg VLP vaccine, is a subunit vaccine where the RBD antigen is conjugated to the hepatitis B surface antigen to allow the stimulation of the immune system to produce anti-RBD (CoV2 Receptor binding domain) antibodies. The study will be conducted in two stages: phase I and phase II. Phase I will include healthy adults aged 18 - 45 years and evaluate the safety and immunogenicity reported after two-doses of vaccine when compared with placebo. Phase II will include a separate group of healthy adults participants aged 18 - 79 years and evaluate the safety and immunogenicity reported after receiving a single dose or two-doses of vaccine 28 days apart when compared with placebo.

This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part 1) followed by a multiple ascending dose (MAD) part (Part 2). Part 1 consists of two single-dose cohorts receiving either active therapy, AT-301B, or the placebo comparator AT-301A. Part 2 is a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days. The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers

This study is a three-arm randomised control trial of an online intervention to reduce alcohol consumption in middle-aged women. The underlying theory for the intervention is based on the assumptions of the Integrated Behavioural Model (Fishbein, 2000) and the Transtheoretical Model of Change (Prochaska, 1979). Participants in the intervention will have access to core features that include goal setting, tracking of alcohol consumption, four modules of content, and associated challenges to operationalise their learnings. Participants will also complete Ecological Momentary Assessments (EMA) to record their alcohol consumption twice weekly over a 6-week period. We hypothesise that by the end of the intervention, participants in the online intervention group will report a significantly lower alcohol consumption than participants of the control group without weekly assessment (H1a). We also hypothesise that by the of the intervention period, participants in the online intervention group will display significant increases in; their awareness of harms associated with alcohol consumption (H2a), their motivation to reduce their alcohol consumption (H2b), social support (H2c),and current health status (H2d); and significant decreases in alcohol-related harm (H2e) and current level of stress (H2f), when compared to the control group without weekly assessment.

This trial evaluates a transsdiagnostic program that helps people to cope with stress in times of crisis. The program, titled Positive Mood Program (PMP), trains people to engage in positive activities, mood enhancement, social connections, and stress management. This program has been shown to reduce stress and depression, particularly at times of stress. This project aims to conduct a rapid trial of a brief psychological intervention, the Positive Mood Program (PMP), to reduce distress and improved mood associated with concerns about COVID-19. There is an urgent need for publicly available strategies to reduce COVID-19 related distress. This brief program will be offered via videoconferencing in to allow for social distancing on a group basis. We hypothesise that PMP will result in greater reductions in distress and worry relative to provision of the same strategies provided to participants who can work on them in a self-guided manner. Adults who screen positive for psychological distress will be randomized to PMP or a control condition. PMP will comprise 7 x 60-minute sessions delivered by a clinical psychologist via videoconferencing to groups of 4 people at a time. The control arm will provide people with handouts to work through the strategies in a self-guided manner. All participants will be assessed at baseline, post-intervention, and 3 months follow-up. Participants will be reimbursed $50 for completing all assessments.

Pain during outpatient intrauterine device (IUD) insertion and fear of that pain are barriers to people selecting them as long term reversible contraceptives. Methoxyflurane is an inhaled pain relief medication which has widespread application in conscious surgical procedures. This is the first study to assess the acceptability of methoxyflurane for patients having outpatient IUD insertions. Aims: Our hypothesis is that patients using methoxyflurane during their outpatient (awake) intrauterine device insertion would find the medication acceptable and would want to have it in the same situation again. Materials and Methods: Open, single-centre, single arm pilot study. 30 participants and their clinicians completed questionnaires at the time of their IUD insertion.

The aim of this project is to investigate the influence of white noise on auditory and language processing and examine how this influence is modulated by changes in dopamine. More specifically, we will combine the behavioural manipulations of auditory white noise and word learning with the pharmacological manipulation of dopamine, which is the neurotransmitter implicated in learning and attentional processes. Our objective is to quantify the influence of white noise and dopamine by measuring the accuracy of people’s responses for the word-learning tasks as well as using fMRI to measure changes in brain activity while people perform the tasks.

With the emergence of the novel COVID-19 virus, medical staff are continuing to expose and put themselves at risk in their day to day work. This virus is known to spread through primarily droplet exposure. Frontline medical staff are at highest risk in being exposed to droplets from the potential asymptomatic or mild COVID-19 individuals. A simple, but effective, means to reduce droplet spread is the use of face masks. However, wearing face masks outside operating theatres is not routine practice in Australian Hospitals, as such, there is concern that it could cause fear and anxiety in already stressed patients. Such concern has caused a dilemma among some medical staff with regards to masking or de-masking while at work. In order to find out whether this concern is real, i.e., how patients feel about the change in practice by medical staff wearing face masks, we designed this written questionnaire survey to examine patients’ attitudes towards masking the medical staff at work during COVID-19 pandemic.

Heart attack is the leading cause of morbidity and mortality globally, claiming 8,623 Australian lives in 2014 (i.e. 24 deaths/day). The heart attack is caused by the blockage of the blood flow in the heart, requiring emergent life-saving treatment to restore the blood flow using a balloon or a stent. For the last 30 years, however, death rates for the heart attack have not improved. One of the key reasons for this is the blockage of smaller micro-vessels of the heart. This micro-vessel abnormality occurs in up to 60% of patients with heart attacks and is independently associated with worse outcomes. Nevertheless, currently no established therapeutic options exist. Therefore, we will perform a prospective randomised controlled trial (RCT) to treat the micro-vessel blockages with a novel method using ultrasound with contrast agent (i.e. sonothrombolysis). Many animal studies have demonstrated that sonothrombolysis can break up blood clots of both large and small vessels, and improve the blood flow. A recent, single-centre human RCT led by Prof Porter in USA confirmed that sonothrombolysis opens the micro-vessel blockages after heart attack and improves the heart function. Next logical step is to evaluate this method in multicentre setting with a larger scale. After close communications with Prof Porter, we established our protocol for a prospective multicentre RCT with sham procedure to test our hypothesis that additional sonothrombolysis to standard treatment for heart attack would reduce heart muscle damage and improve heart function in short term and improve patient survival long term. We will run this trial across three Australian hospitals. We will be studying their outcomes during their hospital stay and following their progress with cardiac imaging over 6 months. The findings from this trial have the potential to significantly improve the overall prognosis for patients having a life-threatening heart attack and to change our standard of care and clinical guidelines.