ANZCTR search results

External fixation is commonly used as a means of definitive fixation of pelvic fractures. Pin site infection is common, with some cases of osteomyelitis and inpatient nursing can be challenging. The aim of this study is to report the outcomes and complications of an alternative minimally invasive technique, known as INFIX, utilising spinal pedicle screws inserted into the supra-acetabular bone and connected by a subcutaneous rod. A single centre prospective case series was performed. The primary outcome measures were fracture stability and displacement at time of implant removal and intra and post-operative complications.

Early mobilisation of intensive care patients has been shown to improve functional outcomes, attenuate-ICU acquired weakness, reduced ICU and hospital length of stay and reduce mortality rates at 12 months discharge (Morris et al., 2008, Schweickert et al., 2009). Despite these benefits, there are many barriers (femoral vascular lines, staffing logistics and sedation management), which still prevent adequate mobilisation of ICU patients (Leditschke et al., 2012). An ICU mobility scale has been generated to qualitatively describe on a continuum the level of mobilisation from nil to independent locomotion of ICU patients. (Hodgson et al., 2014a). A second strongly correlated measure of physical function, the Acute Care Index of Function (ACIF) has also been used to measure ICU patient function, and is advantageous in that it incorporates a neurological assessment and has been shown to predict patient physical function post-ICU discharge (Bissett et al., 2016). In addition, a multinational consensus statement was also published in 2014 (Hodgson et al., 2014b) outlining the safety criteria for the mobilisation of critically ill patients. The statement described which intensive care patient could be safely mobilised and how they could be mobilised. However, it is still possible that these criteria are somewhat conservative compared to existing practices at Canberra Hospital. This study will determine the current barriers to mobilisation at Canberra Hospital ICU and ascertain whether these have changed compared to data collected in 2008 (Leditschke et al 2012). This study will also describe the safety of patient mobilisation at Canberra Hospital in the context of the consensus statement (Hodgson et al 2014b) and describe the IMS and ACIF scores of patients mobilised in Canberra Hospital ICU as part of routine practice.

The primary purpose of this study is to develop and validate a brief questionnaire (up to 5 questions) to identify those children and young people with cerebral palsy who may have feeding difficulties are may be undernourished. The primary hypothesis is that "risk" of feeding difficulties and undernutrition for children and young people with cerebral palsy can be determined using a brief, parent completed questionnaire.

Impairments in memory, attention, and social/psychosocial functioning are common consequences of acquired brain injury (ABI) sustained in childhood and adolescence. However, there exists a dearth of evidence-based interventions that target these difficulties, while only a few studies have evaluated the feasibility of these interventions in an ABI population. This study aims to pilot the feasibility and efficacy of the English version of the Amsterdam Memory and Attention Test for Children (Amat-c), with an online clinician support component, in children and adolescents presenting with difficulties in these functional domains post-ABI. The Amat-c is to enhance children’s attention, memory and executive functioning (EF) skills. The child is trained using specific exercises focusing on deficient cognitive abilities, in an attempt to improve these skills, as well as to impact more generally on cognitive functions. Parents of participating children will have to engage their children in a daily 30 minutes session for 18 weeks. During these sessions families in the treatment group will complete the Amat-c activities. Those in the control group will complete some psycho-education models, and will be invited to receive the Amat-c intervention after it is found to be efficacious. Feasibility of this intervention will be assessed immediately and at 6 months post-intervention using neuropsychological and ecologically sensitive measures. Relative to baseline scores, we expect significant improvements in attention, memory, and functional everyday outcomes both immediately and at 6 months post-intervention. We anticipate that preliminary support for the feasibility and efficacy of this online clinician-supported program will inform current evidence-based practices and optimize childhood/adolescent outcomes post-ABI. Potentially, this will inspire larger future studies and provide an evidence base for the incorporation of the Amat-c into standard clinical care for children and adolescents with ABI.

