Long-Term Safety and Performance Study of Hip Hemiarthroplasty Using Corin BiPolar-i Shell and Oceane or Meije Duo Femoral Stems

What this Trial Is About

Researchers are conducting an observational study to gather long-term safety and performance data on hip hemiarthroplasty surgeries using Corin BiPolar-i shell along with the Oceane or Meije Duo femoral stems. This study responds to the need for more clinical evidence under the new Medical Device Regulation MDR for these Corin devices in hip hemiarthroplasty. The study focuses on patients with conditions like osteoarthritis, avascular necrosis, femoral neck fractures, and related hip disorders where only half of the hip joint is replaced. Participants undergo hip hemiarthroplasty surgery with Corin devices including the BiPolar-i shell and either the Oceane or Meije Duo cemented femoral stems. The study follows these patients for up to 10 years to collect comprehensive data on device safety and how well the devices perform in supporting mobility and quality of life. This includes radiographic assessments to monitor bone and device status, such as acetabular erosion, femoral stem stability, and bipolar head migration. During the study, participants will attend scheduled follow-up visits extending up to 10 years after surgery. Researchers will evaluate safety outcomes primarily at 2 years and continue monitoring mid- and long-term safety and device benefits up to 10 years. Data collection involves clinical examinations, radiographic imaging, and patient-reported measures of mobility and quality of life. The study aims to provide valuable information on the performance of these hip devices over time, ensuring ongoing safety and patient wellbeing.

Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty