Morton Grove

It is anticipated that a total of 200 subjects will be enrolled at up to ten sites over a three year enrollment period. The study has been designed to follow the surgeon's standard of care for subjects treated with a total ankle replacement including imaging (x-rays and or CT scans). The primary endpoint of this study is the 24-month total Ankle Osteoarthritis Scale (AOS) score improvement after index surgery (or Initial Assessment). Secondary endpoints include safety (adverse events, reoperation, and survivorship) as well as performance measures (radiographic assessments, PROMIS Global Health questionnaire, Foot and Ankle Ability Measure \[FAAM\] and Total Ankle Replacement \[TAR\] Satisfaction questionnaires).

Researchers are evaluating the short-term and long-term safety and effectiveness of belimumab in adults diagnosed with early systemic lupus erythematosus (SLE) who have positive autoantibodies and continue to have active disease despite stable initial treatment. This phase 4, prospective, open-label study aims to describe how belimumab works in this specific group over a three-year period. Participants will receive belimumab (GSK1550188) administered by subcutaneous injection. There is one treatment arm where all participants will receive this drug. The study lasts for three years, during which participants will be regularly monitored to assess disease activity and treatment safety. During the study, participants will undergo various assessments including clinical evaluations to measure disease activity, laboratory tests, and questionnaires to track health status. The main outcome is the percentage of participants who achieve Lupus Low Disease Activity State (LLDAS) by week 52. Safety and efficacy will be closely monitored throughout the study period, with follow-up visits and evaluations scheduled at regular intervals.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.