Saint Jean

Non-muscle-invasive bladder cancer NMIBC is a type of bladder tumor that affects the inner lining of the bladder without invading the muscle layer. This research aims to collect and analyze real-world data on how NMIBC is managed and followed up in clinical practice across France. The study seeks to assess the performance of urine tests used to detect tumor recurrence and to understand variations in treatment and patient outcomes. The study is observational and involves collecting medical data from patients being monitored for NMIBC, including results from urine biomarker tests done before biopsies or resections. Urologists participating in the French Urology Association will record findings from regular bladder endoscopic exams and urine test results during routine care visits. Data analysis will focus on the accuracy of urine tests in predicting tumor recurrence and how this varies by tumor characteristics and prior treatments. Participants will have their medical history, treatments, and urine test results entered into a registry at enrollment. During follow-up visits scheduled as part of their personalized care, data on bladder exams and urine tests will be collected. Researchers will evaluate outcomes such as recurrence-free survival and the diagnostic value of urine biomarkers over a five-year period. The study plans to include around 8,000 patients over six years to improve understanding of NMIBC management and follow-up.

This research aims to evaluate a new care approach for men undergoing endoscopic enucleation of prostate adenoma using laser technology. Prostate adenoma is commonly managed with drugs or surgery, including laser treatments that help improve urination and quality of life. The study explores whether early supervised return home after surgery, supported by nurses, can safely reduce hospital stay without increasing serious complications. Participants will be randomly assigned to one of two groups an early home return group where nurses coordinate care before and after surgery to support patients at home, or a standard care group without additional support before or after hospital discharge. The laser surgery involves using specific wavelengths to remove the prostate adenoma via a fiber inserted through the urethra. The usual hospital stay is at least 48 hours, but this study tests reducing it to 24 hours with nurse supervision at home. During the study, researchers will monitor patients for re-hospitalizations or extended hospital stays within two weeks after surgery. Nurses will coordinate care and provide guidance to patients in the early return group, while all participants will be followed up to assess safety and recovery. The total participation includes the surgical procedure, hospital stay, and monitoring during the two-week period to evaluate outcomes and complications.

Hallux valgus is a common deformity of the forefoot that mainly affects women and requires surgical correction involving osteotomy of the first metatarsal and sometimes the first phalanx of the big toe. The study aims to evaluate whether adding self-rehabilitation through a connected application alongside traditional physiotherapy improves postoperative joint mobility compared to standard physiotherapy care alone. The trial focuses on patients undergoing isolated hallux valgus surgery with the goal of enhancing foot function and mobility. Participants undergo hallux valgus surgery followed by two different rehabilitation approaches one group uses a connected application to perform exercises at home in addition to physiotherapy sessions twice weekly for 10 weeks, while the other group receives only the standard physiotherapy care. The connected application is designed to reproduce continuous passive range of motion exercises outside of scheduled physiotherapy visits to improve foot mobility. During the 6-month study period, participants will have their metatarsophalangeal joint mobility assessed as the primary outcome. They will complete questionnaires such as EFAS, EVA, and EQ-5DL to monitor progress. The study evaluates whether self-rehabilitation using the app combined with physiotherapy leads to better mobility outcomes than physiotherapy alone, with assessments conducted at regular intervals throughout the recovery process.

Researchers are observing patients who have undergone shoulder joint replacement or repair after shoulder trauma. The study focuses on collecting long-term clinical data under usual surgical conditions and follow-up to evaluate the continued benefit and risk of specific medical devices used in these procedures. The study meets the post-market clinical follow-up requirements of European regulations and aims to include a large number of patients over 5 to 10 years depending on the device. The devices studied include CE-marked shoulder medical devices distributed by FH ORTHO SAS, such as the ARROW prosthesis, Telegraph Evolution humeral nail, and STRAPFLEX strapping system. Patients included have been treated with these devices either prospectively or retrospectively at participating centers. This is a non-interventional, real-life observational study designed for permanent long-term follow-up. Participants will be monitored through routine clinical follow-up visits and data collection over a period of up to 10 years. Researchers will evaluate the performance and revision rates of the medical devices during this time. Minimal clinical data and patient questionnaires will be collected as part of typical care to document device performance and safety. The study involves no experimental treatments and aims to understand device outcomes in usual practice.

