Multi-Center Data in a Large Series of Patients Show Vertebroplasty Provides Dramatic and Lasting Pain Relief for Vertebral Compression Fractures

CAGLIARI, Italy, Feb. 17 /PRNewswire/ -- The results of a study of more than 4500 patients from six Italian EVEREST (European Vertebroplasty Research Team) Centers (Dr. G.C. Anselmetti-Candiolo Torino, Dr. G. Bonaldi-Bergamo, Dr. P. Carpeggiani-Pisa, Dr. S. Masala-Roma, Dr. M. Muto-Napoli,) confirms the effectiveness of vertebroplasty in treating vertebral compression fractures (VCFs), finding that the procedure provides significant and sustained pain relief.

Patients had immediate relief of back pain and were able to discontinue taking analgesics immediately following the procedure.

Vertebroplasty is an outpatient procedure performed under local anesthesia and involves injecting bone cement into the collapsed vertebral body. Minimally invasive, the procedure stabilizes the fracture and stops the pain caused by bone rubbing against bone. It is indicated for painful VCFs that fail to respond to conventional medical therapy, such as minimal or no pain relief with medication or narcotic doses that are intolerable.

"In our large series of patients, vertebroplasty proved to be a safe and effective treatment, resulting in same day, dramatic improvement in pain," said Stefano Marcia, M.D., interventional radiologist at San Giovanni di Dio Hospital in Cagliari, Italy.

Dr. Marcia will be presenting his team's results at the American Society of Spine Radiology's 2010 Annual Symposium this week in Las Vegas, during a seminar sponsored by Stryker Interventional Spine. The event is scheduled for February 19, 2010 at 2:30 pm.

Materials and Methods

In the study, Dr. Marcia and his colleagues retrospectively evaluated the clinical outcomes of vertebroplasty in 3211 women and 1336 men treated in six different EVEREST centers.

The patients were affected by severe painful osteoporosis, painful vertebral tumors (metastases or myeloma) with high risk of fracture and symptomatic vertebral angioma.  Inclusion criteria were VCF with bone edema on MRI, local back pain with single-point pressure on examination, and poor or no response to medical therapy.

The average number of VCFs treated with vertebroplasty in the same patient was three, for a total of 13,437 fractures.

Patients were evaluated at baseline and through a one-year follow-up for pain relief using an 11-point visual analog scale (VAS) with zero as no pain and 10 as the most severe pain. Evaluation at each follow-up point included pain response using VAS, physical examination and x-ray at 48 hours and one month, and physical examination at three months and one year.

Results

Within 48 hours, 4004 of the 4547 patients (88.06 percent) experienced clinically significant pain relief, with an average VAS score of 2 and an average difference from baseline of 5.5 to 6. The mean difference in VAS scores was P < .0001. The pain remained improved at each follow-up evaluation up to 12 months.

In osteoporotic patients, the average pre-treatment pain score on the VAS was 7.7 +/- 0.4, which dropped substantially to an average of 1.8 +/- 0.6 after vertebroplasty.

In patients with metastases, the VAS score was 8.3 +/- 0.4 before vertebroplasty and 2.4 +/- 0.4 after vertebroplasty.

For myeloma patients, the pre-vertebroplasty pain score was 8.3 +/- 0.4 and the post-vertebroplasty pain score was 1.7 +/- 1.0.

For hemangioma the VAS scores were 6.2 +/- 3.5 before the treatment and 0.3 +/- 0.2 after the treatment.

Trauma patients reported an average pre-vertebroplasty VAS score of 7.4 +/- 0.4 and a post-vertebroplasty VAS score of 1.4 +/- 0.9.

No major neurologic complications were encountered. Venous leakage was the most frequent mild one (20.5 percent).

The data add to the growing body of evidence that demonstrates vertebroplasty is a safe and effective treatment with a low complication rate. Vertebroplasty is widely available in the United States and is covered by Medicare and most private insurers.

"Evidence and experience related to the use of vertebroplasty have been overwhelmingly positive with the sole exception of the studies by Buchbinder et al, and Kallmes et al published recently in The New England Journal of Medicine," said Dr. Marcia. "We believe that our EVEREST study ascertains the efficacy of the procedure and is good news for patients who are in terrible pain caused by vertebral compression fractures."  

Dr. Marcia added that the study also demonstrates that vertebroplasty does not increase the risk of fracture in nearby vertebra. Of the 4547 patients treated, only 430 (13 percent) were retreated for a subsequent fracture. In 302 of those 430 patients (70.2 percent), the new fracture occurred in the contiguous vertebra.

"Vertebroplasty is shown to provide sustained pain relief for osteoporotic vertebral fractures. Osteoporosis, metastases and myeloma patients remain susceptible to new fractures, which often occur in the vertebra next to an existing fracture. Our large-scale study shows that vertebroplasty does not increase the risk of fracture in the level adjacent to previously treated vertebra and that these new fractures occur at the same rate as they would in patients who did not have vertebroplasty," explained Dr. Marcia.

The abstract of  "Percutaneous Vertebroplasty: Results and Complications in 4547 Patients Treated in Six Italian EVEREST (European Vertebroplasty Research Team) Centers" can be found online by searching "CIRSE Abstract Book 2009."

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