Oswestry

This research aims to better understand the effects of nusinersen Spinraza4, a drug prescribed for spinal muscular atrophy SMA, on pregnant individuals with SMA and their babies. As treatment options allow people with SMA to reach pregnancy age, this observational study collects health information without changing medical care. The study compares pregnancy and birth outcomes among those exposed to nusinersen before or during pregnancy and those without SMA who havent received nusinersen. Participants include pregnant people with SMA from three SMA registries across different countries. The study observes those exposed to nusinersen within 14 months before the last menstrual period before conception, 14.5 months before conception, or anytime during pregnancy. Data is collected through registries, following participants until 3 months after delivery and their babies up to 2 years after birth. Participants provide health information each trimester, with doctors also contacted during pregnancy and after birth. Baby health is tracked at various ages up to two years. The study measures pregnancy losses, live births, birth defects, infant growth, and maternal and infant deaths up to 10 years. The overall study lasts at least 10 years from the first participants enrollment.

Researchers are evaluating the medicine surlorian in adults with autosomal dominant RYR1-related myopathy RYR1-RM, a genetic muscle condition. The study aims to find out if surlorian improves muscle weakness and to assess its safety and tolerability. This phase 2 trial involves adults aged 18 to 65 years who have confirmed genetic diagnosis and muscle weakness affecting proximal muscles. Participants will take part in a double-blind, randomized crossover study where they receive surlorian or a placebo once daily in two treatment periods separated by a washout. Each treatment period lasts about 16 weeks. After completing the main study, participants may join an optional open-label extension of about 12 months where everyone receives surlorian. During the study, participants undergo muscle strength and physical function tests like the 1-minute sit-to-stand test and 6-minute walk test. Researchers will also monitor blood pressure, blood tests, and adverse events for safety. The total study duration is approximately 68 weeks, including treatment and follow-up assessments to measure changes from baseline and evaluate tolerability.

Researchers are studying adults with Spinal Muscular Atrophy SMA to better understand how current care standards and new treatments affect the natural course of this genetic motor neuron disease. This observational study builds on previous efforts that gathered data from children with SMA and collaborates with several national and international SMA networks to improve patient care and support future research. The study is sponsored by Newcastle upon Tyne Hospitals NHS Foundation Trust and funded by Biogen and Roche. Participants are adults aged 16 and older with a genetically confirmed diagnosis of 5q SMA. The study collects data on patients receiving available SMA treatments such as Risdiplam and Nusinersen. There is no intervention or placebo instead, the study monitors and records patient outcomes over time to learn more about the disease and its management. During the study, participants undergo assessments every six months using several measures including the World Health Organization Motor Milestones, Revised Upper Limb Module, 6 Minute Walk Test, Hammersmith Functional Motor Scale Expanded, and the Egen classification 2 scale. These evaluations track motor function and disease progression. The study involves regular data collection from treatment initiation through study completion, helping researchers gather important long-term information about adult SMA.

This research aims to evaluate the effectiveness of a commercial robotic orthosis, also known as a robotic exoskeleton, for upper limb rehabilitation in patients with spinal cord injuries. The study focuses on tetraplegic inpatients with specific spinal injury levels and aims to assess improvements in arm function and independence. The study is conducted in two neuro-rehabilitation centers within the NHS in the UK, involving nine participants in total. Participants will undergo a twelve-week rehabilitation program using the Myomo robotic orthosis on their dominant arm, combined with their usual care and traditional rehabilitation. They will attend three to four sessions per week, each lasting about 45 minutes. The non-dominant arm will receive only the traditional rehabilitation, serving as a control for comparison. The study evaluates the use of this device alongside standard rehabilitation practices. Throughout the study, participants will be assessed at the start, midpoint 6 weeks, and end 12 weeks of the program. Measurements will include arm function, range of motion, spasticity level, and independence using clinical tools like the Spinal Cord Independence Measure version III SCIM III and others. Researchers will also gather feedback on patient and therapist satisfaction with the robotic device. The total participation duration is approximately 12 weeks, with ongoing monitoring of clinical changes.

Researchers are studying cells from tissues of juvenile patients and bio-banked cartilage to develop new treatments for cartilage and bone injuries and osteoarthritis. The study aims to find out which tissue sourcepolydactyly digit, iliac apophysis, or other bio-banked cartilageproduces better cartilage both in laboratory conditions and in living organisms. This observational study is conducted by clinicians and scientists experienced in cell-based therapies for cartilage and bone repair. Participants undergoing surgery for polydactyly will donate the waste tissue from digit amputation, and those having surgery for hip dislocation will provide a small piece of cartilage from the iliac apophysis. Additional tissues come from biobanks and the NHS Blood and Transplant service. The study focuses on evaluating cells from bone, bone marrow, cartilage, and possibly skin and fat, to assess their potential for musculoskeletal repair and allogenic cell therapy development. Participants provide tissue samples during their routine surgeries, with no additional interventions. Researchers assess cell viability up to 48 hours after collection and measure cartilage components such as glycosaminoglycan content over three months. The study involves analyzing these cells to better understand their potential for treating osteoarthritis and related injuries, with long-term monitoring planned until 2037.

