KYPHON Results from a randomized controlled study comparing KYPHON to nonsurgical care for treatment of vertebral compression fractures Relief. Mobility. Quality of Life.
What is? KYPHON is a minimally invasive procedure designed to repair vertebral compression fractures (VCFs) by reducing and stabilizing the fracture. It has been clinically proven to relieve pain, reduce the fracture and improve patient quality of life. Unlike other treatments, balloon kyphoplasty utilizes orthopaedic balloons to restore vertebral body height and correct angular deformity. The space formed by the balloons after their removal also provide cavities for safe fill of KYPHON bone cement to create an internal cast and stabilize the fracture. Vertebral Compression Fracture (VCF) Balloon-Assisted Fracture Reduction Cavity Creation and Cement Fill Internal Fixation Although the complication rate with KYPHON has been demonstrated to be low, as with most surgical procedures, there are risks associated with the procedure, including serious complications. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events and methods of use, please reference the devices Instructions for Use.
Improving Quality of Life for your Patients Vertebral compression fractures (VCFs), primarily caused by osteoporosis and certain types of cancer, continue to be a significant health concern. Despite the associated spinal deformity, morbidity and decrease in health-related quality of life, 1-5 the majority of the estimated 7, VCFs that occur each year in the United States are undiagnosed and untreated. 7 While the pain from a VCF may be alleviated with analgesics, just one VCF can lead to progressive deformity and subsequent fracture. 8,9 Multiple fractures can result in kyphosis and other physical and health conditions. 1-5 Therefore, early diagnosis and appropriate treatment are important for maintenance of health and quality of life in patients with vertebral fractures. About the Study led study of balloon kyphoplasty vs. nonsurgical care* Conducted in 21 centers in 8 countries 3 patients with 1 to 3 acute painful VCFs due to primary/secondary osteoporosis, multiple myeloma or osteolytic metastatic tumors Patients randomized to balloon kyphoplasty (n=149) and nonsurgical care (n=151) at 1, 3, 6,12 and 24 months Primary endpoint: difference in SF-36 physical component summary (PCS) scale from baseline to 1 month Secondary endpoints: back pain, back function, disability and quality of life measures * Nonsurgical care included analgesics, bed rest, back braces, physiotherapy, rehabilitation programs and walking aids according to standard practices of participating hospitals. In the largest multicenter randomized controlled study on the treatment of VCFs, balloon kyphoplasty was proven to be more effective than nonsurgical care in relieving back pain, restoring back function and improving patient quality of life. 1 The 12 month results from this level I study showed balloon kyphoplasty resulted in faster and significantly greater improvements in quality of life and back function as early as one month after the procedure compared to nonsurgical care of patients suffering from acute painful VCFs. Patients treated with balloon kyphoplasty also reported quicker pain relief, fewer days of limited activity and less use of analgesics or walking aids than those receiving traditional nonsurgical treatments. The benefits of balloon kyphoplasty were sustained on average throughout 12 months. In addition, compared to patients in the control group, patients treated with balloon kyphoplasty did not experience a difference in overall frequency of adverse events or an increase in radiographic subsequent vertebral fracture at 12 months. This study published in The Lancet provides compelling clinical evidence for balloon kyphoplasty as an effective treatment option for patients diagnosed with acute vertebral compression fractures. This study was sponsored by Medtronic. The results support benefits specifically for KYPHON Balloon Kyphoplasty compared to nonsurgical care. 24-month follow-up results to be reported after data analysis is completed.
