Interventional procedures consultation document - balloon kyphoplasty for vertebral compression fractures

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Balloon kyphoplasty for vertebral compression fractures

The National Institute for Health and Clinical Excellence is examining balloon kyphoplasty for vertebral compression fractures and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about balloon kyphoplasty for vertebral compression fractures.
This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

comments on the preliminary recommendations
the identification of factual inaccuracies
additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual).

Closing date for comments: 31 January 2006
Target date for publication of guidance: April 2006

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

1	Provisional recommendations

1.1	Current evidence on the safety and efficacy of balloon kyphoplasty for vertebral compression fractures appears adequate to support the use of this procedure provided that normal arrangements are in place for consent, audit and clinical governance.

1.2	The following are recommended. This procedure should only be undertaken with prior discussion by a specialist multidisciplinary team that includes a radiologist and a spinal surgeon, and when there are facilities for good imaging, and arrangements for good access to a spinal surgery service. Clinicians should receive training to reach an appropriate level of expertise before carrying out this procedure. In particular, they must follow the manufacturer's instructions for making the cement, to reduce the risk of embolisation. The procedure should be limited to patients whose pain is refractory to more conservative treatment.

2	The procedure

*2.1*	*Indications*

2.1.1	Vertebral compression fractures are one of the most common types of osteoporotic fracture. Osteoporotic fractures are common in the elderly and particularly in post-menopausal women, but can also be associated with other factors such as chronic steroid usage. Other causes of vertebral compression fracture include malignancy in the vertebrae or more rarely haemangioma.
2.1.2	Pain is the most common symptom in patients with vertebral compression fractures. Fractures can also cause progressive spinal deformity with abnormal curvature (kyphosis). This can lead to increased risk of further fracture at adjacent levels and progressive malalignment, deformity and pain. There is also an increased risk of falls.
2.1.3	Conventional treatment for vertebral compression fractures is focused on the alleviation of symptoms with analgesic medication and spinal support. The majority of patients become symptom free through these measures and surgery is rarely indicated.
2.1.4	Surgery may be considered in patients whose condition is refractory to medical therapy and in whom there is continued vertebral collapse and severe pain. Recently there has been increased interest in minimally invasive procedures including kyphoplasty and vertebroplasty.


*2.2*	*Outline of the procedure*

2.2.1	Balloon kyphoplasty is performed under local or general anaesthesia assisted by fluoroscopy. One or more levels of the spine can be treated in one session.
2.2.2	The fractured vertebra is accessed through a small incision in the patient's back. A hand-drill is used to create a channel through which a balloon-like device (inflatable bone tamp) can be inserted into the medullar space. The inflatable tamp is positioned in the vertebral body and filled with a radiopaque contrast medium for visualisation. The balloon is slowly inflated until the normal height of the vertebral body is restored or the balloon reaches its maximum volume. The balloon is then deflated and the cavity created filled with cement (typically polymethylmethacrylate, PMMA) at a low pressure.


*2.3*	*Efficacy*

2.3.1	Three non-randomised studies were reviewed: two comparing balloon kyphoplasty to conventional medical care (physical and analgesic therapy) and one comparing the procedure to vertebroplasty. All three studies found that patients who had undergone balloon kyphoplasty had improved pain scores compared to the control group at a maximum follow-up of 24 months.
2.3.2	In two non-randomised controlled studies, physical function following balloon kyphoplasty, as measured by the European Vertebral Osteoporosis Study Group questionnaire or Oswestry Disability Index (ODI), was shown to be significantly improved from baseline at 12 months. However in one of these trials physical function (ODI) at 2 years was not found to be significantly different from preoperative values in either the balloon kyphoplasty (61% vs 56%) or the vertebroplasty group (61% vs 52%).
2.3.3	In a study of 222 patients (360 procedures), a greater than 20% restoration of lost vertebral height was achieved in 63% and 69% of fractures at the anterior and midline respectively, and the kyphosis angle decreased from 22° to 15°. In a study comparing kyphoplasty with conventional medical care, midline vertebral body height was significantly increased in the kyphoplasty group compared with that at baseline and at 12 months was significantly greater than in the controls (67% vs 56%). For more details refer to the sources of evidence (see Appendix).

2.3.4	The Specialist Advisors expressed uncertainties about whether the improvements following kyphoplasty (reduced pain and height restoration) are maintained in the long term.


*2.4*	*Safety*

2.4.1	The most commonly reported complications following balloon kyphoplasty were cement leaks and new fractures. One study of 360 procedures in 222 patients reported 38 cement leaks (11% of procedures), with one resulting in an episode of radiculopathy (the patient recovered with selective nerve block and rehabilitation). In another study of 192 procedures in 102 patients cement leaks were reported from eight vertebral bodies (7%), all of which were asymptomatic.

2.4.2	In one study of 115 osteoporotic patients (225 procedures), 26 patients (23%) developed a post-procedure fracture. In the non-randomised controlled study comparing balloon kyphoplasty to standard medical care, seven new fractures were observed in 7/40 (18%) of patients in the balloon kyphoplasty group, compared to 11 fractures in 10/20 (50%) of patients in the control group.
2.4.3	Other reported adverse events during or after balloon kyphoplasty included balloon rupture (two cases), motor deficits due to faulty puncture (one case) and epidural bleeding (one case).
2.4.4	In a review of complications reported to the Food and Drug Administration Medical Device website, there were 33 major complications in patients (denominator estimated at between 40,000 and 60,000 procedures) following balloon kyphoplasty. These included one death, five cases of permanent paralysis, radiculopathy, paraesthesia or loss of motor function, and 13 cases of canal intrusion or cord compression. For more details refer to the sources of evidence (see Appendix).
2.4.5	The Specialist Advisors listed cement leakage as the most common complication following balloon kyphoplasty. They also listed infection, allergy and spinal cord or nerve root injury due to incorrect needle placement as potential complications.

2.5	Other comments
2.5.1	The Medicines and Healthcare products Regulatory Agency (MHRA) has issued two safety notices on the use of cement in balloon kyphoplasty (MDA/2003/021, MDA/2004/027). See www.devices.mhra.gov.uk

3	Further information

3.1	The Institute has published guidance on percutaneous vertebroplasty (www.nice.org.uk/IPG012).

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
January 2006

Appendix:

Sources of evidence

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

Interventional procedure overview of balloon kyphoplasty for vertebral compression fractures, June 2005

Available from: www.nice.org.uk/ip179overview

This page was last updated: 30 January 2011