Wigan

Researchers are evaluating the accuracy of two diagnostic methods, percutaneous aspiration and open biopsy, for detecting infections around shoulder and elbow joint replacements, known as periprosthetic joint infections (PJI). This study aims to determine how useful pre-operative joint aspiration is for managing these infections. PJI is a serious complication that often leads to revision surgery in shoulder and elbow replacements, with diagnosis relying on a combination of clinical, laboratory, microbiological, histological, and radiographic information. The study compares tissue samples taken by open biopsy, the current gold standard usually done during surgery, with samples obtained through less invasive percutaneous aspiration. Aspiration helps identify bacteria and their antibiotic sensitivities before surgery but its accuracy varies, especially in shoulder and elbow cases where the bacteria involved may differ from lower limb infections. The study focuses on patients undergoing revision surgery for various types of shoulder and elbow arthroplasty, including total and hemiarthroplasties. Participants will be adults scheduled for revision shoulder or elbow replacement surgery who provide informed consent. Researchers will compare microbiological and histological results from both aspiration and biopsy over a 36-month period to measure diagnostic accuracy. The study excludes those who have not stopped antibiotics 2 weeks prior to procedures, pregnant individuals, and those involved in similar trials without agreement. Outcomes will help clarify the best approach for diagnosing PJI in upper limb arthroplasty patients.

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 prospective, observational registry includes patients who have undergone percutaneous coronary intervention (PCI) using this stent and are planned for a short dual antiplatelet therapy (DAPT) regimen lasting up to 3 months. The aim is to assess clinical outcomes in a real-world population across multiple countries and centers. Participants receive the Vivo ISAR stent and follow standard care with a short DAPT treatment of no more than 3 months after PCI. The study does not influence the choice of device or treatment beyond routine care. After the procedure, patients who meet eligibility criteria and provide consent are enrolled and observed over time without additional interventions. Participants will be followed up through routine clinical practice and telephone calls at 30 days, 3 months, and 12 months after PCI. These follow-ups collect information on ongoing medications, any lab tests performed, adverse events, and any further interventions. The main outcomes measured at 12 months include ischemic events and bleeding events related to the treatment and stent use.

Researchers are evaluating the efficacy, safety, and tolerability of two dosing regimens of itepekimab compared to placebo as an add-on treatment to intranasal corticosteroids in adult men and women with chronic rhinosinusitis with nasal polyps (CRSwNP). This multinational, randomized, double-blind, placebo-controlled Phase 3 study includes participants aged 18 years and older who have inadequately controlled CRSwNP. The study aims to better understand how these treatments impact nasal polyp symptoms and disease control over a one-year period. Participants will be randomly assigned to receive one of two dosing regimens of itepekimab or a placebo, all administered by subcutaneous injection. All participants will continue using mometasone furoate nasal spray as standard intranasal corticosteroid therapy. Treatment will last up to 52 weeks, followed by a 20-week safety follow-up period. The study includes a total of 9 site visits and 20 phone or home visits during the participant's involvement. Participants will be involved in regular assessments including endoscopic nasal polyp scoring and nasal congestion symptom evaluations at baseline and throughout the 24 weeks, among other time points. Researchers will monitor changes in nasal polyp scores and nasal congestion scores to measure the treatment effects. Safety and tolerability will be closely followed during the treatment and safety follow-up periods, with total participation lasting up to 76 weeks for most participants, or 56 weeks for those transitioning to an extension study.

Researchers are evaluating whether avoiding further axillary treatment after neoadjuvant chemotherapy (NACT) is as effective as standard axillary treatment for patients with early stage breast cancer who initially had cancer in the lymph nodes confirmed by needle biopsy but show no residual cancer in the lymph nodes after NACT. The study aims to determine if skipping axillary lymph node dissection (ALND) or axillary radiotherapy (ART) affects disease free survival (DFS) and whether it reduces the risk of lymphoedema five years after treatment. This phase 3, open-label, randomized trial includes patients with T1-3N1M0 breast cancer and confirmed nodal metastases who have undergone sentinel node biopsy removing at least three lymph nodes post-NACT.

Researchers are evaluating the safety and performance of the Zimmer Nexel Total Elbow device when used for primary or revision total elbow replacement. The study focuses on confirming the device's safety and effectiveness by analyzing standard scoring systems, radiographs, and records of adverse events. Conditions studied include elbow joint destruction, post-traumatic lesions, arthritis types, joint instability, and related elbow injuries. The study involves the use of the Zimmer Nexel Total Elbow device during elbow replacement surgeries. Both primary and revision total elbow arthroplasty procedures are included. The device's performance is assessed through various measures such as pain relief, functional outcomes, implant survival, patient health status, and radiographic success. Safety is monitored by tracking the frequency and incidence of adverse events related to the device. Participants will undergo scheduled follow-up evaluations to monitor outcomes over time. Researchers will collect data including pain and function scores, radiographs, and adverse event reports. The primary outcome measured is the 10-year survivorship of the implant. The study includes both retrospective patients who received the Nexel Total Elbow since July 2013 and prospective patients who will receive the device during the study period.

