Abstract
Introduction
The need for the stringent surveillance of new devices was recognised by the NICE review of hip replacement surgery in 2000 and led to the Orthopaedic Data Evaluation Panel (ODEP) developing criteria for post-marketing surveillance (PMS) studies. This requirement has been reinforced by the recent recall of ASR devices.
Methods
The South West London Elective Orthopaedic Centre's (EOC's) comprehensive outcomes programme has been adapted to manage and coordinate multi-centre, multi-surgeon, PMS studies. The system allows any schedule and combination of patient-reported outcome measures (PROMS), clinical and radiological assessments, and complications to be collected. Typically, PROMS are collected pre-operatively and yearly by post. Baseline clinical assessment is undertaken pre-operatively, with baseline radiological assessments pre- and post-operatively. Subsequent clinical and radiological assessments are usually obtained at the ODEP-mandated time points of 3, 5, 7 and 10 years post-operatively. Patients are telephoned twice yearly to document complications and any impending change of address.
Results
EOC co-ordinated studies extend the ODEP criteria to provide high quality evidence on implant survivorship and patient outcome. In one study, over 500 subjects are under review. The operations were undertaken by twelve surgeons, at three centres. At 3 years participant withdrawal is 4%, mortality 4%, loss to follow-up 1% and revisions 0.5%. Average annual return of PROMS is 94%, and the percentage of invited patients returning for a 3 year review is 81%.
Discussion
The EOC system provides a cost-effective method for the long-term follow-up of implants through multi-site, multi-surgeon national, and international, PMS studies. Participation by high-volume centres facilitates both rapid recruitment of study participants and the infrastructure required to maintain consistent data quality. The acquired information gives timely information to surgeons, manufacturers and healthcare purchasers. We advocate adoption of the EOC PMS model for all new implants that are introduced to the UK market.
