Shoot from the hip

Dara Gantly, Editor, IMT

The recent hip-replacement recall shows just one element of the value of establishing national registries, says Dara Gantly

It is one thing to recall some children’s toys or even suspect batches of medicines that don’t meet quality standards, but quite another to recall artificial hips already implanted to 3,500 Irish patients.

Naturally enough, patients with hip replacements were extremely anxious when they saw the lead story on RTÉ News last Friday. Indeed, the speed at which the story broke would have only added to the concern.

On August 26, DePuy announced a worldwide recall of the ASR Hip System. The decision was based on new, unpublished data, which showed that the five-year revision rate for the ASR Articular Surface Replacement was approximately 12 per cent and for the ASR XL Acetabular System, it was about 13 per cent. The expected rate should be less than 1 per cent.

By the one o’clock news on August 27, the entire country knew of the recall, and of the potential impact for patients. But was all the anxiety justified?

Approximately 70,000 hip replacements have taken place in Ireland since July 2003, when this product first became available.

Approximately 5 per cent of these will be affected by this recall, as figures from the company indicate that 3,516 implants were sold in Ireland. And hopefully again, only a minority of these will ever experience any problems.

It is important to note that the unpublished data which brought the world’s attention to the problem came from National Joint Registry (NJR) of England and Wales — set up in 2002 to define, improve and maintain the quality of care of individuals receiving hip, knee and ankle joint replacement surgery across the NHS and the independent healthcare sector.

In April, the NJR issued an alert on all metal-on-metal (MoM) hip replacements (like the ASR system), and indeed back in 2008, the Australian National Joint Replacement Registry found that MoM had a “significantly higher” revision rate compared to the other three bearing surfaces — ceramic on polyethylene, ceramic on ceramic, metal on polyethylene — although it said this information should be “interpreted with considerable caution”.

But what was not in dispute at the time, or indeed now, is the benefit from having such a registry in place.

Irish orthopaedic surgeons have long wanted to establish both a national joint registry and a national registry for hip fractures – two areas in which new national comparative audits could be established.

What in fact may happen in the first instance is that Irish surgeons could link in with the National Hip Fracture Database (NHFD) in the UK. As a national audit project, the NHFD is intended to focus attention on hip fracture both locally and nationally, benchmark its care across the UK, and use continuous comparative data to create a drive for sustained improvements in clinical standards and cost effectiveness. Sounds like something for Dr Barry White and the new clinical leads, perhaps?

A similar drive towards establishing a national trauma registry is also under way, although like with so many things in Irish medicine, the scheme has been delayed due to a lack of funding. And yes, there is already a Trauma Audit & Research Network (TARN) in place in the UK, with which Irish doctors may well link in, to improve clinical standards in Ireland.

Other such registries could also be developed, which would not only spot potential problems like the ASR Hip System, and be able to notify all those affected instantly, but could play a critical role in the ongoing improvement of patient care.

You can accuse us of shooting from the hip if you like, but the roll out of national registries makes complete sense.