Assessing the optimal follow-up regimen in metal-on-metal hip patients
Research type
Research Study
Full title
A prospective longitudinal cohort study assessing the optimal follow-up regimen for metal-on-metal hip resurfacing patients
IRAS ID
173325
Contact name
David W Murray
Contact email
Sponsor organisation
Joint Research Office, Oxfor University Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
How should we follow-up patients with metal-on-metal hip resurfacings?
Over one-million patients worldwide have received metal-on-metal hip replacements for arthritis. These devices are failing early and at high rates. Abnormal reactions to metal can develop which may be painful, and require further operations. Patients do poorly after further surgery which is concerning given most patients are young and active.
To identify problems early, most metal-on-metal hip patients are reviewed annually with many investigations including blood tests and hip scans. However, this follow-up is not based on any good evidence. Therefore it is not clear how best to follow-up patients. Many of these tests and appointments may be unnecessary which cause patient anxieties and concerns, especially in those without pain.
This research will provide evidence regarding which metal-on-metal hip resurfacing patients need follow-up, and which tests are required. This will reduce patient concerns, and by seeing fewer patients there will be significant cost savings.
In 2008, 158 metal-on-metal hip resurfacing patients with no pain had blood tests for metal levels, hip questionnaires, hip x-rays and ultrasound scans. These tests will be repeated a minimum of seven-years later to determine how results change over time. Hip x-rays and ultrasound scans are currently part of locally agreed routine care and will be organised by the patient’s hip surgeon.
Patients from the initial study who have not undergone further hip surgery will be contacted with details of this study, and attend a 30 minute clinic appointment at the hospital where their surgery was performed. The appointment will involve confirmation of study participation, one blood test for metal levels, and completion of a hip questionnaire (to determine the severity of any hip pain and disability). Results from 2015 will be compared to those from 2008 to determine how best to follow-up metal-on-metal hip resurfacing patients.
REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/1196
Date of REC Opinion
10 Aug 2015
REC opinion
Further Information Favourable Opinion