Henin Beaumont

Researchers are evaluating the long-term safety and effectiveness of commercially available Corin hip arthroplasty products. This observational study focuses on patients requiring hip replacement surgery due to conditions such as primary, secondary, or post-traumatic osteoarthrosis, femur head necrosis, congenital dislocations, and both primary and revision surgeries. The goal is to gather outcome data to support post-market surveillance and clinical evaluations over extended periods. Participants undergoing hip arthroplasty with Corin hip devices will be observed as part of this post-market clinical follow-up study. The study involves collecting data related to the performance and safety of these implantable devices during and after surgery. There is no experimental intervention, as the devices are commercially approved and already in use. Throughout the study, researchers will monitor participants' outcomes up to 10 years after surgery to evaluate the long-term success of the hip implants. Assessments include safety monitoring, performance reviews, and data collection to support peer-reviewed publications. Participants are expected to attend follow-up visits as part of the evaluation process to help document the implants' long-term effects.

Researchers are evaluating the long-term safety and performance of hip hemiarthroplasty surgeries using Corin BiPolar-i shell combined with the Oceane+ or Meije Duo femoral stem. This post-market clinical follow-up (PMCF) study aims to collect data over a period of up to 10 years to support the use of these devices, especially due to limited existing data under the new Medical Device Regulation. The study focuses on conditions such as hip fractures, osteoarthritis, avascular necrosis of the hip, and femoral neck fractures where the acetabulum does not require replacement. The study involves hip hemiarthroplasty, a surgical procedure replacing half of the hip joint with Corin devices. Participants receive the BiPolar-i shell and a cemented femoral stem, either Oceane+ or Meije Duo. The study tracks outcomes following these surgeries over an extended period, with data collection planned for up to 10 years to assess device safety and performance. Participants will be followed for safety evaluations, including clinical, radiographic, and patient-reported outcomes. The primary outcome measure focuses on device safety two years after surgery. Subjects must attend follow-up visits according to the protocol, and researchers will monitor their recovery, complications, and device performance throughout the study duration. The study includes adults of all genders clinically suitable for hip hemiarthroplasty with Corin devices and involves informed consent and compliance with study procedures.