This observational study evaluates the effectiveness of cell therapy for treating osteoarthritis. It compares patients who have undergone Autologous Chondrocyte Implantation ACI surgery with those who have not had this surgery to understand if surgical treatment of cartilage defects can prevent osteoarthritis later in life. Participants include a group who had ACI surgery at least 10 months before joining the study and a control group who did not have ACI. There are no drugs or other interventions involved as this is an observational comparison. Participants will complete a Cell Therapy Questionnaire at least fifteen months after their operation to assess outcomes. The study collects information to better understand long-term effects of ACI surgery on osteoarthritis progression. The total participation duration varies, and the research team will monitor responses to evaluate the effectiveness of cell therapy over time.

Researchers are investigating whether adding duroplasty, a surgical procedure that expands the tough membrane around the spinal cord, improves outcomes after severe cervical spinal cord injury. This trial focuses on adults with acute, severe injuries in the neck area who require surgery within 72 hours. The study aims to determine if duroplasty combined with standard bony decompression surgery enhances muscle strength and functional recovery compared to bony decompression alone. Participants will be randomly assigned to receive either standard spinal surgery including laminectomy alone or the same surgery plus duroplasty. Some patients may also join an optional mechanistic sub-study where probes and microdialysis catheters monitor spinal cord pressure, blood flow, metabolism, and inflammation at the injury site. The study will recruit around 222 to 260 patients over four years, including sites in the UK and internationally. During the study, participants will be assessed at baseline, 3, 6, and 12 months after surgery using questionnaires and physical examinations to measure muscle strength, hand function, walking ability, bladder and bowel control, and quality of life. Some will have MRI scans at 2 weeks and 6 months, and safety outcomes such as complications, additional surgeries, and mortality will be tracked up to 12 months. Follow-up lasts one year to evaluate recovery and treatment impact.

Researchers are evaluating the CartiONE technique combined with a biodegradable, biocompatible scaffold PolyActive for treating symptomatic focal cartilage lesions in the knee. This study collects retrospective baseline and follow-up data from patients treated with CartiONE between 2010 and 2023 across five countries to assess the clinical effectiveness and safety of this autologous articular-chondrocyte-based treatment. The study involves patients who received the CartiONE treatment more than six months ago. Data include patient medical histories, surgical reports, posttreatment observations, and any re-intervention records. The trial is retrospective, open-label, and single-arm, focusing on assessing treatment failure rates, adverse events, and cartilage defect volume fill via MOCART scoring over up to two years. Participants medical records will be reviewed for safety outcomes and cartilage repair quality, including effectiveness and quality-of-life questionnaires. The primary outcomes are adverse events and cartilage defect volume fill measured at multiple timepoints from baseline to two years. The study aims to combine questionnaire scores across patients and includes radiologists knee status assessments to support evaluation.

Researchers are studying osteosarcoma, the most common type of bone cancer, which affects people of all ages with peaks in adolescence and over 60 years. Despite various treatments like chemotherapy and surgery, survival rates have not improved much in the last 25 years. This study aims to collect detailed clinical data and biological samples to better understand how osteosarcoma develops, spreads, and responds to treatment, with the goal of improving care and developing new therapies. Participants will receive standard care treatments as determined by their doctors. This observational study does not prescribe any specific treatments but collects information on disease characteristics, treatment types, and patient outcomes. Blood and tissue samples will be gathered for laboratory analysis, while patient-reported outcomes and quality of life measures will also be collected to assess the impact of osteosarcoma and its treatments. Throughout the study, researchers will monitor clinical data, treatment responses, and laboratory findings to explore factors affecting disease progression and patient survival. Patient recruitment is planned over several years, with ongoing data collection and analysis. The study duration varies per participant, focusing on understanding osteosarcoma across all ages and tumor types to guide future clinical trials and improve patient support.

Researchers are evaluating the use of negative pressure wound therapy NPWT dressings in patients undergoing revision hip or revision knee surgery. This trial aims to compare wound healing and complications between two therapy durations 7 days versus 14 days. The study focuses on whether one week of NPWT is sufficient or if two weeks provides better outcomes, especially considering wound healing through old scar tissue in revision surgeries. Participants will be randomly assigned to receive either a 7-day NPWT PICO dressing and pump PICO 7 or a 14-day NPWT PICO dressing and pump PICO 14. The 14-day group will have a dressing change at one week, with the pump paused during the change and restarted afterward. Both revision hip and revision knee surgery patients will be included, with equal numbers in each group. Throughout the study, researchers will assess wound fluid leakage by grading staining on the dressings at one and two weeks post-surgery. They will also monitor for wound breakdown, discharge, and infections up to six weeks after surgery. Photographs will document wound appearance from surgery through follow-up visits. Participants must attend scheduled outpatient visits and follow instructions for study participation.