Bloomington

This research evaluates the safety and effectiveness of the UrOActive4 Artificial Urinary sPHincter (AUS) for treating stress urinary incontinence (SUI) in men. It is a prospective, multicenter, single-arm study focused on men aged 22 years and older who have had SUI for at least six months. The study aims to assess outcomes related to the device's performance in this condition. Participants will receive an implant of the UrOActive4 AUS device. The study involves a single treatment phase where the device is implanted to manage urinary incontinence symptoms. There are no comparator groups, as this is a single-arm trial assessing the implanted device's safety and effectiveness. During the study, participants will be monitored for at least 26 weeks following device activation. Researchers will measure the responder rate at 26 weeks to evaluate the device's success. Participants will be assessed through clinical evaluations and monitored for any safety concerns or complications related to the implant and treatment.

Researchers are evaluating Rehabilitation with Exercise and Psychological Support (REPS), a combined exercise and psychological support approach during rehabilitation after anterior cruciate ligament (ACL) reconstruction. This pilot randomized controlled trial involves 60 patients aged 15 to 21 years with recent ACL reconstruction using specific graft types. The study aims to compare REPS with standard rehabilitation to determine if REPS improves psychological readiness to return to sport and knee function over six months. Participants are assigned to either REPS or standard rehabilitation groups. Both groups perform the same exercise program, but physical therapists providing REPS receive special training to offer enhanced emotional support. Participants in the REPS group also watch training videos on psychological recovery and mental skills, while the comparison group watches videos specific to their treatment. The study includes four visits over six months: before surgery, before the first post-surgery rehabilitation, and follow-ups at three and six months post-surgery. During the study, participants complete questionnaires assessing psychological readiness to return to sport, knee function, fear of movement, empathy, and therapeutic alliance at each visit. Researchers track treatment delivery and participant responses to evaluate the feasibility and acceptability of REPS. The total participation time spans six months, with assessments scheduled pre-surgery and throughout rehabilitation.

Researchers are investigating a new atrioventricular interval modulation (AVIM) algorithm within a dual-chamber Medtronic Astra/Azure pacemaker to see how it affects blood pressure control in people with hypertension. This multinational, prospective, randomized, double-blind clinical trial aims to evaluate the safety and effectiveness of the AVIM therapy, which is added to standard antihypertensive drug treatment. The study includes adults who either need or already have an Astra/Azure pacemaker implanted and have high blood pressure. The study has three phases: a screening phase, a double-blind randomized phase lasting one year, and an unblinded phase lasting two years. Eligible participants will have the AVIM algorithm downloaded into their pacemaker and be randomly assigned to either have the AVIM therapy turned ON or OFF. All participants will continue their prescribed blood pressure medications throughout the study. The study compares the effects of activated versus deactivated AVIM therapy on blood pressure. Throughout the study, participants will undergo various assessments including blood pressure monitoring to measure changes in average 24-hour ambulatory systolic blood pressure from baseline at three months. Safety is closely monitored by tracking any serious adverse effects related to the device. The total participation includes long-term follow-up over three years to evaluate both efficacy and safety of the AVIM therapy in managing hypertension alongside standard treatments.

The Helix Research Network (HRN) is a collaboration among academic, public, and private healthcare organizations focused on advancing medical research through large-scale genomics studies. The network aims to integrate genomic and other omics data into clinical care to better understand molecular and genetic factors related to disease risk, progression, treatment response, and other health outcomes. This research supports discovering new targets for treatment and improving diagnosis and medical care for individual participants. Participants in the HRN will provide samples for exome sequencing, which analyzes the protein-coding regions of genes. The network includes multiple member healthcare systems recruiting participants concurrently, potentially from various clinical sites. Enrollment continues until study withdrawal or end, with no fixed participant limit. The study includes ongoing sharing of individual genetic results with participants and annual reports on study findings and impacts. Participants will be involved in long-term follow-up, with data collection spanning an average of 10 years. Researchers will gather a large clinicogenomics dataset to explore genetic determinants of disease and collect patient-reported outcomes. The study also involves establishing a research network, aggregating data, and re-contacting participants for further studies. This long-term monitoring aims to improve understanding of genetic influences on health and support clinical implementation.

