MDR Vivacit-E Elevated Study

Launched by ZIMMER BIOMET ·

Keywords

ClinConnect Summary

This is an observational study looking at the long-term safety and performance of a specific hip implant liner called the Vivacit-E Vitamin E HXLPE Elevated Liners used in primary total hip replacement (hip replacement). Researchers will follow up with up to 52 people who had this liner implanted about 10 years ago to see how the implant has held up over time and how safe it is. The main goal is to see whether the implant remains in place without needing removal over 10 years, using standard methods to measure survival and any adverse events. They will also look at pain, function, and overall quality of life over the same 10-year period.

Eligibility is for adults 18 and older who had a primary hip replacement with the Vivacit-E liner for conditions such as osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital femoral epiphysis, a fused hip, pelvic fracture, or a diastrophic variant, and whose surgery occurred about 10 years ago (give or take a few months). People who had off-label use, active infection, a planned revision, certain cognitive or psychiatric issues, or difficulty following study requirements would not be eligible. If you participate, the team may review medical records and may ask about your current hip pain, daily functioning, and quality of life. The study is led by Zimmer Biomet and is based in South Bend, Indiana, with enrollment by invitation starting in 2025 and an estimated completion in 2027.

Gender

ALL

Eligibility criteria