NICE updates guidance on autologous chondrocyte implantation use in treating cartilage defects in knee joints, UK

Main Category: Bones / Orthopedics
Article Date: 25 May 2005 - 10:00 PDT

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The National Institute for Health and Clinical Excellence (NICE) has today issued updated guidance to the NHS in England and Wales on the use of autologous chondrocyte implantation (ACI - formerly referred to as autologous cartilage transplantation or ACT) for treating cartilage defects in knee joints. NICE reviews each piece of guidance it issues and today's guidance replaces Technology Appraisal Guidance No. 16 issued in December 2000. In the review, NICE has recommended that:

-- ACI should not be used for the treatment of articular cartilage defects except where the treatment is part of a clinical study.

The current guidance makes it clear that every patient treated with ACI should be enrolled in a clinical study (including randomised trials), which should be designed to generate robust and relevant outcome data.

Andrea Sutcliffe, the Executive Lead for this appraisal said: "The evidence does not support the introduction of this technology into the NHS at this time, but we hope that by promoting its use in properly structured clinical studies, and with the results of ongoing research, we will have access to additional data to further inform the next review of the guidance."

The guidance acknowledges that there are further studies currently underway, and recommends that research is needed in a number of areas, including:

-- comparing different implantation treatments and other methods of mending damaged cartilage with conservative treatment such as intensive physiotherapy

-- the most appropriate way to measure how well the knee functions after surgical and non-surgical treatments, and relate this to a generic measure of health-related quality of life

-- the development of national registries, to enable the systematic collection of information on long-term outcomes for all patients treated with ACI.

For more information contact Dr Tonya Gillis on 020 7067 5937. Out of hours - 07775 583 813

About the NICE guidance on autologous chondrocyte implantation

1. A quick reference version of the new guidance is available on the NICE website at nice.org.uk/page.aspx?o=TA089quickrefguide The full guidance is also available on the NICE website at nice.org.uk/page.aspx?o=TA089guidance

2. The old NICE guidance on autologous cartilage transplantation, Technology Appraisal No.16 issued in December 2000, can be found at nice.org.uk/page.aspx?o=13463

3. 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.

4. 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.

5. Autologous cartilage implantation is a procedure during which normal cartilage cells are collected from inside the knee and grown in a laboratory for several weeks to increase the numbers of the cells. Once they have grown, the cells are implanted into the damaged area of the knee and sealed by a layer of tissue.

6. The Committee carefully considered new evidence from controlled trials that became available since the publication of the original guidance, but it was not convinced that the new data establish the effectiveness of the technology. The trials available provide inconsistent evidence of the clinical effectiveness of ACI. The relative effectiveness of ACI versus other treatments to mend damaged cartilage and also conservative therapy, remains unclear. In addition, the Committee concluded that health-related quality of life data on patients who undergo ACI and other procedures were inadequate.

About NICE

7. On 1 April 2005 the National Institute for Clinical Excellence took on the functions of the Health Development Agency to form the National Institute for Health and Clinical Excellence (NICE). NICE is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.

8. NICE produces guidance in three areas of health:

-- public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector

-- health technologies - guidance on the use of new and existing medicines, treatments and procedures within the NHS

-- clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

About technology appraisals

9. Technology appraisals are recommendations on the use of new and existing medicines and treatments within the NHS in England and Wales, such as:

-- medicines (for example, drugs)

-- medical devices (for example, hearing aids or inhalers)

-- diagnostic techniques (tests used to identify diseases)

-- surgical procedures (for example, repairing hernias)

-- health promotion activities (for example, patient education models for diabetes).

10. Our technology appraisal recommendations are prepared by an independent Committee, who include healthcare professionals working in the NHS and people who are familiar with the issues affecting patients and carers. The Committee considers the evidence on the clinical and cost effectiveness of the technology - this includes hearing the views of, and evidence from, clinical health professionals, experts and patients.

11. NHS organisations in England and Wales have to make the resources and facilities available to enable NICE guidance to be implemented. In January 2002 the Government announced a legal obligation for the NHS to provide funding for treatments and drugs recommended by NICE as a part of its technology appraisals work programme.

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