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Journal of Bone and Joint Surgery - British Volume, Vol 88-B, Issue 6, 716-720.
doi: 10.1302/0301-620X.88B6.17334  
Copyright © 2006 by British Editorial Society of Bone and Joint Surgery
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Continuous monitoring of the performance of hip prostheses

S. L. Hardoon, MSc, Statistician1; J. D. Lewsey, PhD, Lecturer in Medical Statistics1; P. J. Gregg, MD, FRCS, FRCS(Ed), Professor of Orthopaedic Surgical Science2; B. C. Reeves, DPhil, Reader in Epidemiology3; and J. H. P. van der Meulen, PhD, MFPH, Director and Reader in Clinical Epidemiology1

1 Clinical Effectiveness Unit, The Royal College of Surgeons of England, 35-43 Lincoln’s Inn Fields, London WC2A 3PE, UK.
2 Orthopaedic Department, James Cook University Hospital, Middlesbrough TS4 3BW, UK.
3 Bristol Heart Institute, University of Bristol, Bristol Royal Infirmary, Marlborough Street, Bristol BS2 8HW, UK.

Correspondence should be sent to Dr J. D. Lewsey; e-mail: jlewsey{at}rcseng.ac.uk

New brands of joint prosthesis are released for general implantation with limited evidence of their long-term performance in patients. The CUSUM continuous monitoring method is a statistical testing procedure which could be used to provide prospective evaluation of brands as soon as implantation in patients begins and give early warning of poor performance. We describe the CUSUM and illustrate the potential value of this monitoring tool by applying it retrospectively to the 3M Capital Hip experience.

The results show that if the clinical data and methodology had been available, the CUSUM would have given an alert to the underperformance of this prosthesis almost four years before the issue of a Hazard Notice by the Medical Devices Agency. This indicates that the CUSUM can be a valuable tool in monitoring joint prostheses, subject to timely and complete collection of data. Regional or national joint registries provide an opportunity for future centralised, continuous monitoring of all hip and knee prostheses using these techniques.






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Registered charity no: 209299     Print ISSN: 0301-620X
Hip, Knee, Trauma, Upper limb, Foot & Ankle, Paediatrics, Oncology, Spine, Arthroplasty, General