Researchers are evaluating the use of virtual reality as a method to reduce pain during the endovenous thermal treatment of superficial varicose veins. The study aims to see if virtual reality sedation can delay the need for neuroleptanalgesia when combined with local anesthesia by tumescence. This is a prospective, randomized, open-label study involving 200 patients, focused on comparing pain intensity during surgery. Participants are divided into two groups one group receives local anesthesia by tumescence plus the usual neuroleptanalgesia treatment, while the other group receives local anesthesia with virtual reality software for sedation. The study tests if virtual reality sedation is not inferior to traditional neuroleptanalgesia by measuring maximum intraoperative pain. The entire participation lasts up to 2 days. During the study, pain is assessed immediately after surgery using a numerical rating scale. Researchers will also evaluate pre- and post-operative anxiety, overall patient satisfaction, surgery duration, ICU and hospital stay length, and time to resume normal activities. Safety and treatment details are monitored throughout, with the primary outcome focused on pain intensity on the first day.

Researchers are evaluating the performance and stability of the SMS femoral stem implant in patients who need total hip replacement due to conditions like osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head. This is a prospective, multicenter, open clinical study without randomization or control groups. The study is sponsored by Medacta International SA and aims to observe participants for up to 10 years to assess long-term outcomes. Participants will undergo Total Hip Arthroplasty using the SMS Femoral Stem by Medacta. The study will monitor the implants survival rate, clinical performance, hip function, quality of life, safety through adverse event tracking, and the implants stability and fixation over the 10-year period. There is no mention of different treatment groups or placebos, as this is an observational study focused on one specific implant procedure. During the study, participants will be regularly assessed for the durability and function of the SMS femoral stem, hip joint performance, and overall quality of life. Safety will be monitored by recording any adverse events. The total participation duration lasts from enrollment until 10 years after the procedure. Patients must comply with study requirements and provide informed consent, with ongoing follow-up to evaluate the implants long-term effects and stability.

This research focuses on adults undergoing surgery for rotator cuff tendinopathy and aims to understand how preoperative stress levels might affect postoperative recovery. The study explores the hypothesis that higher stress before surgery could lead to more severe complications, such as complex regional pain syndrome or adhesive capsulitis, which can prolong recovery and impact personal and professional life. Participants in this observational study will be assessed using questionnaires, including the MSP9 score, Cungi scale, and EVA scale, to measure stress levels before surgery. The research centers on patients having first-line surgery for rotator cuff tendinopathy, with no active treatment interventions being administered as part of the study. Throughout the study, participants will undergo stress assessments before surgery using established scales. Researchers will track stress levels to evaluate their association with postoperative outcomes. The main measurement is the preoperative MSP9 stress score, with data collection completed by September 2026. Participants usual care continues uninterrupted during the study.

Researchers are monitoring the performance of the GMK SpheriKA Knee Prosthesis implanted using the kinematic alignment technique in patients who need a primary total knee replacement. This post-marketing surveillance study aims to collect clinical and radiological data to better understand how this device performs over time in people with arthropathy and knee replacement needs. Participants will receive the GMK SpheriKA knee prosthesis through surgery using the kinematic alignment method. The study will follow patients from 6 weeks after surgery and then annually up to 10 years. During this time, various assessments including patient-reported outcomes, satisfaction questionnaires, radiological exams, and monitoring of adverse events will be collected at specific time points such as pre-operation, 6 weeks, 1, 2, 5, and 10 years. Participants will attend follow-up visits to complete questionnaires and undergo radiological imaging to evaluate joint function and alignment. The primary measure will be the Forgotten Joint Score FJS, assessed from 6 weeks post-surgery through annual visits for up to 10 years. Researchers will also track safety and performance through adverse event reporting and imaging studies. The total participation duration may last up to 10 years to fully capture long-term outcomes and device performance.