Oswestry

Researchers are studying how the drug nusinersen (Spinraza42), used to treat spinal muscular atrophy (SMA), affects pregnant people with SMA and their babies. Since people with SMA are now living longer and reaching childbearing age, this study aims to collect important information about pregnancy outcomes and baby health when nusinersen is taken before or during pregnancy. The study compares three groups of participants based on when they received nusinersen relative to pregnancy and also compares data to people without SMA who have not used the drug. This observational study collects health information without changing medical care. Participants are identified through three SMA research networks in the US, UK, and parts of Europe. Data collection begins when participants join and continues throughout pregnancy with contacts every trimester, around 6-7 months of pregnancy, and about 4 weeks after delivery. Babies are followed up through their doctors at ages 1, 2, 6, 12, 18, and 24 months. Each participant remains in the study until 12 weeks after delivery, and babies are monitored for up to 2 years. The entire study is planned to last at least 10 years from the first participant enrollment. Participants are monitored for pregnancy complications, birth outcomes, and any adverse effects in their infants related to nusinersen exposure. Researchers track pregnancy losses, live births, baby growth and development, and maternal and infant deaths. Information is collected from both participants and their doctors at multiple points before, during, and after pregnancy. The study measures these outcomes over up to 10 years to better understand nusinersen's effects on pregnancy and infant health in people with SMA.

Researchers are studying Spinal Muscular Atrophy (SMA), a genetic motor neuron disease that affects both infants and adults. This research focuses on understanding how current standards of care and new treatments impact the natural progression of SMA in adults. The study is supported by The Newcastle upon Tyne Hospitals NHS Foundation Trust and funded by Biogen and Roche, involving collaboration with international SMA networks to improve patient care and future research. The study collects data on adults with SMA who may be receiving treatments such as Risdiplam and Nusinersen. These drugs are among the therapies available in the UK, with Zolgensma being the only fully approved drug and others accessible through Managed Access Agreements. The research builds on previous efforts in pediatric SMA studies and aims to standardize data collection across sites to better track long-term treatment effects. Participants will undergo various assessments every six months, including motor milestone evaluations, upper limb function tests, walking tests, and functional motor scales. These measures help monitor disease progression and treatment impact over time. The study also involves collecting information on patient health and treatment experiences to inform clinical decisions. Participation requires informed consent, with ongoing data collection throughout the study period.

This research aims to evaluate the use of a robotic exoskeleton device for upper limb rehabilitation in people with spinal cord injuries, specifically those with tetraplegia. The study focuses on patients with certain levels of cervical spinal cord injury (C5 to C8) who have arm impairments and some preserved motor and sensory functions. The goal is to see if this commercial device, produced by Myomo, can help improve arm function and independence while complementing usual care. Participants will undergo a 12-week rehabilitation program using the Myomo robotic orthosis on their dominant arm. Sessions will be held three to four times a week, each lasting about 45 minutes, totaling up to 48 sessions. This device-assisted therapy will be provided alongside their standard rehabilitation. The study will take place in two neuro-rehabilitation centers in Scotland and England, involving nine spinal cord injured inpatients. Throughout the study, patients' arm function, range of motion, and spasticity levels will be measured before starting, halfway, and at the end of the program to track changes. Researchers will also assess both patient and therapist satisfaction with the device. The primary outcomes include changes in the Spinal Cord Independence Measure version III (SCIM III) at 6 and 12 weeks, reflecting improvements in functional independence and arm use.

Researchers are studying the potential of cells collected from different tissues to develop new therapies for cartilage and bone injuries, including osteoarthritis. The focus is on comparing cells from polydactyly digits, iliac apophysis tissue from hip surgeries, and other bio-banked cartilage to determine which source produces better cartilage both in the lab and in living organisms. This research is part of ongoing efforts at the Robert Jones & Agnes Hunt Orthopaedic Hospital to find better cell-based treatments for cartilage and bone damage. Participants undergoing surgery for polydactyly will be asked to donate the tissue removed during digit amputation, while those having surgery for hip dislocation will provide a small cartilage sample from the iliac apophysis. Additional tissues will be obtained from biobanks. The study aims to evaluate the ability of cells from these sources to form cartilage and bone, which could be used to treat patients with osteoarthritis or other injuries. During the study, researchers will assess the viability of the collected cells up to 48 hours after isolation using a trypan blue exclusion assay. The collected cells will be analyzed for their potential to develop into cartilage and bone tissues. Participants' involvement includes donating tissues during scheduled surgeries, with parental consent required for juvenile donors. The study also involves collaboration with biobanks and monitoring of tissue quality for future therapeutic use.

Researchers are evaluating the effectiveness of cell therapy as a treatment for osteoarthritis. This observational study focuses on patients who have cartilage defects and are receiving either autologous chondrocyte implantation (ACI) or an alternative treatment to understand whether surgical treatment can prevent osteoarthritis later in life. The study involves patients who have already undergone cell therapy or other treatments for cartilage defects. There are no specific interventions or treatment schedules detailed, as the study is observational and monitors outcomes following these treatments. Participants will be assessed at least fifteen months after their operation using a Cell Therapy Questionnaire to evaluate the long-term effects of the treatment. The study includes patients of all genders, with no age restrictions mentioned. Researchers will collect data to better understand the role of cell therapy in managing osteoarthritis over time.

