Wigan

This research aims to compare how well two diagnostic methodspercutaneous aspiration and open biopsydetect infections in shoulder and elbow joint replacements that need revision surgery. Periprosthetic joint infection PJI is a serious problem leading to many revision surgeries, and early, accurate diagnosis is crucial but challenging. The study focuses on improving diagnosis methods specifically for shoulder and elbow PJI, as current evidence mainly comes from hip and knee replacements. The study observes patients undergoing revision surgery after shoulder or elbow arthroplasty. It compares the accuracy of pre-operative joint aspiration, which collects fluid samples, against open biopsy, which obtains tissue samples during surgery. Both microbiological and histological tests will be used to assess infection presence. The study follows participants for up to 36 months to evaluate the diagnostic accuracy of these methods. Participants will undergo standard clinical assessments, including laboratory tests of blood and joint fluid, microbiological cultures, tissue analysis, and imaging. Researchers will track infection detection and compare results from aspiration and biopsy samples. The main outcome is the diagnostic accuracy over 36 months, with additional culture analysis completed within 14 days. The study does not involve experimental treatments but focuses on improving infection detection before surgery.

Researchers are evaluating the safety and performance of the Polymer Free Sirolimus Eluting Coronary Stent Vivo ISAR in patients with coronary artery disease CAD. This observational registry focuses on individuals treated with this specific stent and planned for a short dual antiplatelet therapy DAPT of up to 3 months. The study aims to collect real-world data on clinical outcomes including safety and effectiveness over a 12-month period. Participants in this single-arm registry have undergone percutaneous coronary intervention PCI using the Vivo ISAR stent and will receive standard care short DAPT treatment for no more than 3 months. The study does not affect treatment choices or standard care procedures. After the PCI, eligible patients will be invited to join the registry and followed up at 1 month, 3 months, and 12 months. During the study, researchers will collect baseline medical data and conduct telephonic follow-ups at 30 days, 3 months, and 12 months. These follow-ups will check on medication use, laboratory assessments, adverse events, and any further interventions. The main outcomes measured include ischemic and bleeding events at 12 months, along with secondary outcomes such as mortality, heart attacks, strokes, stent thrombosis, and need for additional vessel treatments. The total participation duration is one year from the PCI procedure.

Researchers are evaluating whether skipping additional axillary treatment for patients with early-stage breast cancer who had cancer in their lymph nodes before chemotherapy but show no remaining cancer in those nodes after treatment is as effective as the standard approach. This study focuses on disease-free survival and reducing the risk of lymphoedema five years after treatment. It is a randomized, open, multicenter trial including patients with specific breast cancer stages and confirmed nodal metastases. Participants will all receive standard therapies including HER2-targeted treatment, endocrine therapy, and radiotherapy to the breast or chest wall if needed. They will be randomly assigned to one of two groups one group will not get further axillary treatment such as lymph node removal or radiotherapy, while the other group will receive these axillary treatments according to local guidelines. Follow-up visits will occur annually for at least five years. During the study, participants will undergo assessments to monitor disease-free survival and self-reported lymphoedema using specific questionnaires. Additional evaluations include arm function, quality of life, recurrence rates, survival, and cost-effectiveness analyses. The total study duration is planned for 120 months, including setup, recruitment, follow-up, analysis, and reporting.

Researchers are evaluating the safety and performance of the Zimmer Nexel Total Elbow device when used for primary or revision total elbow replacement. This study aims to confirm how well the device works and its safety by analyzing standard scoring systems, X-rays, and records of any adverse events. The study includes patients with various elbow conditions such as joint destruction, arthritis, instability, and fractures who require total elbow arthroplasty. Participants receive the Nexel Total Elbow device either as part of a primary or revision surgery. The study includes both retrospective patients who already had the device implanted and prospective patients who will receive it during the trial. The devices performance is assessed by measuring pain, function, implant survival, patient health status, and radiographic success over time. During the study, participants undergo scheduled follow-up evaluations to monitor outcomes and safety. Researchers collect information on device survivorship over a 10-year period using clinical assessments, imaging, and adverse event reports. The study involves non-randomized single-group participation without masking, with ongoing monitoring until study completion in 2036.

Tennis elbow, a common musculoskeletal condition causing pain at the lateral epicondyle of the humerus, is mainly due to overuse of wrist extensor muscles. Treatments vary from oral medications and physiotherapy to injections, with surgery reserved for resistant cases. This research aims to clarify the best approach by comparing physiotherapy combined with three types of injections for pain relief and function improvement in tennis elbow patients. Participants will all receive a structured, class-based physiotherapy program while being randomly assigned to one of three injection groups a platelet-rich plasma PRP injection, a sodium hyaluronate with mannitol Ostenil Tendon injection, or a sham injection that penetrates the skin but delivers no therapeutic substance. Injections are administered under ultrasound guidance, and the study is designed as a double-blind, randomized controlled trial. Throughout the study, participants will complete questionnaires including pain scales and functional assessments at baseline, 3 months, and 12 months after treatment. They will keep a pain diary during the first 12 weeks and be monitored for medication use and recovery progress. The main outcome is the change in Quick Disabilities of the Arm, Shoulder and Hand QuickDASH score at 12 months, supplemented by other measures of pain, function, and quality of life, all conducted under blinded evaluation.