Symptoms of low mood and depression are common in later life and can include; feeling sad, empty or down, loss of interest or pleasure, feelings of guilt or low self-worth, disturbed sleep or appetite, low energy, poor concentration and thoughts about death. There is now evidence that depression is 23% more frequent among people living in regional Australia than in the city, possibly because of difficulty accessing relevant health services. When feeling low, a person’s motivation to do things can decrease. Some may find that they give up hobbies or activities previously enjoyed, and over time might end up doing very little. This can lead to a further decline in mood and start a vicious cycle that can be difficult to break. One of the ways of overcoming depression and low mood is by changing behaviour, such as gradually increasing activity levels. The results of several studies show that the more activities people engage in the better they feel. Behavioural Activation (BA) interventions encourage participants to meaningfully increase their engagement in activities with the aim of improving mood and sense of achievement. The current pilot study is seeking to test out (pilot) whether a supported self-help behavioural activation intervention designed for older Western Australians living in regional and remote areas is effective at decreasing the severity of depression amongst those who are depressed. The results will be used to improve the program and make it ready for a full clinical trial so that definitive evidence of the effectiveness of the intervention can be obtained. Specific aim of definitive trial: To determine if a greater proportion of older adults with Major Depression living in regional Western Australia randomly assigned to the BA intervention, compared to Standard Care, experience remission of symptoms after 12 weeks.

One of the most common reasons for presentation to a gynaecologist is for abnormal uterine bleeding (AUB). Women suspected for leiomyomas clinically or on ultrasound evidence are likely to be recommended to have surgical treatment for their condition, since medical treatment is ineffective for this presentation. Monopolar electrosurgical resection is frequently used in hysteroscopic removal of fibroids. Main complications include electrolyte disturbances and potential fatal outcomes due to use of hypotonic, non-conductive media (glycine) for uterine distension; and need for removal of the hysteroscope mid-procedure in order to clear the intrauterine cavity of debris, increasing operating time and potentiates cervical trauma. The hysteroscopic morcellator (Myosure (registered trademark)) has become an increasingly used tool to remove submucosal leiomyomas, as well as other intra-uterine pathology such as retained placental remnants. This instrument operates in a normal saline medium, removing the risk of hyponatraemia second to excessive absorption, during mechanical resection and concurrent removal of the fibroid from the intra-uterine cavity. Risk to the patient of fluid overload due to intra-vascular or intra-peritoneal absorption of large quantities of saline may occur. This study will compare the use of a mechanical hysteroscopic morcellator to monopolar electrosurgical hysteroscopic resection to remove submucosal leiomyomas in symptomatic women with AUB-L. We hypothesise that the hysteroscopic morcellator will allow for significantly faster resection of fibroids independent of surgical skill. The primary outcome of the study will investigate cost minimisation of the two different devices in an operating room setting, and determine opportunities for direct and indirect savings in a public health setting. Secondary outcomes will include determining: (1) ease of use of device; (2) completeness of resection, in terms of cessation of operation due to fluid deficit point being reached; and (3) the number of adverse events. This study is a prospective, randomised, single-blinded multi-centre clinical study. Women will be randomised to one of two study groups: 1. Intervention group: Resection of the leiomyoma with the hysteroscopic morcellator (Myosure (registered trademark)) and a normal saline distension medium. 2. Control group: Resection of the leiomyoma with a monopolar electrosurgical hysteroscopic resector with a glycine distension medium. Randomisation will occur via a third-party randomisation service, and study participants only will be blinded with regards to group allocation. A minimum of 162 participants to be enrolled over a 1-year recruitment period. All cases must satisfy the inclusion/exclusion criteria and will be followed for a minimum of 6 months after surgery.

Vulvovaginal symptoms affect up to 50% of post-menopausal women. Thinning of the vaginal lining following the sudden drop of oestrogen post-menopause potentiates symptoms such as vaginal burning, vaginal itching, vaginal dryness, dyspareunia and dysuria, which cause significant discomfort and impact the livelihoods of many women and their partners. First line treatments include topical vaginal moisturisers, lubricants and hormonal therapies; oestrogen hormone replacement therapy is indicated for systemic symptoms. However, patient compliance and efficacy are varied and limited, and some groups, namely women with a history of breast cancer or blood clots, are contraindicated to use of hormonal therapies. MonaLisa Touch (MLT) is a non-hormonal treatment of the vaginal lining, applying pin-point laser energy aiming to restore the skin to pre-menopausal state. The treatment is 5 minutes and claims to provide relief for vulvovaginal symptoms. Rapid uptake and FDA approval of the MLT procedure have proceeded on the basis of limited scientific evidence - only 2 prospective cohort studies, of a 12 week study period, exist to date. Therefore, it is necessary to produce high-quality scientific evidence, with a long-term follow-up of patients, to effectively determine the safety and efficacy of the MLT procedure in relieving vulvovaginal symptoms in post-menopausal women. This study is a randomised, double-blinded trial with a 12 month follow-up period, to evaluate the efficacy of intra-vaginal fractional carbon dioxide treatment for the treatment of post-menopausal vulvovaginal symptoms. The study will enrol a minimum of 78 patients, who will undergo three treatments, at least 4 weeks apart. Clinical follow-up will continue for a minimum of 12 months after the initial treatment with assessors blinded to the initial treatment type. Treatment outcomes will include: symptom intensity, Vaginal Health Index scores, Quality of Life scores, vaginal skin histology, treatment discomfort, treatment acceptability and treatment complications. Data from this study will allow patients and practitioners to make a more informed decision regarding treatment of these symptoms.