Researchers are evaluating whether adding duroplasty, a surgical procedure that expands the dura (the tough membrane around the spinal cord), to standard spinal surgery improves muscle strength and outcomes after severe traumatic spinal cord injury in the neck. This condition often causes permanent disabilities like paralysis and loss of bladder and bowel control, and currently, no treatments have proven to improve recovery. The study focuses on adults with severe cervical spinal cord injury who need surgery within 72 hours of injury. Participants will be randomly assigned to receive either standard spinal surgery, which includes laminectomy (removal of part of the vertebra), or spinal surgery plus duroplasty. The duroplasty involves opening the dura and stitching a patch to relieve pressure on the swollen cord. A subgroup of patients will also take part in a smaller mechanistic study using probes at the injury site to monitor pressure, blood flow, metabolism, and inflammation. The study will recruit 222 adults over 4 years from major trauma centers in the UK. During the study, patients will be assessed at baseline, 3, 6, and 12 months after surgery for muscle strength, hand function, walking ability, bladder and bowel control, quality of life, complications, and survival. Some patients will have additional monitoring at the injury site. The main outcome measured is the change in motor function at 6 months compared to baseline. Participants will be followed for one year to evaluate recovery and safety.

Researchers are evaluating the long-term effectiveness and safety of the CartiONE technique in treating symptomatic focal articular-cartilage lesions of the knee. This study collects retrospective baseline and follow-up data from patients treated with CartiONE between 2010 and 2023 across five countries: Belgium, England, Greece, Poland, and Austria. The study aims to confirm the clinical outcomes and safety of CartiONE in real-world settings over a period ranging from 1 to 13 years. The CartiONE technique was originally evaluated in combination with a biodegradable, biocompatible, load-bearing copolymer scaffold in a prior trial. This study focuses on patients treated with CartiONE alone, with a minimum follow-up period of six months. Data include medical histories, operation reports, posttreatment observations, and any re-intervention reports collected as part of standard care at participating hospitals. Participants' medical records will be reviewed for safety outcomes, including adverse events and treatment failure rates, as well as effectiveness outcomes measured by the MOCART sub-score for cartilage defect volume fill at multiple time points up to two years. Additional assessments include quality-of-life questionnaires and radiologists' overall knee status evaluations. The study is retrospective, open-label, and non-randomized, involving up to 122 patients.

Osteosarcoma is the most common type of bone cancer, affecting about 130 people each year in England across all ages. Survival rates have not improved much in over 20 years, with about 42% of patients surviving five years after diagnosis. This research aims to gather detailed clinical information and biological samples from patients of all ages with osteosarcoma to better understand how the disease develops, spreads, and responds to treatment. The study also aims to learn how osteosarcoma and its treatments impact patients' lives to improve care and support. Participants will receive their usual care without any changes or new treatments from the study. Information collected will include details about the cancer's size, location, diagnosis, treatment types like chemotherapy and surgery, and responses to these treatments. Blood and tissue samples will be collected for laboratory analysis to explore the biology of osteosarcoma and identify factors that influence treatment outcomes. The study will include patients with various types of osteosarcoma, including those with metastatic disease and tumors in less common locations. During the study, researchers will collect clinical data and biological samples and monitor patient outcomes over time. The main measure is patient recruitment, tracked over one year in the initial phase and three years in the main study. Researchers will analyze the combined clinical and laboratory data to identify patterns that could guide future treatment trials. The overall goal is to improve osteosarcoma treatment and help patients live longer, healthier lives.

Researchers are comparing two treatment durations of negative pressure wound therapy (NPWT) for patients undergoing revision hip or knee surgery. This study focuses on whether a 7-day or 14-day application of NPWT dressings is more suitable for wound healing and prevention of complications in revision surgeries, which involve old scar tissues. The trial includes 82 participants for revision hip surgery and 82 for revision knee surgery, all under the care of participating orthopedic surgeons. Participants will be randomly assigned to receive either a PICO 7 dressing with NPWT for 7 days or a PICO 14 dressing with NPWT for 14 days, including a dressing change at one week for the 14-day group. After 7 days, the PICO 7 group will switch to a standard hydrocolloid or other dressing. The NPWT pump will be paused briefly during dressing changes and restarted afterward. This approach aims to assess the optimal duration of NPWT in revision surgeries. Participants will be monitored for wound healing progress and complications up to 6 weeks after surgery. Key outcomes include measuring wound exudate at 1 and 2 weeks, late wound discharge after therapy ends, and any wound infections, both superficial and deep. Study visits will be conducted at the outpatient department, with assessments including dressing evaluations and tracking of wound health and safety throughout the study period.