Chun-Jing He1, Guo-Dong Liu2. 1. Department of Pain, People's Hospital of Guizhou Province, Guiyang 550002, China. 2. 8th Department, Research Institute of Surgery, Daping Hospital, Third Military Medical University, Chongqing 400042, China.
Abstract
BACKGROUND:Bone cement leakage in patients with vertebral fracture limits the use of percutaneous kyphoplasty (PKP) and percutaneous vertebroplasty (PVP). Finding a method to reduce bone cement leakage is clinically rather important. OBJECTIVE: To compare the efficacy and safety of bone-filling mesh containers (BFMCS) and simple percutaneous balloon kyphoplasty in the treatment of osteoporotic vertebral compression fractures. STUDY DESIGN: A randomized controlled clinical study discussing the effect of 3 methods in the treatment of vertebral fractures. METHODS:From October 2014 to August 2015, 80 patients with single osteoporotic vertebral compression fractures were admitted in our hospital, including 31 men and 49 women with an average age of 76.2 years (range, 63-82 years). Patients were divided into a percutaneous balloon kyphoplasty group (Group A) and a PVP with dilated balloon placement group (Group B), with 40 cases in each group. The visual analog scale (VAS), Oswestry disability index (ODI), height of the vertebral body and Cobb's angle of the injured vertebrae were observed before operation and at 1 day, 1 month, and 6 months after the operation. Bone cement leakage and postoperative complications were also observed. RESULTS: Operations were successfully completed in all 80 patients without pulmonary embolism and without spinal cord or nerve root injury. The operation time was (32.6 ± 6.1) minutes in Group A and (31.8 ± 5.8) minutes in Group B. Operation time did not significantly differ between the 2 groups (P > 0.05). Both groups differed significantly when comparing the results with those measured before treatment. In Group A, the ODIs before operation and at 1 day, 1 month, and 6 months after the operation were 84.125 ± 8.821, 29.300 ± 8.951, 16.175 ± 6.748, and 11.400 ± 6.164, respectively, and those in Group B were 84.300 ± 8.768, 29.200 ± 9.121, 15.975 ± 6.811, and 11.575 ± 6.460, respectively. Cobb's angle values in Group A before and after treatment were (19.225 ± 5.881)° and (13.900 ± 3.720)°, respectively, and those in Group B were (19.275 ± 6.210)° and (14.225 ± 4.016)°, respectively. CONCLUSION: Both bone-filling mesh bag and simple percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures can relieve pain effectively and correct the Cobb angle. The bone-filling mesh container can effectively prevent bone cement leakage and reduce the incidence of bone cement leakage. LIMITATIONS: The study has limitations due to the small number of cases and short period of follow-up time. Further studies are needed to determine whether the mesh bag can limit the distribution of bone cement within the vertebral body. KEY WORDS: Bone-filling mesh container, kyphoplasty, osteoporosis, vertebral compression fracture.
RCT Entities:
BACKGROUND: Bone cement leakage in patients with vertebral fracture limits the use of percutaneous kyphoplasty (PKP) and percutaneous vertebroplasty (PVP). Finding a method to reduce bone cement leakage is clinically rather important. OBJECTIVE: To compare the efficacy and safety of bone-filling mesh containers (BFMCS) and simple percutaneous balloon kyphoplasty in the treatment of osteoporotic vertebral compression fractures. STUDY DESIGN: A randomized controlled clinical study discussing the effect of 3 methods in the treatment of vertebral fractures. METHODS: From October 2014 to August 2015, 80 patients with single osteoporotic vertebral compression fractures were admitted in our hospital, including 31 men and 49 women with an average age of 76.2 years (range, 63-82 years). Patients were divided into a percutaneous balloon kyphoplasty group (Group A) and a PVP with dilated balloon placement group (Group B), with 40 cases in each group. The visual analog scale (VAS), Oswestry disability index (ODI), height of the vertebral body and Cobb's angle of the injured vertebrae were observed before operation and at 1 day, 1 month, and 6 months after the operation. Bone cement leakage and postoperative complications were also observed. RESULTS: Operations were successfully completed in all 80 patients without pulmonary embolism and without spinal cord or nerve root injury. The operation time was (32.6 ± 6.1) minutes in Group A and (31.8 ± 5.8) minutes in Group B. Operation time did not significantly differ between the 2 groups (P > 0.05). Both groups differed significantly when comparing the results with those measured before treatment. In Group A, the ODIs before operation and at 1 day, 1 month, and 6 months after the operation were 84.125 ± 8.821, 29.300 ± 8.951, 16.175 ± 6.748, and 11.400 ± 6.164, respectively, and those in Group B were 84.300 ± 8.768, 29.200 ± 9.121, 15.975 ± 6.811, and 11.575 ± 6.460, respectively. Cobb's angle values in Group A before and after treatment were (19.225 ± 5.881)° and (13.900 ± 3.720)°, respectively, and those in Group B were (19.275 ± 6.210)° and (14.225 ± 4.016)°, respectively. CONCLUSION: Both bone-filling mesh bag and simple percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures can relieve pain effectively and correct the Cobb angle. The bone-filling mesh container can effectively prevent bone cement leakage and reduce the incidence of bone cement leakage. LIMITATIONS: The study has limitations due to the small number of cases and short period of follow-up time. Further studies are needed to determine whether the mesh bag can limit the distribution of bone cement within the vertebral body. KEY WORDS: Bone-filling mesh container, kyphoplasty, osteoporosis, vertebral compression fracture.