Addressing the opioid crisis
With minimally invasive treatment options for patients with VCFs
Medtronic Interventional Pain has been relieving vertebral compression fracture (VCF) pain since 1998 and will continue to invest in the clinical and economic evidence to back vertebral augmentation approaches.
Through our promise to invest in powerful evidence, we sponsored a 7-month retrospective study (Ni, et al.)1 that presented results on Balloon Kyphoplasty (BKP) and Vertebroplasty (VP):
- 48.7% of patients discontinued the use of oral opioids
- An additional 8.4% lowered their dosage, compared to pre-surgery levels
- A significant decrease in all-cause post-surgical costs
The study, “Trends in opioid use following balloon kyphoplasty or vertebroplasty for the treatment of vertebral compression fractures,” was published in Osteoporosis International. A 7-month retrospective analysis compared opioid use and hospital visits in 8,845 patients before and after a BKP/VP procedure.
- 75.3% of patients underwent BKP and 24.7% underwent VP, with a mean age of 77.
- Among the 75% who filled an opioid prescription at baseline, 48.7% of patients discontinued opioid medication and 8.4% reduced their average daily dosage within 7 months follow-up versus preoperative baseline.
- Total payer costs significantly decreased over 7 months follow-up relative to baseline among patients who decreased or discontinued opioid use (-$6,759); while total costs increased (+$160) among those whose dosage remained the same, increased, or newly started.
More than 800,000 VCFs occur each year in the United States due to osteoporosis. These injuries can cause severe pain, limited mobility, and reduced quality of life. VCFs traditionally were treated with nonsurgical management including bed rest, bracing, and pain medications. Over the years, however, studies comparing balloon kyphoplasty to non-surgical management have shown balloon kyphoplasty produced better pain relief and quality of life for patients with acute VCF compared to patients treated with non-surgical management.2-4
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Medtronic’s KyphonTM balloon kyphoplasty is a minimally invasive surgical procedure for the treatment of spinal fractures due to osteoporosis, cancer, or non-cancerous tumors. Balloon kyphoplasty relieves pain from vertebral compression fractures by using orthopaedic balloons to restore vertebral height and correct angular deformity.2 After reduction, the balloons are deflated and removed. The resulting cavity allows for a controlled deposition of Kyphon bone cement, which helps form an internal cast and stabilize the fracture. The procedure typically takes about an hour and can be done on an inpatient or outpatient basis.
Although the complication rate for KyphonTM balloon kyphoplasty is low, as with most surgical procedures, serious adverse events, some of which can be fatal, can occur, including heart attack, cardiac arrest (heart stops beating), stroke, and embolism (blood, fat or cement that migrates to the lungs or heart). Patient results may vary. This procedure is not for everyone. A prescription is required.
Medtronic Interventional Pain will continue to collect data that further supports the benefits of minimally invasive surgical treatments that provide choices beyond opioids usage, such as BKP/VP. Our dedication to clinical research is inspired by our commitment to the advancement of pain therapy and the restoration of patient health.
To learn more about vertebral augmentation, visit medtronic.com/VAEvidence.
REFERENCES
- Ni W, Ricker C, Quinn M, Gasquet N, Janardhanan D, Gilligan CJ, Hirsch JA. Trends in opioid use following balloon kyphoplasty or vertebroplasty for the treatment of vertebral compression fractures. Osteoporos Int. 2021 Nov 2. doi: 10.1007/s00198-021- 06163-3. Epub ahead of print. PMID: 34729624.
- Berenson J, Pflugmacher R, Jarzem P, et al. Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial. Lancet Oncol. 2011 Mar;12(3):225-35.
- Boonen S, Van Meirhaeghe J, Bastian L, et al. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. J Bone Miner Res. 2011;26(7):1627-1637.
- Van Meirhaeghe J, Bastian L, Boonen S, et al. A randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures: vertebral body kyphosis correction and surgical parameters. Spine. 2013;38(12),971-983.
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