Press release on ACT for defects in knee joints

The National Institute for Clinical Excellence (NICE) has today (20 December 2000) issued its guidance to the NHS on the use of autologous cartilage transplantation for defects on knee joints. NICE has recommended that:

• Autologous Cartilage Transplantation (ACT) should not currently be used for routine primary treatment of articular cartilage defects of the knee joint.

• ACT should only be performed as part of a properly structured clinical trial.

• ACT treatment may be undertaken, by exception, in centres participating in clinical trials of this procedure when other treatments for articular cartilage defects of the knee joint have already failed.

Andrew Dillon, the Institute's Chief Executive said: "Although the evidence does not support the widespread introduction of this technology into the NHS at this time, by promoting its use in properly structured clinical trials we will have access to additional data to support our review of the guidance in 2003."

Ends

Notes for Editors

1. Cartilage provides a smooth surface at the ends of bones that makes the movement within the knee joint easier and acts as a shock absorber to cushion the bone from forces of more than five times the body's weight. Cartilage lacks blood and nerve supplies, and therefore has a limited ability to repair itself.

2. Cartilage damage can be caused directly from injury, for example from sports, or suddenly for no apparent reason. People who damage their cartilage often experience knee pain, knee swelling, joint locking (this is when a joint becomes stuck in one position) and the 'giving way' of the joint.

3. Autologous cartilage transplantation is a procedure during which normal cartilage cells are collected from inside the knee and sent to a laboratory to grow for several weeks. Once they have grown, the knee is operated on and the cells are placed into knee and sealed by a layer of tissue from the leg bone (tibia). This second operation requires a hospital stay of a day or two and following the operation the patient must have extensive rehabilitation treatment (including physiotherapy) and athletic activities & strenuous work are not permitted for between six months and a year.

4. Estimates on the number of potential ACT operations in England and Wales range from 300 to 850 per year.

5. There is no uniform approach to managing hyaline cartilage defects in knees. The most common treatment options include a knee washout and debridement (trimming the loose tissue flaps), 'marrow stimulation techniques', various tissue grafts from outside the joint (for example rib or periosteum grafts), and grafts of normal cartilage cores from within an affected joint (mosaicplasty).

6. There are no completed randomised clinical trials comparing outcomes with the alternative treatment modalities. Several randomised trials are currently under way, but it will be some time before these come to conclusion.

7. Estimates of the cost of ACT, including cell culturing and surgery, are £3,200, £4,700 and £8,600, depending on which service provider is used for culturing the cells.

8. If 850 patients per year were to be offered ACT treatment as second-line therapy, following failure of other therapies, at a cost of between £4,200-£8,100, the additional cost to NHS would range from £3.6m to £6.9m per annum.

9. Given the lack of comparative evidence on clinical effectiveness, it is not meaningful to make any estimate of cost-effectiveness.

General Information

10. Copies of the full guidance and supporting documentation will be available on the NICE web site (www.nice.org.uk) from 12pm (lunchtime) on Wednesday 20th December.

11. Health professionals are expected to take the Institute's guidance fully into account when exercising their clinical judgement for individual patients. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

12. The National Institute for Clinical Excellence (NICE) is a part of the NHS. Part of its work is technology appraisals. That is we use a team of experts to produce guidance for both the NHS and patients on medicines, medical equipment and clinical procedures based on evidence of clinical and cost effectiveness. Each appraisal takes around 12 months to complete and involves the manufacturers of the technology, patient groups and professional organisations.

13. NICE promotes clinical and cost effectiveness through its technology appraisals, clinical guidelines and audit tools. NICE supports the work of those who make the complex treatment decisions - doctors, nurses, and other health professionals. The needs of the patient are central to NICE's work, and the Institute has forged strong links with patient groups and representatives.

14. NICE appraises new and existing health technologies, as selected by the Department of Health and the National Assembly for Wales and advises the NHS on how these technologies can best be used. It is also responsible for the production of national clinical guidelines, promoting best practice throughout the NHS. To support and assess the implementation of such guidelines, NICE will produce audit tools for use in the clinical setting.