ANZCTR search results

Reverse total shoulder arthroplasty (rTSA) is widely performed for various shoulder pathologies has been shown to improve forward elevation and pain for most patients, but a subset of patients have persistent anterior shoulder pain and restriction in internal rotation. Emerging evidence suggests that increased tension or impingement of the conjoint tendon may contribute to this. Retrospective series have demonstrated improvement in symptoms following open conjoint tendon release, and recent biomechanical and clinical research suggests release may improve internal rotation and pain without increasing risk of complications. However, there is still a limitation in high-quality prospective trials which is crucial in establishing whether conjoint tendon release should be performed in rTSA. This study aims to demonstrate that conjoint tendon release at the time of primary rTSA improves postoperative pain, internal rotation and functional outcomes compared with standard rTSA without release.

This study aimed to investigate the safety and efficacy of coconut oil mouthwash in preventing and treating oral mucositis in children receiving cancer treatment. This study has completed recruitment. Who is it for? Participants in this study were aged 6 – 16 years, were receiving treatment for cancer and undergoing a chemotherapy cycle expected to result in a neutrophil count of <0.5x10^9/L. Study details Participants were randomly allocated (by chance) to one of two groups: one group used chlorhexidine 0.2% mouthwash, four times daily, over the course of one cycle of chemotherapy. The other group used virgin coconut oil mouthwash twice daily, in addition to four daily mouthwashes using chlorhexidine 0.2% mouthwash. Both groups completed a daily e-Diary for the duration of the cycle of chemotherapy. Both groups had mouth swabs taken before, during and after the chemotherapy cycle. It is hoped that this research will determine whether coconut oil mouthwash is a safe and effective prevention and treatment for oral mucositis in children receiving cancer treatment.

This study aims to monitor changes in activities such as eating and talking as well as quality of life measures for people with head and neck cancer who have undergone jaw reconstruction. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with head and neck cancer and you have either undergone or are planning to undergo jaw reconstruction surgery. Study details All participants who choose to enrol in this study will be asked to complete a series of surveys asking questions about their ability to eat different types of food (hard, soft, chewy, crunchy), how they feel their speech may or may not be impacted and any changes to their quality of life before and after undergoing jaw reconstruction surgery. Participants will be asked to complete the surveys at regular times in the first year following their surgery and then once a 20 minutes and this can be done via an online form. Participants may undergo jaw reconstruction planning using virtual surgical planning (VSP) if this is available at their hospital, or they may undergo traditional reconstruction surgery planning without VSP. Whether or not you choose to enrol in this study will not impact whether you are able to have VSP or not - these are determined by availability at the hospital you are attending. It is hoped this research will determine whether the use of VSP prior to jaw reconstruction surgery has an impact on the quality of life experience by people with head and neck cancer who have undergone reconstruction surgery; compared to people who underwent traditional reconstruction surgery planning without VSP.

This study is assessing the distribution of [203Pb]Pb-AB102 throughout the body and in advanced solid tumours using Single Photon Emission Computed Tomography (SPECT) imaging in participants diagnosed with advanced solid tumours. 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 a locally advanced or metastatic cancer, such as breast cancer or squamous cell carcinoma. Study details All participants will receive a single 15-minute intravenous injection of the study drug [203Pb]Pb-AB102 and may also receive an optional single 15-minute intravenous injection of the study drug [68Ga]Ga-AB101. Participants will then undergo Single Photon Emission Computed Tomography (SPECT) and Computed Tomography (CT) scans to determine the distribution of [203Pb]Pb-AB102 throughout the body and within tumours. If participants consent to the optional [68Ga]Ga-AB101 injection, they will also undergo Positron Emission Tomography (PET) and Computed Tomography (CT) scans to determine and compare the distribution of [68Ga]Ga-AB101 throughout the body and within tumours. Participants will be followed for at least 5 days after each study injection to assess any adverse events. It is hoped that this research will improve understanding of how [203Pb]Pb-AB102 distributes throughout the body and tumours, and whether it is safe for use in patients. In addition, researchers hope to determine whether [68Ga]Ga-AB101 can be used to identify patients who may benefit from a future therapeutic agent targeting the same cancer marker.

