Our priority has always been to raise awareness of available treatments for vertebral compression fractures (VCF) and to refine our innovative technology in partnership with physicians and patients.
VCFs are associated with a downward spiral of complications, including decreased mobility, pain, and function.1-3 Clinical evidence has shown that balloon kyphoplasty (BKP) has offered important clinical benefits, including pain relief, reduced opioid use, and improved quality of life.4-9
Kyphon™ balloon kyphoplasty is celebrating more than 20 years of reliability, partnership, and confidence. Explore summaries of five studies sponsored by Medtronic that test the efficacy of the Medtronic Kyphon™ balloon platform.
The EVOLVE study investigated 12-month disability, quality of life, and safety outcomes of VCF patients seen in routine clinical practice. This large, prospective, clinical study demonstrated that kyphoplasty (n = 350) resulted in a statistically significant (p < 0.001) reduction in pain and disability, and improved function and quality of life, across all time points — which matters to patients.
The study also reported that within 1 to 3 months after BKP treatment, patients had outcomes that were close to those estimated prior to the fracture event — and outcomes were statistically significant (p < 0.001) and sustained through 12 months.
Four co-primary endpoints: Numerical Rating Scale back pain (NRS), Oswestry Disability Index (ODI), Short Form 36-question Physical Component Summary (SF-36v2 PCS), EuroQol-5-Domain (EQ-5D) were evaluated for statistically significant improvement 3 months after kyphoplasty.
Single-arm study with no control comparison; 25 percent loss to follow-up at 12 months. Heterogeneity was introduced by including both osteoporotic and neoplastic fractures, but vast majority of subjects (98 percent) had osteoporosis.
This randomized trial compared the efficacy of balloon kyphoplasty (n = 191) with vertebroplasty (n = 190) in patients with osteoporosis and one to three acute fractures. In comparing kyphoplasty and vertebroplasty, the study found:
Lack of patient blinding, substantial loss to follow-up and early termination (404 enrolled out of 1,234 patient enrollment goal), which resulted in lack of statistical power for the primary endpoint.
This randomized, controlled trial at 22 sites in North America, Europe, and Australia assessed the efficacy and safety of balloon kyphoplasty (n = 70) compared with non-surgical management (n = 64) for patients with cancer who had painful VCFs. For BKP patients, the study showed:
Improved Function BKP: baseline 17.6; 1 month 9.1 (within group change p < 0.0001); NSM: baseline 18.2; 1 month 18 (within group change p=0.83). Between group differences at 1 month p < 0.0001.
This Medtronic-sponsored, randomized controlled trial compared Kyphon™ balloon kyphoplasty (n = 149) to non-surgical management (n = 151)* found that people with spinal fractures with osteoporosis treated with Kyphon™ balloon kyphoplasty had:
This multi-center randomized controlled trial compared the safety of BKP (n = 149) with non-surgical management (n = 151) during 24 months in patients with painful VCFs from osteoporosis. The study found that patients with BKP:
Mean improvement across all visits through 24-months was better in BKP vs. NSM:
Non-surgical management included analgesics, bed rest, bracing, physiotherapy, rehabilitation programs, walking aids, calcium and vitamin D supplements, and antiresorptive or anabolic agents.
Schlaich C, et al. Reduced pulmonary function in patients with spinal osteoporotic fractures. Osteoporos Int. 1998;8(3):261-267.
Gold DT. The clinical impact of vertebral fractures: quality of life in women with osteoporosis. Bone. 1996;18(3 Suppl):185S-189S.
Old J , Calvert M. Vertebral compression fractures in the elderly. Am Fam Physician. 2004;69(1):111-116.
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.
Beall DP, Chambers MR, Thomas S, et al. Prospective and multicenter evaluation of outcomes for quality of life and activities of daily living for balloon kyphoplasty in the treatment of vertebral compression fractures: the EVOLVE trial. Neurosurgery. 2019;84:169-178.
Dohm M, Black CM, Dacre A, Tillman JB, Fueredi G, KAVIAR investigators. A randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures due to osteoporosis. AJNR Am J Neuroradiol. 2014;35:2227-2236.
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 Oncology. 2011;12:225-235.
Boonen S, Van Meirhaeghe J, Bastian L, et al. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from randomized trial. J Bone Miner Res. 2011;26:1627-1637.
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;38:971-983.