BC Study of G7 cup used with compatible femoral stems
Research type
Research Study
Full title
A prospective, observational, multi-centre, cohort study of the G7™ acetabular system used with compatible femoral stems in patients with degenerative disease of the hip
IRAS ID
80596
Contact name
Robert Middleton
Contact email
Sponsor organisation
BIOMET GSCC BV
Duration of Study in the UK
11 years, 11 months, 30 days
Research summary
This study is a prospective, observational, multi-centre, cohort study of patients who have primary osteoarthritis of the hip and require Total Hip Replacement. The G7 Acetabular System will be used for the Total Hip Replacement, with various compatible femoral stems. The aim is to observe the rate of failure at 3, 5 and 10 years post-operatively to support the existing clinical results and CE documentation.
Male and female individuals aged over 18 years with a confirmed diagnosis of primary osteoarthritis who are suitable for primary total hip replacement will be potentially eligible to take part. This multi-centre study is being conducted at sites in England , Wales and Northern Ireland.
Following regulatory authority approval and completion of the informed consent process, participants will be reviewed pre and post-operatively and prior to discharge. They will then be required to attend on three further occasions for follow-up at 2-8 weeks (depending on routine practice at site) then at 1and 3 years. Participants will also be followed-up by phone at 6 months, and again at 5 and 10 years.. In total 480 participants will be involved in this study.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0225
Date of REC Opinion
12 May 2015
REC opinion
Further Information Favourable Opinion