The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on Percutaneous vertebroplasty in September 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 the NICE guideline CG75 on metastatic spinal cord compression: Diagnosis and management of adults at risk of and with metastatic spinal cord compression.The interventional procedure guidance on percutaneous vertebroplasty remains current, and should be read in conjunction with the clinical guideline.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued safety notices relating to this procedure (Reference No. MDA/2003/021).
Percutaneous vertebroplasty is a treatment for vertebral compression fractures, which are a common cause of pain and disability. Each year over 270,000 painful vertebral fractures are clinically diagnosed in the USA, and numbers are increasing. Osteopenia associated with aging or chronic steroid use and metastatic disease are the most common aetiologies of vertebral compression fractures. All patients experience pain, which can be of varied duration. Most patients are treated conservatively with analgesics, bedrest and bracing, but a small percentage is left with persistent pain and limited mobility.
Percutaneous vertebroplasty may be used to provide pain relief for patients with severe painful osteoporosis with loss of height and/or with compression fractures of the vertebral body and also for patients with symptomatic vertebral haemangioma and painful vertebral body tumours (metastasis and myeloma).
Percutaneous vertebroplasty involves the injection of acrylic bone cement into the vertebral body in order to relieve pain and/or stabilise the fractured vertebrae and in some cases, restore vertebral height.
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.