Status: In follow-up.
Study Description: This is a prospective, observational, multi-centre, cohort study of hip osteoarthritis patients who were due to undergo a total hip replacement. The G7™ acetabular system was used for the surgery, with various compatible 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.
Primary Objective: To assess the clinical performance of the G7™ Acetabular System used with various compatible femoral stems under standard conditions of use.
Secondary Objective: To generate data to evaluate Orthopaedic Data Evaluation Panel (ODEP) rating to support existing short-term clinical results and CE documentation. To determine any adverse events and assess whether they constitute risks when weighed against the intended performance of the device.
Study Start Date: November 2015.
Estimated Study Completion Date: November 2029.
Follow-Up: 10 years.
Number of Patients:
Study Sites: The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Bournemouth (Lead Centre)
Cardiff and Vale Orthopaedic Centre (CAVOC), University Hospital Llandough, Cardiff
Chapel Allerton Hospital, Leeds
Altnagelvin Hospital, Northern Ireland
Whittington Hospital, London
Registry Link: Study Details | BC Study of G7 Cup and Compatible Femoral Stems | ClinicalTrials.gov