Long-Term Observational Study of Shoulder Surgery Using FH ORTHO Medical Devices for Trauma and Arthropathy

What this Trial Is About

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.

FH ORTHO Shoulder Observatory