The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on Balloon kyphoplasty for vertebral compression fractures in April 2006.
It replaces previous guidance on balloon kyphoplasty for vertebral compression fractures (Interventional Procedures Guidance no. 20, November 2003).
Further recommendations have been made as part of the clinical guideline on metastatic spinal cord compression published in November 2008, as follows:
Vertebroplasty or kyphoplasty should be considered for patients who have vertebral metastases and no evidence of MSCC or spinal instability if they have either:
- mechanical pain resistant to analgesia, or
- vertebral body collapse.
Vertebroplasty or kyphoplasty for spinal metastases should only be performed after agreement between appropriate specialists including an oncologist, interventional radiologist, and spinal surgeon, and in facilities where there is good access to spinal surgery.
Clinical and cost-effectiveness evidence was reviewed in the development of this guideline which has led to this more specific recommendation. More information is available from NICE guideline CG75. The IP guidance on Balloon kyphoplasty for vertebral compression fractures remains current, and should be read in conjunction with the clinical guideline.
Balloon kyphoplasty is performed by inserting a balloon-like device (inflatable bone tamp) through a channel created by a hand drill in the fractured vertebrae. The tamp is positioned and inserted into the vertebral body. The ballon is then inflated slowly until normal height of the vertebral body is restored or the balloon reaches its maximum volume.
The procedure is intended to restore vertebral height and correct kyphosis. It may also help to improve pulmonary and gastrointestinal function and reduce the likelihood of subsequent vertebral compression fractures.
The inflation of the balloon tamp creates a cavity in the vertebral body so that when the bone tamp is withdrawn, cement can be injected into the cavity at a lower pressure, potentially reducing the risk of cement leakage. The cement increases the strength of the vertebra and is intended to provide pain relief.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.