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Benefits and risks

Benefits and risks

When NICE looked at the evidence, it decided that there was enough evidence on the safety and efficacy of percutaneous insertion of craniocaudal expandable implants for vertebral compression fractures to allow it to be used. The 11 studies that NICE looked at involved a total of 1,243 patients.

Generally, they showed the following benefits:

  • a reduction in pain and improved function up to 12 months after the procedure

  • an increase in vertebral height in most patients and a straighter spine in some patients.

The studies showed that the risks of percutaneous insertion of craniocaudal expandable implants were similar to or less than with other surgery for vertebral compression fractures, and included:

  • leakage of bone cement into the surrounding tissue straight after the procedure in 3% to 55% of patients; in 1 patient this caused nerve pain

  • a tear in the thin layer covering the spinal cord, which was treated successfully

  • new spinal fractures in 8% to 21% of patients, which caused pain in some patients

  • urinary tract infection in 17% of patients

  • pain, skin infection, bruising, collapse of the bone, minor loss of vertebral height, neurological symptoms, movement of the implant and wrong insertion of the implant leading to damage of the spine , each in 1 patient.

NICE was also told about another possible risk: implant inserted in the wrong place so vertebral height was not restored.

If you want to know more about the studies, see the guidance. Ask your health professional to explain anything you don't understand.

  • Information Standard