Researchers are evaluating the safety and effectiveness of whole-body hypothermia for newborn babies with mild hypoxic ischaemic encephalopathy. This phase III randomised controlled trial aims to determine whether cooling the whole body to 33.5.5C within six hours after birth and continuing for 72 hours improves cognitive development at around two years of age compared with maintaining normal body temperature. The study also seeks to assess the economic value of cooling therapy for mild encephalopathy within the healthcare system. Babies born at or after 36 weeks with signs of birth asphyxia or acidosis will be randomly assigned to receive either whole-body hypothermia or targeted normothermia. Cooling will be applied using a servo-controlled machine in neonatal intensive care units, maintaining a rectal temperature of about 33.5C for 72 hours. The control group will have their body temperature kept at normal levels 37C for the first 80 hours, with any fever carefully treated. Babies born at non-cooling centers will be transferred to specialized units for treatment. During the study, participants will undergo brain monitoring, MRI scans before discharge, and follow-up developmental assessments at 24 months using the Bayley Scales of Infant and Toddler Development IV. Additional evaluations will include neurological exams, motor function assessments, vision and hearing tests, and parent-completed questionnaires. Researchers will collect detailed clinical data from birth through hospital stay, aiming to compare cognitive outcomes and safety measures between the two groups over the study period.

Hearing loss affects over 18 million adults in the United Kingdom and is linked to issues like social isolation, depression, and other health problems. Hearing aids are the main treatment but many users either do not use them or use them irregularly, which wastes resources and limits the benefits. This research is evaluating a standardized text-message support program delivered through Florence, an NHS-approved system, to help new hearing aid users improve their use, outcomes, and cost-effectiveness. The study compares two groups one receiving the usual NHS audiology care and the other receiving the same care plus a series of at least 65 supportive text messages over 14 weeks via the Florence system. The messages aim to prepare, inform, and support patients as they begin using their hearing aids. The study includes a pilot feasibility phase and a process evaluation to assess how well the program works and how it is received. Participants will be followed for 28 weeks and complete various questionnaires and assessments at different time points to measure hearing aid use, benefits, satisfaction, self-management, and quality of life. Researchers will also collect data logged by the text-message system. The study focuses on feasibility, proof of concept, and process evaluation, aiming to inform improvements in hearing aid management and support.

Researchers are studying patients with chronic lymphocytic leukaemia CLL who have been treated with acalabrutinib in the United Kingdom. This observational study aims to describe the characteristics and real-world clinical outcomes of these patients, especially those who started acalabrutinib treatment as part of the UK Early Access Programme. The study seeks to provide UK-specific data on how patients respond to and tolerate acalabrutinib in typical clinical settings. The study involves reviewing clinical records of treatment-naefve CLL patients who began acalabrutinib between April 1, 2020, and April 1, 2021. The focus is on patients treated in the first-line setting with acalabrutinib under the Early Access Programme. This non-interventional study does not involve new treatments but collects and analyzes existing data to estimate progression-free survival, overall survival, response rates, treatment patterns, and healthcare resource use. Participants medical information will be gathered from their clinical records following local laws. Researchers will track outcomes such as progression-free survival at various time points up to 60 months, overall survival, response rates, and treatment interruptions. The study design allows for long-term observation of how patients fare with acalabrutinib, providing valuable real-world evidence. The study is expected to continue through April 2027.

This research aims to collect safety and performance data on the PERFORM20 Humeral System, a device used for partial or total shoulder replacement in patients with conditions such as osteoarthritis, avascular necrosis, post-traumatic arthrosis of the shoulder region, and rotator cuff tear arthropathy. It is an international, single-arm, multicenter, prospective post-market clinical follow-up study designed to evaluate patient outcomes over time. The study focuses on patient-reported measures related to quality of life, pain, and function, as well as safety and radiographic assessments. Participants will undergo shoulder arthroplasty using the Tornier Perform Humeral Stem device. Data will be collected at baseline, during surgery, immediately after surgery, and then annually for up to 10 years post-operation. The study monitors the devices safety and performance through various assessments including patient satisfaction and radiological imaging throughout the follow-up period. During the study, participants will be assessed using patient-reported outcome measures such as ASES, Constant Murley, SANE, Subject Satisfaction, and EQ-5D scores from baseline through follow-up visits up to 10 years. Researchers will also track adverse events, revision surgeries, and imaging evaluations of the shoulder. The study involves long-term monitoring to understand the safety and effectiveness of the implant over time.

Researchers are evaluating the impact of two different default dialysate sodium concentrations on major cardiovascular events and death in adults receiving maintenance haemodialysis for end-stage kidney disease. This pragmatic, cluster-randomised, open-label Phase 4 study compares sodium levels of 137 mmoll and 140 mmoll in real-world dialysis settings across multiple sites globally. Dialysis sites will be randomly assigned to use either a default dialysate sodium concentration of 137 mmoll or 140 mmoll for at least 90% of dialysis sessions. Other aspects of patient care will follow standard local practices. Sites must consent to participate, and individual patients will provide waiver or opt-out consent. The study expects to enroll sites over 5 to 7 years, with each participant followed for approximately 2 to 5 years until the study endpoints are reached. Participants will receive dialysis at their assigned sites with the designated sodium concentration. Researchers will monitor the time to first occurrence of major cardiovascular events or death as the primary outcome. Secondary outcomes include other cardiovascular events and individual components of the composite outcomes. Data collection and patient monitoring will continue throughout the study period, estimated to last around five years per participant.