This study aims to determine whether catheter ablation improves cognitive function compared with optimised medical therapy in adults aged 67 years and older with persistent atrial fibrillation. Participants will be randomly assigned to receive either catheter ablation or guideline-directed medical therapy and followed for up to 24 months. Cognitive function will be assessed using validated neurocognitive assessments at baseline, 6, 12, 18 and 24 months, with cognitive function at 12 months as the primary outcome. Secondary outcomes include cognitive function at 6, 18 and 24 months, quality of life, atrial fibrillation recurrence and burden, healthcare utilisation, and safety outcomes. The study hypothesis is that catheter ablation will be associated with better cognitive function as compared with medical therapy alone.

The Evoke Spinal Cord Stimulator (SCS) System (Evoke System) is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs and will be used within its commercially approved indication. The purpose of this study is to evaluate the clinical utility of neurophysiological measurements of ECAP-controlled closed-loop SCS (i.e., neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs.

An open-label trial to investigate the use of vigabatrin to manage alcohol withdrawal in an outpatient setting. Participants will receive vigabatrin 2gm daily for four days, with regular assessments of withdrawal severity and benzodiazepine use. Follow-up will occur at 30 days post cessation of trial medication. We hypothesize that treatment of alcohol withdrawal with vigabatrin in a community setting is safe and tolerable.and will result in an overall use of diazepam of less than 100mg.

Excessive or prolonged foot pronation has been associated with increased mechanical loading of the lower limb and is associated with overuse injuries. Foot orthoses are commonly used to redistribute plantar pressures and modify lower-limb biomechanics, with anti-pronatory design features intended to reduce injurious loads associated with pronation by increasing medial ground reaction forces. However, conventional foot orthoses often produce inconsistent biomechanical outcomes, The research team has developed an approach to produce accessible and low-cost 3D-printed metamaterial foot orthoses with regionally graded stiffness that can precisely control mechanical properties across the device. These orthoses have the potential to provide more targeted anti-pronatory effects than conventional orthoses by selectively increasing medial stiffness while reducing material waste through additive manufacturing. This within-subjects randomised crossover study in healthy adults will compare the immediate biomechanical effects of 3D-printed metamaterial foot orthoses incorporating anti-pronatory graded stiffness with conventional prefabricated anti-pronatory and neutral foot orthoses. Primary outcomes will include plantar pressure distribution and lower-limb kinetics and kinematics during walking. The results of this study will provide insight into the biomechanical effects of graded metamaterial orthoses and inform larger clinical studies evaluating their effectiveness in people with pronation-related musculoskeletal conditions.

This study investigates whether adding a brief, single-session intervention before admission can improve outcomes for young people aged 16 to 21 entering a sub-acute mental health service. Participants will receive a pre-admission session based on either Motivational Interviewing (MI) or Dialectical Behaviour Therapy Pre-Commitment (DBT-PC), and their outcomes will be compared with those receiving treatment as usual. The study will examine whether these interventions increase motivation to engage in therapy, as well as actual engagement during admission, measured through attendance at group and individual sessions and completion of homework. It will also assess whether the interventions lead to better clinical outcomes, including reduced suicide risk, increased psychological growth, and fewer hospital bed days or emergency department presentations at discharge and follow-up. Finally, the study will explore how motivation and engagement interact to influence the relationship between pre-admission symptoms and discharge outcomes, helping to clarify the role engagement plays in young people's mental health recovery.

This is a randomised, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy of cannabidiol (CBD) compared with placebo in reducing alcohol consumption among adults with alcohol use disorder (AUD). Participants who have an Alcohol Used Disorder will be given bottles of CBD (or placebo) to take the recommended dose each day (a few drops, applied orally) for 12 weeks. Participants will attend for regular checks and drug dispensing during the treatment period. At Week 12, participants will have various checks to confirm whether drinking has reduced, again 12 weeks later an appointment will be held to check how participants have managed in the absence of the study drug .