Trident II - HDFT

• Research type

  Research Study

• Full title

  Performance and Function of the Trident® II Acetabular Component - HDFT

• IRAS ID

  260313

• Contact name

  Jon Conroy

• Contact email

  jon.conroy@hdft.nhs.uk

• Sponsor organisation

  Harrogate and District NHS Foundation Trust

• Duration of Study in the UK

  11 years, 0 months, 1 days

• Research summary

  The purpose of this study is to evaluate the performance and function of the TRIDENT II Acetabular Component . The primary objective is to assess device survivorship, clinical outcome and patient satisfaction. All adverse events , failures or revision of the Trident® II components as well as liner revisions will be documented in order to draw Kaplan-Meier survival curves. Standard clinical parameters (PROMs: OHS, FJS, EQ5D) will be obtained to allow the surgeon to assess the clinical outcome as well as patient satisfaction.
  The study is aimed at patients aged between 40 and 75 years requiring an uncemented primary total hip replacement for osteoarthritis , avascular necrosis or post-traumatic arthritis. The study surveillance will last for 10 years.
  Clinical data will be collected pre , peri and post surgery. Participants will be asked to complete questionnaires on the pain and function of their hip before surgery and at 6wks, 1 , 3, 5 ,7 and 10 yrs post surgery.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  19/YH/0352

• Date of REC Opinion

  3 Jan 2020

• REC opinion

  Further Information Favourable Opinion