2 The procedure

2.1 Indications

2.1.1 Percutaneous vertebroplasty may be used to provide pain relief for people with severe painful osteoporosis with loss of height and/or compression fractures of the vertebral body, and also for people with symptomatic vertebral haemangioma and painful vertebral body tumours (metastases or myeloma).

2.1.2 Vertebral compression fractures are a common cause of pain and disability. Osteopenia, associated with ageing or chronic steroid use, and metastatic disease are the most common causes of vertebral compression fractures. Nearly all people experience pain. Most people are treated conservatively with analgesics, bed rest and bracing, but a small percentage are left with persistent pain and limited mobility.

2.2 Outline of the procedure

2.2.1 Percutaneous vertebroplasty is the injection of bone cement into the vertebral body to relieve pain, and to stabilise the fractured vertebrae.

2.3 Efficacy

2.3.1 The evidence reviewed indicated some level of pain relief in 58–97% of patients, with an associated reduction in medication usage in 50–91% of patients. One study indicated that 93% of patients had improved mobility and that 100% of patients were satisfied with the procedure and would have it again.

2.3.2 The opinions of the Specialist Advisors were divided about this procedure. Some believed that the procedure was proven to work, with numerous publications proving benefit. They believed that the procedure could have a major impact in the future as the incidence of osteoporotic spinal fractures increases in an ageing population. One Advisor suggested that it is effective in the majority of patients. Other Advisors suggested that the procedure is unnecessary, that the fractures will heal of their own accord, and that the procedure causes further fractures at a higher level of the spine.

2.4 Safety

2.4.1 Reported complications of this procedure were uncommon. They included damage to neural or other structures by needle misplacement or migration of cement. One study observed cement leakage in up to 27% of patients. However, this event was often without sequelae and required further intervention in only 1% of patients in that study.

2.4.2 The Specialist Advisors offered different estimates of risk but stated that the procedure carried a low risk in experienced hands. Some listed paraplegia as a risk (less than 5%), as well as the potential for nerve root damage and infection.

2.5 Other comments

2.5.1 The Medicines and Healthcare products Regulatory Agency (MHRA) has recently issued a safety notice on the use of cement in percutaneous vertebroplasty (MDA/2007/088).