Clinical Follow-up of ASR Patients Post-Recall v.2-0

• Research type

  Research Study

• Full title

  Clinical Follow-up of ASR Patients Post-Recall

• IRAS ID

  136643

• Contact name

  Ian Stockley

• Contact email

  ian.stockley@sth.nhs.uk

• Sponsor organisation

  Sheffield Teaching Hospitals NHS Foundation Trust

• Clinicaltrials.gov Identifier

  NCT01611233

• Research summary

  DePuy has issued a voluntary hip replacement recall on 96,000 ASR metal-on-metal hip implants due to a higher than acceptable revision rate reported in the England/Wales and Australian joint registries.

  In this research study, which is led from USA, Massachusetts General Hospital in Boston, USA will collect clinical information from 5,000 patients worldwide. The aim of this study is to document the long-term clinical outcome of the ASR Hip System and to improve the ASR patient treatment guidelines.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  13/LO/1915

• Date of REC Opinion

  10 Dec 2013

• REC opinion

  Favourable Opinion