Tennis elbow, also known as lateral epicondylitis, is a common arm problem caused mainly by overusing the muscles that extend the wrist. Pain occurs where the tendons attach to the lateral epicondyle of the humerus. There are several treatment options including medication, physiotherapy, and injections, with surgery reserved for severe cases. Research suggests physiotherapy may be better long-term than corticosteroid injections, and some injections like Platelet Rich Plasma (PRP) and Hyaluronic Acid might relieve pain more effectively than corticosteroids. However, the best treatment approach is still unclear, so this study aims to compare the effects of injection therapy combined with physiotherapy to physiotherapy with a control injection on pain and arm function in people with tennis elbow. Participants will all take part in a structured class-based physiotherapy program and will be randomly assigned to receive one of three injections: a control injection where a needle is inserted but no medicine is given, a single injection of Platelet-Rich Plasma, or a single injection of Hyaluronic Acid (Ostenil Tendon). The injections will be done under ultrasound guidance to ensure accuracy. Blood will be drawn from all participants to help keep the study blind, with only the PRP group receiving processed blood injection. After the injection, participants will start home exercises and attend physiotherapy classes every two weeks to strengthen their wrist and arm muscles. Participants will be assessed before treatment and then again at 3 months and 12 months after injection. They will complete questionnaires on pain and arm function, including the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score, which is the main measure of improvement. Pain diaries will be used to track pain changes shortly after treatment. Some participants may be contacted by phone if they cannot attend follow-up appointments. The study will monitor pain relief, function, medication use, and overall outcomes to better understand the effectiveness of these injection treatments alongside physiotherapy for tennis elbow.

Researchers are evaluating the safety and effectiveness of whole-body hypothermia treatment in newborn babies diagnosed with mild hypoxic ischaemic encephalopathy (HIE). This phase III randomized controlled trial aims to determine whether cooling babies to 33.57b0C within six hours of birth for 72 hours improves cognitive development at two years of age compared to maintaining normal body temperature (normothermia). The study also assesses the cost-effectiveness of cooling therapy to help guide national and international treatment guidelines and standardize care across the NHS. Babies born at or after 36 weeks with specific signs of birth asphyxia or acidosis are randomly assigned to either whole-body hypothermia or targeted normothermia groups. The hypothermia group will have their body temperature lowered and maintained at 33.57b0C using a cooling machine for 72 hours in a neonatal intensive care unit. The normothermia group will have their temperature maintained at 377b0C with treatment for any fever using standard protocols. If babies in the normothermia group develop seizures and worsen to moderate HIE, they may receive cooling treatment as part of clinical care. Conventional MRI scans will be performed before discharge. Participants will be followed up at 24 months of age (7 months) using the Bayley Scales of Infant and Toddler Development IV to measure cognitive, language, and motor skills. Additional neurological exams, including assessments for cerebral palsy, vision, and hearing, will be conducted. Parents will complete questionnaires about their child's development. Researchers will collect detailed clinical data from birth through follow-up to evaluate safety and developmental outcomes. Babies who die or cannot complete assessments due to severe disability will be assigned specific scores to reflect outcomes.

Over 18 million adults in the United Kingdom experience significant hearing loss, which is associated with social isolation, depression, and other health conditions. Hearing aids are the main treatment option, but many users either do not use them or use them irregularly, reducing their benefits and increasing healthcare costs. This study aims to test an NHS-endorsed text-messaging system called Florence to support new hearing aid users, focusing on improving adherence, outcomes, and cost-effectiveness through a feasibility trial with proof-of-concept and process evaluation. The study uses a standardized audiology text-message protocol delivered through Florence, designed to prepare, inform, and support new NHS hearing aid users as they receive and start using their hearing aids. This behavioral intervention will be tested in adults aged 18 years and older who are prescribed their first NHS acoustic hearing aids for hearing loss. Participants will receive messages to help them manage their hearing aids between appointments. Participants will be monitored from enrollment through weeks 16 and 28, reporting their hearing aid use and completing the Glasgow Hearing Aid Benefit Profile at specified times. The study will assess the feasibility of the trial, the effectiveness of the text messaging in improving hearing aid use, and gather feedback on the process. This evaluation aims to enhance hearing aid adherence, improve quality of life, and reduce NHS costs over time.

Researchers are studying patients with chronic lymphocytic leukaemia (CLL) who are treated with acalabrutinib in the United Kingdom. This observational research looks back at real-world clinical outcomes for patients who started acalabrutinib through the UK's Early Access Programme (EAP). The study aims to describe characteristics of these patients and estimate progression-free survival, overall survival, response rates, treatment patterns, and healthcare resource use. The study focuses on patients who began first-line treatment with acalabrutinib between April 1, 2020, and April 1, 2021. It collects clinical data from patients' medical records in accordance with local laws. This non-interventional study does not assign treatments but observes outcomes from the use of acalabrutinib as provided in routine care. Participants' medical records will be reviewed to assess progression-free survival at multiple time points up to five years, along with other outcomes such as overall survival and treatment responses. The study also evaluates healthcare resource use and post-progression treatments. By gathering this data, researchers aim to provide useful real-world evidence on acalabrutinib's use in the UK for patients with CLL over the course of their treatment.

This research aims to assess the safety and performance of the commercially available PERFORM174 Humeral System, a device used for total or partial replacement of the shoulder joint. The study focuses on patients with shoulder conditions such as osteoarthritis, avascular necrosis, post-traumatic arthrosis, and rotator cuff tear arthropathy. It is an international, single-arm, multicenter, prospective, non-significant risk, post-market clinical follow-up study designed to gather data over a long period. Participants will receive the PERFORM174 Humeral System prosthesis, which is a non-constrained device intended for shoulder joint replacement. The study will collect data at baseline, during surgery, immediately after surgery, and annually for up to 10 years after the operation. This allows researchers to monitor the device's performance and safety over time in real-world use. Throughout the study, participants will undergo various assessments including patient-reported outcome measures related to quality of life, pain, and functional improvements, as well as radiographic evaluations. Data collection includes safety monitoring and performance evaluation at scheduled visits up to 24 months post-operation and beyond. The main outcome measured is the change in ASES scores from baseline through follow-up visits. This comprehensive follow-up aims to support post-market surveillance, educational materials, regulatory submissions, and further product development.