Assessing Safety and Effectiveness of SYMBOL Medical Devices in Total Hip Replacement Surgery Over 10 Years

What this Trial Is About

Researchers are evaluating the safety and performance of the SYMBOL range of medical devices used in total hip arthroplasty hip replacement surgery. This observational study aims to monitor outcomes over a period of 10 years in patients who receive these devices, assessing their durability and overall impact on hip joint health. The study is sponsored by Dedienne Sante S.A.S. and focuses on conditions such as degenerative hip joint disease, post-traumatic osteoarthritis, hip arthritis, femoral neck fractures, avascular necrosis of the femoral head, and failure of prosthetic joint implants. Participants undergo total hip arthroplasty involving at least one medical device from the SYMBOL range. The study includes patients receiving either primary or revision hip replacement surgery with these devices. There is no randomized assignment or placebo group, as this is an observational follow-up of patients treated with SYMBOL devices. The study spans up to 10 years post-operation, with specific evaluation timepoints at 6 months, 18 months, 5 years, and 10 years after surgery. During the study, participants will have regular assessments including radiographic evaluations to check for implant stability and bone changes, as well as clinical evaluations using the Harris Hip Score and pain intensity scales. Patient-reported measures such as quality of life EQ-5D-5L and satisfaction with the hip joint will also be collected. The main outcome measure is the survivorship of individual SYMBOL orthopaedic components 10 years after surgery. Safety will be monitored by recording any adverse device effects throughout the study period, with follow-up lasting an average of 10 years.

Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty