Hip Replacement – MASTER SL Clinical Study
The hip joint is a ball and socket joint. This is a research study evaluating the performance of a new hip replacement.
Status: in follow-up
The purpose of this study is:
- to generate data to evaluate Orthopaedic Data Evaluation Panel (ODEP) rating to support existing short-term clinical results and CE documentation;
- to assess the clinical performance of the MASTER SL femoral stem and the DELTA TT acetabular cup under standard conditions of use;
- to determine any adverse events and assess whether they constitute risks when weighed against the intended performance of the device.
Primary Outcome Measures: Rate of failure [Time Frame: 3 years]
Secondary Outcome Measures: Clinical progression measured with HHS score, OHS score, Non-Arthritic Hip Score, EQ-5D-5L [ Time Frame: from baseline to all time-points]
Other Outcome Measures: Any undesirable side effects [Time Frame: 3 and 5 years ]
Study start date: May 2014
Estimated study completion date: 2023
Sites
Royal Bournemouth Hospital NHS Foundation Trust (Lead Centre)
University Hospital Llandough Cardiff and Vale University Health Board
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust
Clinicaltrial.gov link: https://clinicaltrials.gov/ct2/show/NCT02126345?term=Master+SL&rank=1
