South Kingstown

This study aims to collect prospective safety and effectiveness data for the C-Brace System, a microprocessor-controlled knee ankle foot orthosis, following standard care practices. The research focuses on patients with lower extremity pareses who are fitted with the C-Brace device. The goal is to better understand how the C-Brace influences walking speed, balance, risk of falling, and confidence in balance over time. The C-Brace is a custom-made device with thigh, calf, and foot components connected by an ankle joint or spring element. It uses sensors to continuously monitor knee joint movement and walking phases, adjusting hydraulic resistance and knee motion accordingly. Patients enrolled in the registry will undergo baseline evaluation, fitting, training or therapy sessions, and follow-up visits at 6, 12, 24, and 36 months after fitting. Participants will be assessed through various tests including timed walk tests, balance confidence scores, and mobility assessments at different intervals. The study also tracks falls related to device use and changes in activity levels with an activity tracker. Data collected will help characterize the safety and functional impact of the C-Brace over three years of follow-up.

Researchers are gathering information on the IlluminOss Device, which is used to stabilize and align bones in patients with traumatic or pathological fractures. This multi-center, observational patient registry aims to collect safety and performance data on this device as part of standard medical care. The study includes patients aged 50 and older who are candidates for the device. Patients who have received or will receive the IlluminOss Device are included in the registry. Data collection starts at the initial clinic visit and includes both prospective and retrospective entries. Medical details, surgical information, hospital discharge data, and any adverse events are recorded. Participants will complete patient-reported surveys such as PROMIS physical function, Visual Analog Pain Score VAS, and Veterans Rand 12 VR 12 before surgery and at 75 days, 6 months, and 12 months after the procedure. Throughout the study, patients will undergo scheduled clinical and radiographic evaluations to monitor outcomes. Researchers will track safety success rates, complications, device implantation success, fracture healing, disability, return to work status, discharge status, and patient-reported outcomes over 12 months. The study is designed to observe real-world use of the device and its effects on patient recovery and function over time.

This research aims to evaluate patient outcomes following shoulder replacement surgery using FX Shoulder Solutions medical devices. The study observes patients who have received these legally marketed devices in the USA to assess their safety, effectiveness, and long-term survivorship. The registry collects data to support regulatory requirements and share findings through presentations and publications. Participants are those implanted with FX Shoulder Solutions shoulder replacement devices, including various systems like Humelock II and Easytech Anatomical Shoulder System. The registry tracks these patients from surgery onward, with key follow-ups at 2 years to assess clinical success and up to 10 years to monitor device survivorship. Success is defined by measures such as improved shoulder function, no device migration, no revision surgery, and absence of serious device-related adverse events. During the study, patients undergo evaluations at multiple time points including 6 weeks, 3, 6, 12, and 24 months post-surgery using standardized scores like Adjusted Constant Score, QuickDASH, and Visual Analog Scale. Radiographic reviews, range of motion assessments, and tracking of adverse events and secondary surgeries occur up to 5 years. The study involves ongoing monitoring to understand the long-term performance and safety of the shoulder replacement devices.

This research aims to evaluate a technology-based collaborative care model called RI-SPHERES among postpartum patients with hypertensive disorders of pregnancy HDP. The trial will test whether RI-SPHERES is not worse than a standard self-measured blood pressure SMBP program in controlling persistent hypertension six weeks after delivery and improving preventive care attendance within one year. The study addresses challenges like low adherence to blood pressure checks due to barriers such as childcare and transportation, especially in racial or ethnic minority groups. Participants will be randomly assigned to one of two groups the RI-SPHERES group or the standard SMBP program group. The RI-SPHERES group will use a LTE-enabled blood pressure cuff syncing to a smartphone app that sends automated reminders and adaptive messages based on blood pressure readings and symptoms, with a nurse practitioner-led collaborative care team supporting patients. The first six weeks focus on blood pressure control, then shift to preventive care support for up to one year. The standard SMBP group will manually enter blood pressure readings into an electronic record to be reviewed by clinical staff, with recommendations for monthly blood pressure checks and preventive care after six weeks postpartum. Participants will be involved for one year postpartum, during which blood pressure measurements, preventive care visits, and maternal health outcomes will be monitored. Assessments include short- and long-term blood pressure control, severe maternal morbidity, emergency visits, hospital readmissions, medication adjustments, and patient satisfaction. The study will also evaluate equity in care related to race, ethnicity, language, and geography. Data will be collected through the app, electronic medical records, and regular communications with the study team to track adherence and health outcomes.