Faster Pain Relief VCFs can result in debilitating back pain, often requiring the use of narcotic analgesics. 6,1 Patients treated with balloon kyphoplasty reported more immediate relief from back pain with a statistically significant decrease in the use of analgesics compared to the nonsurgical group. Balloon kyphoplasty outcomes compared to control group: Back pain decreased 2.2 points more at 1 week post-procedure (p<.1) and maintained a.9 statistically significant improvement at 12 months (p=.34). Fewer patients reported use of narcotic analgesics between 1 and 6 months (p=.4). At 1 month, 29% of balloon kyphoplasty patients were not using any analgesics compared to only 9% in the nonsurgical group, with almost half of all balloon kyphoplasty patients reporting no usage of analgesics by 12 months. 8 7 6 5 4 3 2 1 Back Pain Score Treatment p<.1 Treatment x visit p<.1 Quicker Return of Mobility VCFs can profoundly affect physical function, making it difficult for patients to perform simple daily activities. 2,5 Patients treated with balloon kyphoplasty had more rapid improvement in back function and mobility, with statistically significant improvements at 1 and 12 months compared to the nonsurgical group. Balloon kyphoplasty outcomes compared to control group: Back function on the Roland-Morris scale significantly improved by 4. points more at 1 month (p<.1) and 2.6 points at 12 months (p=.12). Patients reported less use of walking aids and a mean of 2.5 fewer days of restricted activity per 2 weeks during the year (p<.1). Additionally, patients had an estimated 6 fewer days of limited activity due to back pain over 12 months. 24 2 16 12 8 4 Roland-Morris Score Treatment p<.1 Treatment x visit p<.1 Better Quality of Life Multiple VCFs can result in loss of quality of life comparable to chronic diseases, including stroke and cancer. 1,2 Patients treated with balloon kyphoplasty had statistically greater improvements in quality of life compared to the nonsurgical group as assessed by SF-36 physical component summary (PCS) and EuroQol 5 Domain (EQ-5D), both globally validated measures. Balloon kyphoplasty outcomes compared to control group: The primary endpoint SF-36 PCS score was significantly improved by 5.2 points more from baseline to 1 month (p<.1) and maintained an average 3.5 point improvement throughout the 12 month follow-up period (p=.4). EQ-5D was statistically significantly better by.18 points at 1 month (p=.3) and was maintained at a.12 point improvement at 12 months (p=.252). 5 4 3 2 1 SF-36 PCS Score Treatment p<.1 Treatment x visit p<.1 Comparable Safety Study results showed no significant difference in the overall frequency of adverse events between the balloon kyphoplasty and nonsurgical groups. Two serious adverse events, which occurred postoperatively, were attributed to kyphoplasty: a soft tissue hematoma at the surgical
9 8 Patients Requiring Opioids (%) 7 6 5 4 3 p=.11 p=.9 2 1 p=.2 p=.41 p=.34 14 12 1 Reduced Activity (Days) Treatment p<.1 Treatment x visit p=.1166 8 6 4 2.8 Total EQ-5D Score.7.6.5.4.3.2.1 Treatment p=.9 Treatment x visit p=.8 site and a urinary tract infection that needed intervention. There were no procedure-related or device-related myocardial infarctions, pulmonary embolisms, neurological injuries or deaths associated with balloon kyphoplasty.
References 1. van Schoor NM, Smit JH, Twisk JW, et al. Impact of vertebral deformities, osteoarthritis, and other chronic diseases on quality of life: a population-based study. Osteoporos Int. 25 Jul;16(7):749-56. 2. Silverman SL, Minshall ME, Shen W, et al. The relationship of health-related quality of life to prevalent and incident vertebral fractures in postmenopausal women with osteoporosis: results from the Multiple Outcomes of Raloxifene Evaluation Study. Arthritis Rheum. 21;44:2611-19. 3. Pluijm SM, Tromp AM, Smit JH, et al. Consequences of vertebral deformities in older men and women. J Bone Miner Res. 2;15(8):1564-72. 4. Schlaich C, Minne HW, Bruckner T, et al. Reduced pulmonary function in patients with spinal osteoporotic fractures. Osteoporos Int. 1998;8(3):261-7. 5. Lyles KW, Gold DT, Shipp KM, et al. Association of osteoporotic vertebral compression fractures with impaired functional status. Am J Med. 1993;94(6):595-61. 6. Ledlie JT, Renfro MB. Kyphoplasty treatment of vertebral fractures: 2-year outcomes show sustained benefits. Spine. 26 Jan 1;31(1):57-64. 7. Melton LJ 3rd, Kan SH, Frye MA, et al. Epidemiology of vertebral fractures in women. Am J Epidemiol. 1989 May;129(5):1-11. 8. Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following a fracture. JAMA. 21 Jan;285(3):32-3. 9. Ross PD, Davis JW, Epstein RS, et al. Pre-existing fractures and bone mass predict fracture incidence in women. Annals of Internal Med. 1991;114:919-923. 1. Wardlaw W, Cummings SR, Van Meirhaeghe J, et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. 29; Vol 373. Published on www.thelancet.com on February 24, 29. The physicians referenced may be paid consultants of, and research cited may have been funded partially or in whole by, Medtronic. Medtronic Spinal and Biologics 1221 Crossman Avenue Sunnyvale, CA 9489 USA Telephone: (48) 548-65 Customer Service: (866) 959-7466 For more information about KYPHON, please visit www.kyphon.com or contact your local Medtronic representative at (866) 959-7466. Medtronic Spinal and Biologics 26 Sofamor Danek Drive Memphis, TN 38132 USA 29 Medtronic Spine LLC. All Rights Reserved. 163455-1