Liang Chen1, Huilin Yang, Tiansi Tang. 1. Department of Orthopaedic Surgery, The First Affiliated Hospital of Suzhou University, Suzhou, People's Republic of China.
Abstract
STUDY DESIGN: A prospective study of patients who underwent multilevel balloon kyphoplasty at a single institute. OBJECTIVE: To examine and compare the safety and long-term radiographic and clinical effects of unilateral or bilateral balloon kyphoplasty to treat multilevel symptomatic vertebral compression fractures. SUMMARY OF BACKGROUND DATA: Typically, balloon kyphoplasty involves placement of inflatable bone tamp via a bilateral transpedicular or extrapedicular approach. Recently, several articles reported unilateral kyphoplasty with comparable outcomes. However, few prospective randomized study comparing the radiographic and clinical outcomes using unilateral and bilateral approaches was reported. METHODS.: Forty-nine patients with 114 Osteoporotic vertebral compression fractures were randomly allocated into two groups adopting unilateral or bilateral balloon kyphoplasty. Preoperative and postoperative pain scores, back disability, and 36-Item Short Form Health Survey scores were compared with at least a 2-year follow-up. Vertebral body height and vertebral body kyphotic angle from this cohort were analyzed before surgery, after surgery, and at final follow-up. RESULTS: Both unilateral and bilateral balloon kyphoplasty resulted in significant pain reduction and back dysfunction improvement and remained unchanged at final follow-up. Quality of life assessment using 36-Item Short Form Health Survey recorded marked and significant improvements in all mean subscale scores except general health and social function. Regarding the pain reduction, back dysfunction, and 36-Item Short Form Health Survey scores, no significant difference existed between two groups. Significant increases of anterior and middle vertebral heights were recorded for both groups after surgery and maintained for the period of follow-up. The mean correction of vertebral body kyphotic angle was about 7° in both groups. Asymptomatic cement extravasation occurred in six of 49 of patients, and three patients developed additional fractures at untreated levels during the period of follow-up. CONCLUSIONS: Both unilateral and bilateral kyphoplasty markedly improve symptom-related clinical effects of multilevel vertebral compression fractures and result in significant vertebral height restoration and kyphosis correction that remains stable for at least 2 years after treatment.
RCT Entities:
STUDY DESIGN: A prospective study of patients who underwent multilevel balloon kyphoplasty at a single institute. OBJECTIVE: To examine and compare the safety and long-term radiographic and clinical effects of unilateral or bilateral balloon kyphoplasty to treat multilevel symptomatic vertebral compression fractures. SUMMARY OF BACKGROUND DATA: Typically, balloon kyphoplasty involves placement of inflatable bone tamp via a bilateral transpedicular or extrapedicular approach. Recently, several articles reported unilateral kyphoplasty with comparable outcomes. However, few prospective randomized study comparing the radiographic and clinical outcomes using unilateral and bilateral approaches was reported. METHODS.: Forty-nine patients with 114 Osteoporotic vertebral compression fractures were randomly allocated into two groups adopting unilateral or bilateral balloon kyphoplasty. Preoperative and postoperative pain scores, back disability, and 36-Item Short Form Health Survey scores were compared with at least a 2-year follow-up. Vertebral body height and vertebral body kyphotic angle from this cohort were analyzed before surgery, after surgery, and at final follow-up. RESULTS: Both unilateral and bilateral balloon kyphoplasty resulted in significant pain reduction and back dysfunction improvement and remained unchanged at final follow-up. Quality of life assessment using 36-Item Short Form Health Survey recorded marked and significant improvements in all mean subscale scores except general health and social function. Regarding the pain reduction, back dysfunction, and 36-Item Short Form Health Survey scores, no significant difference existed between two groups. Significant increases of anterior and middle vertebral heights were recorded for both groups after surgery and maintained for the period of follow-up. The mean correction of vertebral body kyphotic angle was about 7° in both groups. Asymptomatic cement extravasation occurred in six of 49 of patients, and three patients developed additional fractures at untreated levels during the period of follow-up. CONCLUSIONS: Both unilateral and bilateral kyphoplasty markedly improve symptom-related clinical effects of multilevel vertebral compression fractures and result in significant vertebral height restoration and kyphosis correction that remains stable for at least 2 years after treatment.