Fishers

Researchers are studying the use of a chlorhexidine gluconate (CHG)-impregnated antimicrobial incise drape during primary hip or knee replacement surgeries. The goal is to collect data on how well this drape performs during surgery, especially in preventing bacterial contamination at the surgical site. This prospective, single-arm trial takes place in the United States and focuses on safety and intraoperative outcomes. During the surgery, the CHG-impregnated antimicrobial drape is applied to the skin before making the incision. This drape is designed to reduce bacterial contamination and is used specifically in lower extremity orthopedic surgeries like hip or knee arthroplasty. The study does not include a comparison group and monitors the drape's performance throughout the operative procedure. Participants will undergo their planned arthroplasty surgery with the drape applied and will have samples taken from the surgical site during the operation to check for contamination. Researchers will assess safety and how well the drape works during surgery. Participants need to be at least 22 years old and able to provide consent and attend all follow-up visits. The study focuses on contamination rates and operative characteristics during the surgery itself.

Researchers are conducting a precision study involving 30 individuals who require full-body or full-spine radiography using the EOSedge biplanar imaging system. The study aims to compare bone mineral density (BMD) measurements obtained from two low-dose x-ray exams to determine the precision between these assessments. This single-center, prospective study focuses on subjects indicated for EOSedge imaging, often related to spinal or orthopedic evaluations. Participants will undergo two EOSedge imaging exams consecutively during the same visit. The second exam will be performed immediately after the first, with the participant being repositioned between scans to mimic typical clinical procedures. These exams will capture images for later analysis of bone mineral density and spinal or postural alignment. During the study, subjects will provide demographic and diagnostic information through specific case report forms and complete a questionnaire aligned with bone mineral density scan guidelines. Researchers will monitor the precision of BMD measurements within one day. The entire involvement spans from consent through completion of both imaging exams and data collection.

Recent studies have shown that many patients who suffer hip fractures from a fall at ground level may have undiagnosed cervical myelopathy, a condition where the spinal cord in the neck is compressed. This condition often leads to problems with balance and coordination, increasing the risk of falls and fractures. The study aims to screen patients with ground level fall hip fractures for cervical myelopathy using patient history and physical exams, and then offer cervical MRI scans if signs of the condition are found to improve diagnosis and treatment pathways. Patients admitted to Methodist, IU North, or Eskenazi hospitals with hip fractures caused by a ground level fall will be evaluated. The research team will perform a history and physical exam to check for signs of cervical myelopathy. If the exam suggests the condition, an MRI of the cervical spine will be scheduled as part of standard care. This process helps ensure a complete diagnosis and may lead to referrals for specialized treatment to help prevent future falls. Participants will be involved during their hospital stay, where the study team will review their medical history and conduct physical examinations. The main outcomes measured are identifying cervical myelopathy through history and physical exam at enrollment and confirming diagnosis with cervical MRI before hospital discharge. This screening and diagnostic process aims to detect cervical myelopathy early in this high-risk group to help guide future fall prevention efforts.

Researchers are evaluating the Galleri4 multi-cancer early detection (MCED) test in a multi-center prospective cohort study involving the Medicare population aged 50 years and older. This study aims to understand the real-world clinical impact of the test, including its safety and how well it detects cancers early. The study seeks to enroll participants who represent the Medicare population, including those with Traditional Medicare or Medicare Advantage coverage. Participants in the study are divided into two groups: one group receives the Galleri test through blood collection and multi-cancer early detection testing with return of results, while the other group receives usual care without the Galleri test. The study excludes individuals who have previously had an MCED test, are undergoing clinical evaluation for suspected cancer, have certain recent or untreated cancer histories, are pregnant, or are currently inpatient at a participating site. The study is designed to monitor participants over time without specifying a maximum age limit. During the study, researchers will track the incidence rates of stage IV cancers over a period of up to 3 years. Participants will be monitored for safety and test performance outcomes. The study involves informed consent from participants who are capable of providing it directly, and it excludes those who cannot comply with study procedures or who are not registered patients at participating centers. This research aims to provide data on the effectiveness and safety of the Galleri test in a real-world Medicare population setting.

Researchers are evaluating the Integrity Implant System for use in rotator cuff tear augmentation, with or without repair, in adults with rotator cuff tears of the shoulder. This prospective, multi-center, single-arm, non-randomized post market clinical follow-up study aims to confirm the device's performance, safety, and clinical benefit. The study focuses on the absence of rotator cuff re-tears and assesses functional outcomes and repair quality using standard scoring systems and MRI evaluations at 12 months post-surgery. Participants will receive the Integrity Implant System during rotator cuff surgery, which may be performed using mini-open, single-portal arthroscopic, or multi-portal arthroscopic techniques. The device is applied to support tendon repair, using fixation methods such as the Integrity Tissue Tack and Integrity Bone Staple. The study monitors the repair integrity, tendon tissue thickness, and regeneration over time. Throughout the study, participants will undergo various assessments including functional scoring (ASES, CMS, SANE, VAS), patient satisfaction surveys, quality of life measures (EQ-5D-5L), and MRI scans to evaluate tendon repair success and safety. Adverse events will be tracked to assess safety. Participants must complete all follow-up visits and rehabilitation as prescribed, with total monitoring extending to at least 12 months after surgery.

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.

Researchers are evaluating the safety and effectiveness of up to two injections of REACT/rilparencel in adults with type 2 diabetes mellitus and chronic kidney disease. This phase 3 randomized controlled study divides participants into two groups to compare the effects of the actual treatment versus sham procedures mimicking kidney biopsy and injections. The goal is to monitor kidney function and clinical outcomes over time to understand the impact of this therapy on disease progression. Participants are randomly assigned before a kidney biopsy to either receive sham procedures or the real treatment involving a kidney biopsy followed by two rilparencel injections about 12 weeks apart, each into different kidneys. Those receiving sham procedures will undergo similar-sounding and looking activities without actual tissue removal or injection. All participants will be followed until the study's global end date, ensuring consistent long-term observation. During the study, participants will undergo kidney biopsies or sham procedures, followed by injections or sham injections. Researchers will assess kidney function by measuring the slope of estimated glomerular filtration rate (eGFR) over 18 months after the 135th participant's first injection or sham procedure. They will also track clinical events such as significant kidney function decline, need for dialysis or transplant, or renal and cardiovascular deaths for up to 94 months. Safety and efficacy will be monitored throughout the study to evaluate treatment impact.

This research aims to compare the effects of usual care including regional radiation therapy with no regional radiation therapy in women with low-risk breast cancer. It focuses on patients with node positive breast cancer or T3N0 disease who typically receive endocrine therapy and possibly chemotherapy to prevent cancer recurrence. The study examines whether skipping regional radiotherapy still effectively prevents breast cancer from returning, potentially reducing unnecessary treatment and side effects. Participants will be divided into two groups: one receiving radiotherapy to the breast/chest area and surrounding lymph nodes, and the other receiving no regional radiotherapy. The study evaluates standard treatments, ensuring radiation therapy starts within specific time frames after surgery or chemotherapy. Treatments include breast-conserving surgery or mastectomy, along with endocrine therapy planned for at least five years. During the study, researchers will monitor breast cancer recurrence-free intervals over approximately 9.5 years. Participants will undergo regular assessments to track cancer status, side effects, and overall health. The study includes quality of life questionnaires for some patients and requires ongoing follow-up to document treatment effects, adverse events, and long-term outcomes.