Lunel

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 conducting a global, single-arm, non-controlled observational study to assess the long-term performance, safety, and usability of Teknimeds range of sports surgery products. These devices, including bioabsorbable interference screws, pins, non-absorbable sutures, and anchors, are commonly used in orthopedic surgeries such as knee ligament reconstructions, shoulder repairs, and foot surgeries. This study aims to collect real-world safety and efficacy data to better understand these products behavior over time. The study involves patients undergoing orthopedic surgeries using various Teknimed devices like EUROSCREW NG, ISOFIX, SUTURLINK, ALINKS, and bioresorbable pins. Patients include those having surgeries on knee anterior and posterior cruciate ligaments, ankle, shoulder, and foot. The study collects data both retrospectively from surgeries performed since January 2016 and prospectively from patients planned for surgery with these products. Treatments are delivered as part of standard orthopedic surgical procedures. Participants will be followed according to local medical care standards, with assessments including joint function evaluation for up to 4 years and adverse event monitoring for 5 years. Secondary measures include pain levels, pain medication use, patient satisfaction, quality of life, radiological outcomes, and device usability during surgery. Data collection occurs during routine follow-ups and includes retrospective and prospective clinical information, ensuring comprehensive long-term monitoring of these orthopedic devices.