The aim of this clinical study is to investigate whether a new food supplement called Amixea can prevent or slow the loss of muscle mass and strength in patients with non small cell lung cancer undergoing chemotherapy. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with Stage III or IV unresectable non small cell lung cancer (NSCLC) for which you are undergoing, or plan to undergo chemotherapy. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will take a new food supplement called Amixea 3 times a day for 10 weeks. Amixea is a mixture of amino acids designed to prevent or slow the loss of muscle mass and strength in patients with cancer, particularly in those who show signs of cachexia. Participants in the other group will instead take a placebo (inactive) treatment for 10 weeks. The study will be double blind, which means that neither the patient nor the investigators will know which treatment the patients are receiving until after the study is completed. All participants will undergo a number of assessments before and after the 10 week treatment period, including dual-energy X-ray absorptiometry (DEXA) scans to evaluate body composition, muscle strength testing of the quadriceps (thigh muscles), and blood tests. They will also be asked to complete a number of questionnaires to evaluate nutritional status, quality of life, satisfaction with treatment, adherence and product tolerability. Results from patients treated with Amixea will be compared to those obtained from patients treated with placebo, in order to investigate the study product effects on cachexia.

Sarcopenic obesity is associated with an increased risk of frailty and loss of independence with advanced age. Management of sarcopenic obesity presents a complex challenge when prescribing dietary interventions; a conundrum is the potential harmful effects of energy restricted diets on the loss of skeletal muscle mass and the potential exacerbation of sarcopenia and associated functional decline. There is observational evidence supporting that higher intakes of fruit and vegetables and olive oil is inversely associated with muscle strength, physical performance and disability. Therefore, the aim of this study is to investigate the effects of diet induced weight loss on lean tissue mass in older overweight and obese adults. Moreover we aim to investigate the independent and combined effects of diet induced weight loss and carotenoid-rich fruit and vegetables plus extra virgin olive oil (EVOO) on body composition, muscle strength, physical performance, physical activity and quality of life in overweight and obese older adults.

The nature of training and competition in the majority of popular sports dictates that debilitating injury is not uncommon when individuals engage in high musculoskeletal loading patterns and/or high impact collisions. A consequence of such injuries is that repair and remodelling of tissues often requires significant periods of limb immobilisation. It is during immobilisation that normal mechanical loading of skeletal muscle is significantly reduced and muscle wasting (atrophy) ensues. Disuse atrophy is a secondary complication that exacerbates the aetiology of injury and complicates the return to appropriate quality and quantity of training. Better understanding of the genetic bases of disuse muscle atrophy in athletes following abrupt cessation of regular training and competition may ultimately result in improved countermeasures to mitigate short term muscle wasting. Specific strategies such as individualised nutrition and exercise rehabilitation to promote the prompt return of functional capacity may be entirely plausible with greater understanding of changes in inducible expression in skeletal muscle with shortterm immobilisation. The primary aim of the proposed study is to determine changes in inducible gene expression in the early (3 d) and short term (14 d) immobilisation period. The research question is novel and will have the capacity to inform sports medicine and exercise science in characterising individuals ‘at risk’ of rapid degeneration of muscle mass with disuse or those that may be “protected” from muscle loss with short term unloading. It is hypothesised that 14 days of limb immobilisation will modulate expression of the transcriptome in skeletal muscle and generate a distinct genomic profile associated with the early time course of muscle atrophy in healthy, young men.