The National Institute for Health and Clinical Excellence is examining percutaneous cementoplasty for palliative treatment of bony malignancies 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 percutaneous cementoplasty for palliative treatment of bony malignancies.

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The Advisory Committee will then prepare draft guidance which will be the basis for the Institute’s guidance on the use of the procedure in the NHS in England, Wales and Scotland.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: 28 March 2006

Target date for publication of guidance: June 2006

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

Current evidence on the safety and efficacy of percutaneous cementoplasty for the palliative treatment of bony malignancies is limited, but appears adequate to support the use of this procedure in patients for whom other treatments have failed, provided that the normal arrangements are in place for consent, audit and clinical governance.

Patient selection should be carried out in the context of a multidisciplinary team, which may include specialists in radiology, oncology, radiotherapy, orthopaedics, pain management and palliative care.

This procedure is indicated for patients with painful bone metastases resulting from tumours elsewhere in the body, or occasionally primary bone tumours. The procedure aims to reduce pain and also stabilise bones. Cementoplasty is the generic term for this procedure. Its use in vertebrae is commonly termed vertebroplasty (see section 3.1), and when treating the sacrum it may be described as sacroplasty.

Radiotherapy is commonly used to treat patients with painful bony malignancy, although the pain relieving effect can be delayed for up to 2 weeks. Conservative therapy includes analgesia (often with narcotic drugs) and bed rest. However, some patients remain refractory to both pharmacological and radiation treatment.

Percutaneous cementoplasty is the injection of acrylic bone cement into malignant bone cavities in order to relieve pain and/or stabilise the bone.

Percutaneous cementoplasty may be performed under general anaesthetic or, more commonly, by using conscious sedation and local anaesthesia. A small skin incision is made with a scalpel and under fluoroscopic guidance a 10−12-gauge trocar or needle is passed into the bone.

The cement is mixed with barium sulphate or another radiopaque agent. Visualisation of the cement during injection, via fluoroscopy (multi-plane), is essential to prevent extra-osseous leakage of cement. If leakage outside the bone occurs the injection is halted temporarily to allow the cement to harden and to plug the leak, or for the needle to be repositioned.

Once the procedure is completed, the patient should remain recumbent and should not weight bear while the cement hardens.

Pain scores (as measured by self reported visual analogue scale) were improved after cementoplasty in 14 patients in a case series from a mean 8.8 points at baseline to 1.9 points postoperatively (p < 0.0016). In another two studies good pain relief was achieved in between 82% (9/11) and 93% (13/14) of patients. In another case series 22% (4/18) of patients had ‘total improvement’ in pain (no pain without analgesics), while 39% (7/18) had clear improvement at 72 hours follow-up.

Two studies reported on mobility outcomes: one reported overall improvements in mobility in 93% (13/14) of patients at 1 week follow-up, and another study of 18 patients reported an improvement in mean walking score (on a 0 to 4 scale ) from 1.1 at baseline to 2.1 at 1 month follow-up.

The evaluation of technical success varied across the studies. In one case series cementoplasty was considered technically successful in 100% (14/14) of patients, and in another 39% (7/18) of patients demonstrated good filling on postoperative computed tomography scans. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors noted that the procedure was a variation on the existing technique of vertebroplasty but that its use for benign lesions was more novel.

Among four case series, leakage of injected cement was reported in 6% (1/18), 14% (2/14), 27% (3/11) and 50% (9/18) of patients. The definition of leakage (established either intra-operatively or postoperatively on imaging) varied between studies. Symptomatic cases relating to cement leaks were reported in between 6% (1/18) and 11% (2/18) of patients. One case report described an incident of sudden intra-articular cement leak which led to a covering of part of the femoral head. The patient suffered intense pain in the first 48 hours following the intervention and functional incapacity, and athroscopic ablation of the cement was done. Subsequent chondrolysis in 75% of the joint space required total hip replacement at 12 weeks.

Transient worsening of pain was recorded in 73% (8/11) of patients in one study. However, most patients experienced less pain at subsequent follow-up.

Other reported complications included fever (below 39°C) in 45% (5/11) of patients following the intervention and an increase in serum creatinine levels in 9% (1/11) of patients. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors noted that theoretical adverse events may include death from cement venous embolus, and nerve or vascular injury relating to local cement leak. Pathological fracture may occur. Infection, bleeding and thermal damage caused by the cement are additional concerns. One Specialist Advisor noted that heat from the cement might cause damage to neural structures.

It was noted that the procedure has also been used to treat benign bone lesions such as cysts, but very little data were available.

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

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

• Interventional procedures overviewofp ercutaneous cementoplasty for palliative treatment of bony malignancies, December 2005

  Available from: www.nice.org.uk/ip304overview