Hip Replacement – Beyond Compliance Study of the G7 cup and compatible femoral stems
The hip joint is a ball and socket joint. This is a research study evaluating the performance of a new type of artificial hip socket.
Study Description
A prospective, observational, multi-centre, cohort surveillance study.
Primary Objective:
- To assess the clinical performance of the G7™ Acetabular System used with various compatible femoral stems under standard conditions of use;
Secondary Objectives:
- 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.
Number of Patients: 480 participants to be recruited (160 to Metal on Polyethylene (MoP) articulation, 160 to Ceramic on Ceramic (CoC) articulation, 160 to Ceramic on Polyethylene (CoP) articulation).
Status: Recruiting for MoP and CoC articulations. Recruitment for CoP articulation completed.
Study Duration: Recruiting: 2 years
Follow-up: 10 years
Study start date: November 2015
Estimated completion: November 2029
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
