A Randomized Trial Comparing 2 Techniques of Balloon Kyphoplasty and Curette Use for Obtaining Vertebral Body Height Restoration and Angular-Deformity Correction in Vertebral Compression Fractures due to Osteoporosis

Abstract

Vertebral compression fractures often result in pain and vertebral deformity. We compared 2 different balloon kyphoplasty techniques both using intraoperative curettage. Adults 50 years of age or older with osteoporosis and 1 acute VCF were randomized to undergo bilateral BKP in which the curette was used first (n = 57) followed by inflatable bone tamps or in which IBTs were used first, followed by curettage and a second IBT inflation (n = 55). Mean procedure duration was 33.5 and 36.8 minutes, and fluoroscopy duration was 3.8 and 3.7 minutes for the CF and IBTF groups, respectively. Two-thirds of VCFs were wedge-shaped, and one-half had dynamic mobility. Anterior height restored postoperatively was 2.28 mm (95% CI, 1.49-3.08 mm; P < .001) and 2.78 mm (95% CI, 1.89-3.66 mm; P < .001) for CF and IBTF groups, representing ∼35% and 39% of lost height restored, but group differences were not significant (P = .4). Intraoperative anterior height gain attributed to dynamic mobility was 2.96 mm (95% CI, 1.92-4.00 mm; P < .001) and 3.05 mm (95% CI, 2.10-4.00 mm; P < .001); additional height attributed to IBT inflation was 1.09 mm (95% CI, 0.77-1.41 mm; P < .001) and 1.25 mm (95% CI, 0.68-1.82 mm; P < .001), representing a 37% and 41% increase. There was no significant height loss on IBT removal and cementation. Both groups had improved pain and ambulation. Asymptomatic leakage occurred in 15% of VCFs. There was 1 nonserious device-related hematoma (IBTF group). One new clinical VCF occurred in each group, but they were not device-related. Both techniques resulted in significant vertebral body height and pain improvement. Procedure and adverse event data demonstrated safe curette use in conjunction with balloon kyphoplasty procedures.