G7 Acetabular System with Longevity/Vivacit-E Liners
Research type
Research Study
Full title
Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the G7® Acetabular System with Vivacit-E® and Longevity® Highly Crosslinked Polyethylene (HXLPE) Liners & Instrumentation
IRAS ID
300113
Contact name
Robert Middleton
Contact email
Sponsor organisation
ZimmerBiomet
Clinicaltrials.gov Identifier
Duration of Study in the UK
12 years, 2 months, 30 days
Research summary
The study is a global, prospective, multi-centre, non-randomized, non-controlled, dual cohort post-market clinical follow-up study. The study will have a maximum of 12 study sites globally, with up to 300 hips globally enrolled. This application is in regard to the UK site only, where the recruitment target is 25 participants.
The purpose of the study is to confirm the long-term safety, performance and clinical benefits of the G7 Acetabular Shells when used with the Vivacit-E and Longevity Highly Crosslinked Polyethylene (HXLPE) liners and instrumentation in primary and revision total hip arthroplasty (total hip replacement surgery). At the UK site, Longevity liners will be used.
Following regulatory authority approvals and completions of the informed consent process, participants will be assessed prior to hip arthroplasty surgery, intra-operatively, at discharge, at 6 weeks, and then at 1, 2, 3, 5, 7 and 10 years.
The primary endpoint is to assess whether the implant is still in place 10 years after surgery, and its safety will be assessed through the collection of data on any complications and readmissions. Data will also be collected on pain and functional performance and on quality of life. X-rays of the implants will be evaluated in the first five years.REC name
North West - Preston Research Ethics Committee
REC reference
22/NW/0168
Date of REC Opinion
8 Jul 2022
REC opinion
Further Information Favourable Opinion