NICE issues Guidance to the NHS on Artificial Hip Joints

Issued 31 March 2000 2000/0003a
NICE issues Guidance to the NHS on Artificial Hip Joints

NICE have today issued to the NHS their guidance on the Selection of Prostheses for Primary Total Hip Replacement. This press release should be read in conjunction with the full guidance document guidance. The guidance states that:

Using the most recent available evidence of clinical effectiveness, the best prostheses (using long term viability as the determinant) demonstrate a revision rate (the rate at which they need to be replaced) of 10% or less at 10 years. This should be regarded as the current 'benchmark' in the selection of prostheses for primary Total Hip Replacement (THR).
The Institute also considers it reasonable to recommend consideration of prostheses with a minimum of 3 years revision rate experience if their performance is consistent with the benchmark of a 10% revision rate at 10 years.
Prostheses (cemented, uncemented, and hybrid) that have not been shown to achieve either of these benchmarks should be the subject of comparative clinical evaluation before they can be recommended for routine use in the NHS.
There is currently more evidence of the long term viability of cemented prostheses, which, in many cases, occupy the lower end of the range of prostheses cost, than there is for uncemented and hybrid prosthesis.

Andrew Dillon, (Chief Executive of NICE) said, "This guidance is another step towards ending inequalities in health care for patients in England and Wales. Patients who are waiting to have a hip replacement can be assured that the decisions made by the Institute's appraisal committee were reached after careful consideration and it is expected that surgeons will take it fully into account when exercising their clinical judgement".

"I am pleased to announce that the NHS Purchasing and Supply Agency (working with the Welsh Health Supplies Organisation) has agreed to work with the Institute and the manufacturers of hip prostheses to collate and disseminate information about the performance of individual products against the 10 year full benchmark and the three year entry benchmark. This will avoid trusts having to collect this information individually. It is anticipated that the Agency will be in a position to supply information to trusts on benchmarked products from July 2000, at the latest, and that they will update their database on a regular basis."

Professor Sir Michael Rawlins (Chair of NICE) said, "Like other professionals, surgeons follow current best practice and always act in the interest of the patient. The guidance we have issued today means that no matter where you live, in England or Wales, surgeons and hospital teams will have access to the same information on what the NHS considers best practice in this area. We recommend that patients who are waiting for this operation, discuss our guidance with their surgeon to establish what effect, if any, it will have on their treatment."

ENDS

Notes for Editors
1. NICE was asked to look at the selection of prostheses for primary total hip replacement and provide guidance to the NHS which will help surgeons decide what type of prostheses to use. The guidance issued today is the result of that work.
2. Copies of the full guidance, information for patients and a summary of the evidence are available on the NICE web site (www.nice.org.uk).
3. A question answer document on this guidance is available on the NICE web site
4. NICE has provided a patient version of its guidance to the NHS, the full text is available on the NICE web site. In summary:
Wherever possible, the NHS should use artificial hip joints that can show they last for 10 years or more. This is called a benchmark.
Sometimes a surgeon might need to use an artificial hip that does not meet this benchmark. If this is the case, the hip should have at least 3 years evidence. This evidence should show that the artificial hip is on target to meet the 10-year benchmark.
Artificial hips that do not meet the standards 1 and 2 above should only be used in the NHS as part of a clinical trial. If you need one of these hips, then your surgeon will discuss the details of the clinical trial with you before you agree to have the operation.
Artificial hips are described in one of three ways: cemented, uncemented or hybrid. It depends on the design of the artificial hip and how it is fixed into the bone, during the operation.

There is more evidence that cemented artificial hips meet the 10-year benchmark (described in point 1) and produce the least pain and discomfort.

To help the NHS establish and do the best for their THR patients NICE has recommended that the NHS should set up a hip registry and should encourage more research.
5. The guidance recommends that the NHS encourage the establishment of a UK hip registry and further randomised controlled trials. The British Orthopaedic Association has established detailed guidelines on the establishment of such a hip register.
6. The guidance itself recommends that audit strategies are implemented at a local level to monitor the uptake of the NICE guidance and that the guidance should form part of local Clinical Governance arrangements. This will involve trust hospitals. The Commission for Health Improvement will review the implementation of this guidance.
7.
The NHS Purchasing and Supply Agency (working with the Welsh Health Supplies Organisation) has agreed with the Institute to work with hip prostheses manufacturers to collate and disseminate information about the performance of individual products against the 10 year full benchmark and the three year entry benchmark, in order to avoid trusts having to collect this information individually. It is anticipated that the Agency will be in a position to supply information to trusts on benchmarked products from July 2000, at the latest. They will update their database on a regular basis.
8. Each piece of NICE guidance has a review date - for hip prostheses the guidance will be reviewed in April 2003.
9. The full Guidance and patient notes are also available from

Tel: 0541 555 455
Fax: 01623 724 524
Post: PO Box 777 London SE1 6XH
Email: doh@prologistics.co.uk

10. The guidance represents the view of the Institute's Appraisal Committee, which was arrived at after careful consideration of the available evidence. Health professionals are expected to take it fully into account when exercising their clinical judgement about the circumstances in which it is appropriate to consider the removal of wisdom teeth. This guidance does not, however, override the individual responsibility of health professionals to make the appropriate decisions in the circumstances of the individual patient, in consultation with the patient and their guardian or carer
11. An appeal was heard in respect of this guidance on the 31 March 2000. The appeal was not upheld. The appellants were Cremascoli Fry Ortho Ltd and Zimmer Ltd ).

The guidance document provided to the appellants in preparation for their appeal is available on the web site

12. Artificial hip joints are also known as 'replacement hip joints' or 'hip prostheses'. They are inserted surgically into the hip to replace diseased or damaged joints. The operation is called a Total Hip Replacement (THR). THRs are often carried out to relieve discomfort and disability caused by joint disease (including osteoarthritis and rheumatoid arthritis of the hip). At present, THR is thought to be one of the most effective orthopaedic operations.

Approximately 35,000 THRs are carried out in the NHS in England and 2,800 in Wales each year. Between 10 to 15% of these have to be revised. Revised means that the operation has to be repeated. This could be because the replacement hip has worn out or because there was a problem following the operation.

There are more than 60 different artificial hips available for THR but they can be split into 3 groups: cemented, uncemented or hybrid. Which group an artificial hip is placed in depends on the way it is put in during the THR operation.

13. The National Institute for Clinical Excellence was set up as a Special Health Authority on the 1st April 1999 and as such it is a part of the National Health Service (NHS).
14 There are three main strands to the work of the Institute: appraisals of health technologies, the development of clinical guidelines and the promotion of clinical audit.
15 Responsibility for selecting the guideline topics referred to the Institute rests with the Secretary of State for Health and the National Assembly for Wales.