A Randomized Trial of Balloon Kyphoplasty and Nonsurgical Management for Treating Acute Vertebral Compression Fractures

Abstract

Balloon kyphoplasty rapidly reduces pain and improves function, disability, and QOL over the course of two years compared with non-surgical management; the reduction in pain, EQ-5D QOL, patient satisfaction, and kyphotic angulation remain statistically significant at all time points. Peri-operative complications may be reduced with more care in patient positioning.

A Randomized Trial Comparing Balloon Kyphoplasty and Vertebroplasty for Vertebral Compression Fractures due to Osteoporosis

“…BKP was performed by using a bilateral approach as previously described (Kyphon Osteo Introducer Systems, Inflatable Bone Tamps, HV-R Bone Cement, Bone Filler Devices, and other BKP devices were manufactured by Medtronic Spine, Sunnyvale, California). [4][5][6]14 VP was performed according to local practices. The primary end points were 12-and 24-month new radiographic VCF (including any new or worsening index fracture) incidence by using the method of Genant et al 15 Originally, the 1234 enrollment goal stemmed from an 8.7% difference in subsequent radiographic fracture (40% in VP, 31.3% in BKP), 20%…”

“…Balloon kyphoplasty uses orthopedic inflatable bone tamps before bone cement injection in an attempt to correct vertebral deformity and control cement distribution. [4][5][6] Vertebroplasty is similar, using needles to deliver bone cement without orthopedic balloons. 7 When Kyphoplasty and Vertebroplasty In the Augmentation and Restoration of vertebral body compression fractures (KAVIAR) was initiated, no comparative randomized controlled trials (RCTs) existed, and evidence remains limited.…”

Racial and Health Insurance Disparities of Inpatient Spine Augmentation for Osteoporotic Vertebral Fractures from 2005 to 2010

“…5,[10][11][12][13][14][15] These current findings are potentially clinically relevant because prior studies have shown that patients receiving spine augmentation procedures demonstrate improved survival and quality of life compared with patients receiving nonoperative treatment. 16,17 In a study of the 2006 Medicare Provider Analysis and Review File data base, Chen et al 16 demonstrated that patients who underwent vertebroplasty and kyphoplasty had significantly higher 3-year survival rates compared with patients receiving nonoperative management. The Fracture Reduction Evaluation study, which randomized patients into balloon kyphoplasty and nonsurgical management, demonstrated that kyphoplasty was associated with improved quality of life.…”

“…The Fracture Reduction Evaluation study, which randomized patients into balloon kyphoplasty and nonsurgical management, demonstrated that kyphoplasty was associated with improved quality of life. 17 While this study was not designed to determine the specific causes behind racial and insurance-based disparities, we believe that the causes of such disparities are multiple, including but not limited to physician bias, access to care, patient preferences, and communication barriers. [18][19][20][21][22][23] While high costs of spine augmentation procedures could contribute to the lower rates of spine augmentation in some groups, our subgroup analysis of patients with Medicare demonstrated that racial minorities still had lower rates of spine augmentation despite having the same type of insurance as their white counterparts.…”

Improvement in Pulmonary Function of Chronic Obstructive Pulmonary Disease (COPD) Patients With Osteoporotic Vertebral Compression Fractures (OVCFs) After Kyphoplasty Under Local Anesthesia

“…8 BKP improves patient quality of life and results in a significantly reduction in LKA. 11,12,16 Although KP poses low surgical risk, the elderly patient population presents substantial anesthetic risk because of multiple comorbidities. COPD is one of the most common and severe comorbidities that require careful preoperative medical assessment and optimization.…”