Results & Complications

Focus on Complications

These Complications are from Food and Drug Administration (FDA) Center (http://www.fda.gov/cdrh/maude.html) about patients treated in the USA from 1999 to 2003:

            VERTEBROPLASTY 

(175.000 patients from 1999 to 2003)

Small venous embolization (generally asymptomatic) of the cement (around 40%) 

Small Cement leaks in the perivertebral soft tissue itwh residual fibrosis (1 case out of 10.000) resolved with steroid loco- regional infiltration

Needle rupture (6 cases out of 175.000; always asymptomatic) 

Allergic reaction to bone cement with blood pressure drop (2 cases out of175.000) 

Large Lung embolism with Acute respiratory failure (1 case out of 175.000) 

Leakage of Cement in the spinal space (requiring immediate surgical decompression) leading to paraplegia (1 case out of 175.000) 

Death (7 cases out of 175.000) 

             KYPHOPLASTY 

(50.000 patients from 1999 to 2003)

Endovertebral rupture of the system (asymptomatic) (6 cases out of 50.000) 

Hypotension (1 case out of  50.000) 

Pneumotorax (1 case out of  50.000) 

Infection with discitis or osteomyelitis (2 cases out of  50.000) 

Ileo (1 case out of 50.000) 

Large Lung Embolism resolved with medical therapy (1 case out of 50.000) 

Leakage of Cement in the spinal space requiring immediate surgical decompression (14 cases out of 50.000) 

Leakage of Cement in the spinal space requiring immediate surgical decompression or Spinal cord direct lesion (leading to paraplegia) (6 cases out of 50.000) 

Death (1 case out of 50.000)

                   RESULTS

Vertebroplasty can achieve a complete pain resolution or a significative pain reduction from 90% to 95% rate of all osteoporotic patients and 70% to 85% in the malignancy with a very low rate (<1%) of severe complications. Complications may occurr if the procedure is perfomed by a not trained physician or low quality radiologic guiding system is employed.

These procedures are aimed to cure only the pain but are not able to cure the disease that causes the pain (i.e. vertebroplasty do not cure the osteoporosis or the breast cancer) so an integration with coventional medical theraphy is often required.

Even if a correct medical therapy for osteoporosis is given, 9% to 15% of treated patients reported a new fracture in other vertebra. This can occur between 7 days to 3 years from the first treatment; these new fracture can be easily and successfully treated again with Vertebroplasty.

             COMPLICATIONS

MINOR: 

Venous lumbar plex embolization (asymptomatic)

Small Cement leaks in the perivertebral soft tissue (asymptomatic)

Foramina perineuritis (generally asymptomatic or easily resolved with steroid loco- regional infiltration) 

Small Lung embolism (generally asymptomatic)

SEVERE: 

Leakage of Cement in the spinal space (rare complication requiring immediate surgical decompression)

Spinal cord direct lesion (leading to paraplegia)

Large Lung embolism with Acute respiratory failure

Death

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