Morton Grove

Researchers are evaluating the safety and performance of the Incompass Total Ankle System in patients undergoing total ankle replacement surgery. The study aims to measure improvements in quality of life and pain through patient-reported outcomes and medical imaging over a standard follow-up period. The device is FDA cleared and already used routinely in ankle replacement surgeries, so no experimental treatment is involved. Participants will undergo total ankle replacement surgery using the Incompass Total Ankle System and will be followed according to the surgeons standard care. Medical imaging such as X-rays and CT scans taken during routine care will be reviewed throughout the study. The main goal is to assess improvement in the Ankle Osteoarthritis Scale score at 24 months after surgery, along with other measures of safety, reoperation rates, radiographic assessments, physical and mental health questionnaires, and satisfaction with the ankle replacement. During the study, participants will complete questionnaires and undergo routine imaging at baseline, 6 months, 1 year, 2 years, and up to 10 years post-surgery. Researchers will monitor adverse events, survivorship of the implant, and functional outcomes over this period. The study is expected to enroll about 200 subjects over three years and continue follow-up for up to 10 years.

Researchers are evaluating the short-term and long-term effects and safety of belimumab in adults with early systemic lupus erythematosus SLE who have positive autoantibodies and ongoing disease activity despite stable first-line treatment. This is a prospective, open-label, single-arm Phase 4 clinical study sponsored by GlaxoSmithKline. The study focuses on adults diagnosed within two years with active SLE, aiming to better understand how belimumab works in this group. Participants will receive belimumab GSK1550188 administered subcutaneously throughout the study. The treatment and observation period lasts for three years, with key evaluations at one year and longer-term follow-ups up to three years. There is no placebo or comparison group, as all participants receive the study drug. During the study, participants will have regular visits to assess disease activity, including the Lupus Low Disease Activity State LLDAS at week 52 and other measures such as the SLE Responder Index 4 SRI4, flare frequency, and improvements in skin symptoms. Researchers will monitor safety by tracking adverse events and serious adverse events. Blood tests, questionnaires, and physical assessments will be done to evaluate fatigue, damage, and disease remission. Participants will be followed for up to 156 weeks to assess long-term outcomes and safety.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.