Fishers

Researchers are studying the use of a chlorhexidine gluconate CHG-impregnated antimicrobial incise drape during primary hip or knee replacement surgeries. This clinical trial aims to evaluate the drapes performance and safety, focusing on contamination rates and operative characteristics during surgery. The study is prospective, single-arm, and conducted in the United States with adult participants aged 22 years and older. Participants will have the CHG-impregnated incise drape applied to the surgical site before the incision and it will remain in place for the entire surgery. The study focuses on patients undergoing unilateral primary hip or knee arthroplasty procedures. The device application and monitoring occur only during the surgical procedure. During surgery, samples will be taken from the operative site to assess possible bacterial contamination. Safety and intraoperative performance outcomes will be measured throughout the procedure. Participants must be able to provide informed consent and return for all visits. The study will be completed by October 2026, with the primary outcome being the presence of contamination at the surgical site during surgery.

Researchers are conducting a precision study to compare bone mineral density BMD measurements obtained from two low-dose x-ray exams using EOSedge biplanar full-body or full-spine imaging. The study aims to determine the measurement precision between the BMD assessments from these two exams. This single-center, prospective study involves 30 subjects who are indicated for radiography to evaluate spinal or other orthopedic conditions. Participants will undergo two EOSedge imaging exams during the study. The first exam is performed as part of their standard care, while the second exam is performed immediately afterward with repositioning between scans. The imaging outputs will be used for post-study calculations of BMD. Demographic and diagnostic information will be collected through case report forms, and subjects will complete a questionnaire based on international guidelines prior to the BMD scan. During the study, participants will be involved from consent through completion of both imaging exams. Researchers will review the precision of BMD measurements specifically for the spine and hip regions. Safety considerations include monitoring for any factors that may affect image quality or participant positioning. The study duration for each participant involves the imaging procedures on the same day, and data collected will inform the precision of BMD assessment using EOSedge technology.

Recent studies have found that many patients who suffer hip fractures from ground level falls may have undiagnosed cervical myelopathy, a condition where the spinal cord in the neck is compressed. This condition can impair balance and coordination, increasing the risk of falls and subsequent fractures. The study aims to screen patients with hip fractures to identify cervical myelopathy and help guide treatment to prevent future falls and fractures. Participants admitted to specific hospitals for hip fractures will undergo a detailed history and physical exam focused on detecting signs of cervical myelopathy. If the exam suggests this condition, patients will be offered a cervical spine MRI as part of their standard care to confirm the diagnosis. Those without signs of cervical myelopathy will not receive further evaluation for this condition during the study. During the hospital stay, study staff will review medical records to confirm eligibility, then perform the examination and history for research purposes. The main outcomes measured include detecting cervical myelopathy through exam and confirming diagnosis by MRI before discharge. The study involves a one-time evaluation at enrollment and follows patients until hospital discharge, with no long-term follow-up mentioned.

Researchers are evaluating the real-world clinical impact of the Galleri4, a blood-based multi-cancer early detection MCED test, in a Medicare population aged 50 years and older. This multi-center prospective cohort study aims to assess the tests safety and performance alongside usual care, enrolling participants representative of Medicare beneficiaries. The study is observational and compares outcomes between those receiving the Galleri test plus usual care and those receiving usual care alone. Participants in the Galleri-tested arm will have blood collected for the MCED test with results returned to guide further evaluation. The comparator group consists of Medicare beneficiaries receiving usual care without the Galleri test. Both groups will be observed over a period of up to 3 years to evaluate cancer incidence and diagnostic outcomes. Throughout the study, researchers will monitor the incidence of stage IV cancers, the number and types of invasive procedures following test results, adherence to recommended cancer screening, and healthcare resource use related to cancer diagnostics. Safety and test performance will be tracked in the Galleri-tested group. Participation involves routine clinical visits and data collection for up to 3 years, with no interventions withheld for either group.

Researchers are evaluating the Integrity Implant System in adults with rotator cuff tears of the shoulder. This study aims to confirm the devices performance, safety, and clinical benefit when used to augment rotator cuff tears, with or without repair. The trial focuses on reducing rotator cuff re-tear rates and improving shoulder function through a prospective, multi-center, single-arm, non-randomized post-market clinical follow-up. Participants will receive the Integrity Implant System during rotator cuff tear surgery, which may involve mini-open or arthroscopic approaches. The study will follow patients for up to 24 months after surgery, assessing repair integrity with MRI at 12 months and monitoring other functional outcomes and safety throughout the study period. During the study, participants will complete questionnaires measuring shoulder function, pain, and quality of life at screening, 6 weeks, 6 months, 12 months, and 24 months post-surgery. MRI scans will evaluate tendon repair quality and tissue regeneration. Safety will be tracked by recording adverse events. Participants need to follow rehabilitation instructions and attend all follow-up visits to support comprehensive evaluation of the implants performance.

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.