Researchers are evaluating the performance, clinical benefits, and safety of the Persona Revision Knee System in patients who have previously undergone primary or revision total knee arthroplasty (TKA). This study uses a multicenter, single-arm, retrospective cohort design with prospective follow-up to gather data. The study includes patients with knee conditions such as rheumatoid arthritis, osteoarthritis, traumatic arthritis, and other joint issues treated with this knee system. The study focuses on the Persona Revision Knee System implants and related devices used according to their instructions for use. Patients who had the system implanted will be identified retrospectively and invited for prospective follow-up visits at 1, 2, 3, 4, 5, 7, and 10 years after surgery. The device became commercially available in late 2019, so past treatments follow standard care. Up to 20 sites will participate with a maximum of 380 patients enrolled. Participants will attend scheduled follow-up visits involving clinical evaluations to measure knee function using the 1989 Knee Society Clinical Rating System objective knee score over 2 years. Researchers will monitor performance improvements, safety, and clinical benefits of the knee system. Data collection will help assess patient outcomes and device effectiveness with long-term monitoring planned up to 10 years.

Researchers are evaluating two different post-operative rehabilitation methods following reverse total shoulder arthroplasty (RTSA) in patients with shoulder osteoarthritis. RTSA has been effective for conditions such as rotator cuff arthropathy, fractures, and failed shoulder arthroplasty. The study aims to compare immediate active shoulder rehabilitation (IASR) starting from the first day after surgery to the traditional rehabilitation protocol that begins active motion around week 6, to assess outcomes, complications, and cost effectiveness over one year. Participants will be randomly assigned to one of two groups: the IASR group will start active shoulder exercises immediately after surgery, including four quadrant stretches and full active motion from day one in the hospital. The traditional rehabilitation group will follow a standard physical therapy protocol with a gradual return to active shoulder motion starting at week 6, including 18 physical therapy sessions. Physical therapy will be provided at the location most comfortable for the patient. Patients will be followed at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after surgery. Assessments include the American Society for Elbow and Shoulder Score, Simple Shoulder Test, PROMIS Global 10, and range of motion measurements. Researchers will monitor clinical outcomes, complications, and patient progress throughout the study to evaluate health improvements, patient experience, and cost effectiveness in line with the Triple Aim model.

Researchers are evaluating a care pathway aimed at preventing suicide attempts by connecting patients to behavioral health services right after their release from jail. The study focuses on harmonizing jail release records with electronic health records to improve suicide prevention and clinical care. It aims to assess the intervention's effectiveness on suicide attempts, behavioral health service use, and factors affecting implementation such as cost, scalability, and provider acceptance. Participants receive a coordinated care pathway that includes outreach contacts, suicide risk screening, safety planning, and connections to healthcare services if needed. The intervention also offers a virtual outreach component called the CLASP intervention. This care pathway is delivered at the time of jail release. During the study, participants' suicide attempts and deaths will be monitored for six months after release. Researchers will evaluate behavioral health service engagement and implementation aspects like cost-effectiveness and feasibility. The study includes adults released from jail between February 2021 and July 2028 who have prior healthcare visits within participating systems, and it involves follow-up using health records and jail data.

This research evaluates the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instruments in patients undergoing primary or revision shoulder arthroplasty. The study includes individuals with shoulder conditions such as fractures, arthritis, osteoarthritis, deformity, injuries, and pain. It aims to confirm these outcomes using standard scoring systems, X-ray evidence, and tracking of any adverse events related to the implants. Participants receive the Zimmer Biomet shoulder devices, specifically the Alliance Glenoid and Identity Stem, which are used in various types of shoulder arthroplasty including total shoulder replacement and hemi-arthroplasty. The study monitors implant survival over 10 years, looking at whether any implant parts need removal, while also analyzing safety by recording adverse events. Performance and clinical benefits, including pain, function, quality of life, and radiographic results, are assessed at 2 years post-implantation. During the study, participants will undergo regular assessments including clinical scoring, imaging, and safety monitoring to track implant survivorship and any complications for up to 10 years. Researchers will evaluate shoulder function, pain levels, and quality of life using established scores. Long-term follow-up ensures ongoing safety and effectiveness data are collected, supporting comprehensive understanding of the implant system over an extended period.