OBJECTIVE: To evaluate the clinical efficacy of percutaneous bipediculary kyphoplasty with double or single balloon I treatment of osteoporosis vertebral compressive fractures. METHODS:Fifty-one patients with painful osteoporotic vertebral compressive fracture involving 69 vertebrae. 19 males and 32 females, aged 72.5 (63 - 85), underwentpercutaneous kyphoplasty with double inflatable balloon (29 cases, 38 vertebrae) or single inflatable balloon (22 cases, 31 vertebrae) under X-ray fluoroscopy monitoring. The fractured vertebral bodies were punctuated, balloon was put into the subsided areas and then distended, and bone cement was injected into the cavity. The vertebral height and Cobb angle, preoperative and postoperative, were measured by radiography. Follow-up was conducted for 6 - 12 months. RESULTS: All patients tolerated the procedure well with dramatic pain relief within 96 hours after the procedure. No clinical complication was found. Visual analog scale score was improved from 7.8 preoperatively to 2.6 postoperatively (P < 0.01). Oswestry disability index was decreased from 73% preoperatively to 26% postoperatively. In the double balloon group, the heights loss of the anterior and middle portions of the vertebral body reduced from 14.7 mm and 10.5 mm to 10.1 mm and 5.5 mm respectively (both P < 0.01), and the Cobb angle was corrected from 22.4 degrees to 12.3 degrees (P < 0.01). In the single balloon group, the heights loss of the anterior and middle portions of the vertebral body reduced from 14.7 mm and 10.6 mm to 10.4 mm and 6.5 mm respectively (both P < 0.01), and the. Cobb angle was corrected averagely from 21.2 degrees to 11.6 degrees (P < 0.01). The mean vertebral height restoration rates were 72.8% and 70.1% in the double and single balloon groups respectively. The mean Cobb angle correct degrees were 10.1 degrees and 9.5 degrees in double and single balloon groups respectively. There were no significant differences in the average height restoration rate and Cobb angle correction between the double and single balloon groups (72.8% vs 70.1%, and 10.0 degrees vs 9.5 degrees both P > 0.05). The pain relief and functional recovery were substantial and maintained to the last follow up. CONCLUSION:Percutaneous bipediculary kyphoplasty with double or single balloon for painful osteoporotic vertebral body compressive fractures is effective and safe.
RCT Entities:
OBJECTIVE: To evaluate the clinical efficacy of percutaneous bipediculary kyphoplasty with double or single balloon I treatment of osteoporosis vertebral compressive fractures. METHODS: Fifty-one patients with painful osteoporotic vertebral compressive fracture involving 69 vertebrae. 19 males and 32 females, aged 72.5 (63 - 85), underwent percutaneous kyphoplasty with double inflatable balloon (29 cases, 38 vertebrae) or single inflatable balloon (22 cases, 31 vertebrae) under X-ray fluoroscopy monitoring. The fractured vertebral bodies were punctuated, balloon was put into the subsided areas and then distended, and bone cement was injected into the cavity. The vertebral height and Cobb angle, preoperative and postoperative, were measured by radiography. Follow-up was conducted for 6 - 12 months. RESULTS: All patients tolerated the procedure well with dramatic pain relief within 96 hours after the procedure. No clinical complication was found. Visual analog scale score was improved from 7.8 preoperatively to 2.6 postoperatively (P < 0.01). Oswestry disability index was decreased from 73% preoperatively to 26% postoperatively. In the double balloon group, the heights loss of the anterior and middle portions of the vertebral body reduced from 14.7 mm and 10.5 mm to 10.1 mm and 5.5 mm respectively (both P < 0.01), and the Cobb angle was corrected from 22.4 degrees to 12.3 degrees (P < 0.01). In the single balloon group, the heights loss of the anterior and middle portions of the vertebral body reduced from 14.7 mm and 10.6 mm to 10.4 mm and 6.5 mm respectively (both P < 0.01), and the. Cobb angle was corrected averagely from 21.2 degrees to 11.6 degrees (P < 0.01). The mean vertebral height restoration rates were 72.8% and 70.1% in the double and single balloon groups respectively. The mean Cobb angle correct degrees were 10.1 degrees and 9.5 degrees in double and single balloon groups respectively. There were no significant differences in the average height restoration rate and Cobb angle correction between the double and single balloon groups (72.8% vs 70.1%, and 10.0 degrees vs 9.5 degrees both P > 0.05). The pain relief and functional recovery were substantial and maintained to the last follow up. CONCLUSION: Percutaneous bipediculary kyphoplasty with double or single balloon for painful osteoporotic vertebral body compressive fractures is effective and safe.