Based on the 1-year findings of the FREE study, Kyphon Balloon Kyphoplasty produced significantly better outcomes for acute vertebral compression fractures at one month after treatment than non-surgical care.
On average, patients receiving balloon kyphoplasty sustained greater benefits than non-surgical care during the 12 months after treatment, although some differences in improvement were diminished over time, possibly as a result of the compression fractures eventually healing and pain diminishing even without any surgical procedure.
The study findings suggested the following:
- The patients treated with balloon kyphoplasty had significantly better outcomes in terms of pain reduction, quality of life, function and mobility both initially, at one month, and throughout 12 months compared to non-surgical care.
- These study findings suggest that balloon kyphoplasty may be considered earlier in the course of spinal fracture treatment to provide faster relief of pain and improved function.
- The study confirmed results of earlier studies that balloon kyphoplasty is a relatively safe and effective method of treating painful vertebral compression fractures as compared to nonsurgical treatment.
In This Article:
- Balloon Kyphoplasty: Clinical Evidence for Treating Spinal Fractures
- Vertebral Compression Fracture Treatment Review
- Fracture Reduction Evaluation (FREE) Clinical Trial Methodology
- Results of the FREE Study on Kyphon Balloon Kyphoplasty
- Clinical Trial Outcomes: Back Pain, Quality of Life, Disability
- Clinical Trial Outcomes: Restricted Activity, Pain Medications, Adverse Effects
- Limitations of the FREE Study
- Kyphoplasty (Osteoporosis Fracture Treatment) Video
Potential implications of the study findings:
- Patients with recent spine fractures (and other characteristics similar to those of patients in the FREE study) who choose balloon kyphoplasty can expect more pain reduction, quality of life, function and mobility on average over the course of the 12 months following the procedure than if they had chosen non-surgical treatment for their spine fracture.
- Patient who would rather avoid surgical treatment and choose non-surgical treatment for their spine fracture can expect to experience on average more pain and reduced function over the course of the 12 months of treatment than if they had chosen balloon kyphoplasty.
- Doctors may prescribe balloon kyphoplasty for acute vertebral compression fractures earlier in the typical treatment cycle.
- Patients may request balloon kyphoplasty earlier in an effort to experience pain relief and improved function sooner.
- Whether a patient is treated with balloon kyphoplasty or non-surgical care, either course of treatment is relatively safe as compared to the other and few adverse events are expected with balloon kyphoplasty.
Clinical outcomes in specific areas: