Trident–Accolade THR with LFIT head and X3 poly surveillance study

  • Research type

    Research Study

  • Full title

    Proposal for investigation of early to medium term failures of Trident–Accolade Total Hip Replacement (THR) with LFIT head and X3 polyethylene liner.

  • IRAS ID

    171528

  • Contact name

    Richard Field

  • Contact email

    richard.field@eoc.nhs.uk

  • Sponsor organisation

    Epsom and St.Helier NHS Trust

  • Duration of Study in the UK

    1 years, 11 months, 16 days

  • Research summary

    THR design has evolved over the last six decades. Early hip replacements comprised two components. These were the femoral stem which provided the rounded head to articulate against the acetabular socket (cup). Such single piece implants were described as ‘monobloc’ components. Modern hip replacements comprise several parts that are fitted together during surgery. The stem (femoral component) has two parts. These are a metal stem which is inserted into the canal inside the upper part of thigh bone and a ball which is fitted onto a trunnion at the top of the stem.

    Over the last few years, there has been growing interest in the junction between the two parts of the femoral component and a number of investigators have identified that debris can be generated, at this interface, from processes known as fretting and corrosion.

    In May 2014 a number of lawsuits were filed in a New Jersey court claiming that the Accolade stem, in conjunction with the LFIT femoral head could be lead to excessive fretting, corrosion and toxic metal debris generation at the head trunnion interface.

    The research team at the South West London Elective Orthopaedic Centre (EOC) are organising a follow-up study of patients who already have the specific combination of components . These components are the Trident acetabular shell, Accolade femoral stem, LFIT head and X3 polyethylene liner. Our aim is to find out whether such implants are more or less vulnerable to early failure than other types of hip replacement.

    We propose a comprehensive investigation of to establish whether our patients are at increased risk of premature joint failure.

    The information collected during the study will increase knowledge of hip replacement outcomes. This may influence future thinking in hip replacement surgery. The information obtained from this study will help benefit patients in the future.

  • REC name

    London - Surrey Borders Research Ethics Committee

  • REC reference

    15/LO/0849

  • Date of REC Opinion

    18 Jun 2015

  • REC opinion

    Further Information Favourable Opinion