NICE, the health and social care guidance body, has published final guidance recommending two treatments for fractured bones in the spine (vertebrae) caused by osteoporosis.

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE, said: “We're pleased to recommend vertebroplasty and kyphoplasty, two treatments that can help to strengthen fractured bone and reduce pain. Osteoporotic vertebral compression fractures can have a major impact on quality of life, and can be painful and disabling. High doses of painkillers can also cause significant adverse effects, which can add to the distress and loss of self-esteem caused by the symptoms.”

The new guidance says that percutaneous vertebroplasty and percutaneous balloon kyphoplasty are recommended as options for treating osteoporotic vertebral compression fractures only in people:

• who have severe ongoing pain after a recent, unhealed vertebral fracture despite optimal pain management and
• in whom the pain has been confirmed to be at the level of the fracture by physical examination and imaging.

Vertebral compression fractures normally occur when the front of the vertebra collapses, and may be caused by trauma, cancer or osteoporosis. When this type of fracture is due to osteoporosis, it can cause the spine to become curved and can also cause loss of height. This may result in pain, difficulties in breathing, gastrointestinal problems and disturbed sleep. Vertebral fractures are more common in women, and the prevalence increases with age. As many of these fractures do not cause lasting symptoms, so are not identified, the prevalence of osteoporotic vertebral compression fractures is difficult to estimate. However, symptomatic fractures are associated with an increase in mortality, because of the impact on health from difficulties eating, breathing and moving about.

Vertebroplasty involves injecting bone cement into the solid part of the vertebra, to provide pain relief for people with painful fractures and to strengthen the bone to prevent future fractures. Kyphoplasty without stenting is a variation of vertebroplasty involving inserting a balloon-like device into the solid part of the vertebra and slowly inflating it until it restores the normal height of the bone. When the balloon is deflated, the space is filled with bone cement. Kyphoplasty aims to reduce curvature of the spine.

Professor Longson continued: “NICE has previously published interventional procedures guidance which set out that vertebroplasty and kyphoplasty were safe enough to be considered for use in the NHS. This new technology appraisal guidance highlights that as these procedures provide benefits to patients and value for money, they ought to be offered to patients when appropriate.”

Ends

Notes to Editors

About the guidance

1. The guidance ‘Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures´ is available from 24 April 2013. Please contact the NICE Press Office for embargoed copies.

2. The Committee concluded that the incremental cost effectiveness ratios (ICERs) established for both kyphoplasty and vertebroplasty were generally at the lower end of what is usually considered to be cost effective.

3. Several bone cements are available for vertebroplasty. The acquisition cost of the high-viscosity Confidence Spinal Cement System (Johnson and Johnson) is based on the number of vertebrae being treated. The average cost of the kit is £1472. Low-viscosity cements are available and, based on list prices provided by 2 manufacturers (Cook and Stryker), the Assessment Group estimated a cost of £800 per low-viscosity cement vertebroplasty procedure.

4. The Kyphon BKP kit (Medtronic) is available in the UK for kyphoplasty. Kyphon BKP is a CE-marked, single-use sterile pack with a list price of £2600.50 and includes 2 Kyphon Xpander inflatable bone tamps (balloons) and Kyphon ActivOs bone cement with hydroxyapatite.

5. Adverse reactions from vertebroplasty and kyphoplasty related primarily to cement leakage, particularly for vertebroplasty. The Committee heard that leakage could be intradiscal or intravascular, with intravascular leaks increasing the risk of cement pulmonary embolism. The Committee concluded that cement leakage associated with vertebroplasty and kyphoplasty was manageable if a skilled clinician with specialised training in these procedures performs the operation.

6. NICE has already recommended a range of drug treatments to help prevent primary and secondary osteoporotic fractures: Osteoporosis - primary prevention (TA160), Osteoporosis - secondary prevention including strontium ranelate (TA161) and Osteoporotic fractures - denosumab (TA204).

The interventional procedures guidance on using percutaneous vertebroplasty and balloon kyphoplasty for vertebral compression fractures is available on the NICE website.

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012).

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

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