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Figure 6: Reduced Activity (Days)
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Figure 7: % of Patient Requiring Opioids
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Outcomes according to the clinical trial:

Restricted Activity

Balloon kyphoplasty patients had significantly fewer reported days of restricted activity than non-surgical patients in the year-long period (see Figure 6). These days were defined as restricted activity days or bed rest (>1/2 the day in bed) because of back pain in the previous 14 days. Lower scores are better, indicating fewer restricted days.

  • At 1 month, the kyphoplasty group reported significantly fewer days of restricted activity (2.9 fewer days of restricted activity per 2 weeks than the non-surgical group). The difference at 12 months was still 1.6 days fewer days, but that difference was no longer statistically significant.
  • On average, the balloon kyphoplasty group experienced 2.5 fewer days of restricted activity per every two weeks of treatment. Throughout the 12 months, patients in the balloon kyphoplasty group had an average of 60 fewer days of restricted activity.
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Pain Medications

The balloon kyphoplasty patients required significantly fewer narcotic (opioid) pain medications than the control group, especially between 1 month and 6 months. At 1 year, the percentage of patients requiring opioids was still fewer in the balloon kyphoplasty group (dropped from greater than 70% to less than 30% of the narcotic pain medication use) but the difference was much less significant because of further improvement in the control group over time (see Figure 7).

Adverse Events and Risks of Balloon Kyphoplasty

There was no difference in the overall frequency of adverse events between the kyphoplasty and control (nonsurgical care) groups, with about 1/3 of patients in each group experiencing some sort of adverse event. Serious adverse events are defined as death, life threatening injury, permanent impairment, or if an extended hospital stay was required to prevent permanent injury. There were no deaths related to the balloon kyphoplasty procedure or device.

In the balloon kyphoplasty group, there were two serious adverse events related to the kyphoplasty procedure itself: a soft tissue hematoma (a collection of blood within a body tissue or cavity due to a ruptured blood vessel) at the surgical site and urinary tract infection that needed treatment. Other serious adverse events occurred during the trial timeframe but were not related to the kyphoplasty procedure.

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For 27% of the fractured vertebrae that were treated with kyphoplasty, some cement extruded from the fracture area during the procedure, but all cases were asymptomatic (did not cause symptoms) during the 12 month evaluation period.

The possible increased risk of subsequent fractures after balloon kyphoplasty is unclear from the results of this study. While the numerical rate of additional fractures over time was higher in the kyphoplasty group (33% vs. 25% in the control group at 12 months), the difference was not statistically significant.

Overall, the FREE study found that Kyphon Balloon Kyphoplasty is a safe and beneficial treatment for vertebral compression fractures when compared to non-surgical treatment. This was previously demonstrated in two smaller, controlled (but not randomized) studies comparing balloon kyphoplasty with non-surgical care one reporting 6 month results and the other reporting 12 month and 36 month results.

  1. Komp M., et al., Minimially Invasive Therapy for Functionally Unstable Osteoporotic Vertebral Fracture By Means of Kyphoplasty: Prospective Comparative Study of 19 Surgically and 17 Conservatively Treated Patients. J Miner Stoffwechs 2004; 11 (Suppl 1):13-15.
  2. Grafe IA, De Fonseca K, Hillmeier J, et al. Reduction of pain and fractures after kyphoplasty: One-year outcomes of a prospective controlled trial of patients with primary osteoporosis. Osteoporosis Internat 2005: 16:2005-2012.
  3. Kasperk C, et al. Three-year outcomes after kyphoplasty in patients with osteoporosis with painful vertebral fractures. J Vasc Interv Radiol. 2010; 21(5):701-9.