EVOLVE—Significant Improvements in Pain, Disability, Quality of Life and Overall Health with Use of Balloon Kyphoplasty for Vertebral Compression Fractures in Medicare-Eligible Patients Despite Minimal Improvements in Vertebral Body Height and Kyphotic Angulation

2017 ◽  
Vol 17 (10) ◽  
pp. S122-S123
Author(s):  
Melissa Chambers ◽  
John Amburgy ◽  
Devin K. Datta ◽  
Richard W. Easton ◽  
Bradly S. Goodman ◽  
...  
Neurosurgery ◽  
2017 ◽  
Vol 64 (CN_suppl_1) ◽  
pp. 244-245
Author(s):  
John Amburgy ◽  
Douglas Beall ◽  
Richard Easton ◽  
Douglas Linville ◽  
Sanjay Talati ◽  
...  

Abstract INTRODUCTION Osteoporotic and neoplastic vertebral compression fractures (VCF) are common and painful. In the U.S., there are more than 1.5 million vertebral fractures annually and 40% of those over the age of 80 will experience this pathology, threatening quality of life and increasing morbidity and mortality. Kyphoplasty is a minimally invasive surgery to stabilize the fracture and recent EVOLVE analysis demonstrated minimal improvement in kypohotic angulation or vertebral body height, however, patients demonstrated significant improvements in pain, disability, quality of life and overall health. METHODS Prospective, multicenter 12-month clinical study of outcomes pertaining to activities of daily living, pain, quality of life, and safety parameters in a Medicare-eligible population treated with kyphoplasty for painful acute or subacute VCFs associated with osteoporosis or cancer. RESULTS >NRS back pain improved from 8.7 (scale 0–10) by 5.2, 5.4, 6.0, 6.2 and 6.3 points, at the 7-day, and the 1, 3, 6 and 12-month time points, respectively. ODI improved from 63.4 (scale 0–100) by 30.5, 35.3, 36.3 and 36.2 points, at the 1, 3, 6 and 12-month time points, respectively. The SF-36 PCS was 24.2 at baseline (scale 0–100) and improved 10.7, 12.4, 13.4 and 13.8 points, at 1, 3, 6 and 12 months. The EQ-5D was 0.383 points (scale 0–1) and improved 0.316, 0.351, 0.356 and 0.358 points, at 1, 3, 6 and 12 months. All measures were statistically significant with P < 0.001 at every time point. Despite these significant improvements in pain, disability, qulity of life and overall health, there were only modest, but significant improvements in kyphotic angulation (1.1° improvement) and vertebral body height (4% improvement). CONCLUSION This large, prospective, multicenter study trial demonstrates that utilization of kyphoplasty for vertebral compression fractures provides significant improvements in pain, disability, quality of life, and overall health despite modest improvements in kyphotic angulation and vertebral body height in Medicare-eligible patients.


2019 ◽  
Vol 10 ◽  
pp. 54 ◽  
Author(s):  
Nancy E. Epstein

Background:Although the majority of patients with traumatic/atraumatic osteoporotic vertebral compression fractures (OVCFs) may be managed with non-surgical treatment (NST), a subset (e.g. 40%) with significant pain, loss of vertebral height, and other factors may warrant percutaneous vertebroplasty (V), or percutaneous kyphoplasty (K).Methods:We compared the impact of these three treatment modalities, V, K, or NST, for managing OVCFs.Results:In several studies, both V and K resulted in comparable improvement in pain relief, postoperative kyphotic angles, increased anterior vertebral heights, and frequency of leakage of bone cement. One study evaluating 16 RCT’s (Randomized Controlled Studies), however, observed K significantly; “decreased the kyphotic wedge angle, increased the postoperative vertebral body height, and decreased the risk of cement leakage vs. V”. Further, in some series, both V and K resulted in higher quality of life scores and better pain relief vs. NST, while other studies showed V was superior to K. Further, although the risk of adjacent level fractures (ALF) following V, K, and NST were comparable in most studies, one clearly demonstrated NST had the lowest incidence of ALF. Despite all these findings, most studies concluded outcomes were comparable for all 3 groups.Conclusions:Although most OVCFs are still managed with non-surgical treatment (NST), a subset (e.g. about 40%) may warrant V or K. Although both V and K have been shown to result in significantly better pain relief, higher quality of life scores, increased postoperative vertebral body height compared with NST, outcomes for all 3 groups remained the same.


2021 ◽  
Author(s):  
Landa Shi ◽  
Dean Chou ◽  
Yuqiang Wang ◽  
Mirwais Alizada ◽  
Yilin Liu

Abstract Objective: to investigate the effect of CT-assisted limited decompression in the management of single segment A3 lumbar burst fracture. Method: A retrospective study of 106 cases with a single-level Magerl type A3 lumbar burst fractures treated with short-segment posterior internal fixation and limited decompression from January 2015 to June 2019 was performed. Patients were divided into two groups: CT-assisted and non-CT-assisted. Perioperative factors, clinical outcomes, postoperative complications, imaging parameters and health-related quality of life (HRQoL) were evaluated. Results: There was no significant difference between the two groups in the kyphosis, anterior vertebral body height loss, posterior vertebral body height loss, operative time, and postoperative complications. The visual analogue score (VAS) and spinal canal encroachment in the CT-assisted group were lower than those in the non-CT-assisted group (P < 0.05). The Japanese Orthopaedic Association score (JOA), the simplified HRQoL scale and American Spinal Injury Association (ASIA) Spinal Cord Injury Grade in the CT-assisted group were higher than those in the non-CT-assisted group (P < 0.05).Conclusion: CT-assisted limited decompression in the treatment of single-segment A3 lumbar burst fracture can achieve better fracture reduction and surgical results, and improve the long-term recovery of neurological function and quality of life of the patients.


2020 ◽  
Author(s):  
Chongqing Xu ◽  
Mengchen Yin ◽  
Wen Mo

Abstract Background The clinical efficacy of vertebroplasty and kyphoplasty treating osteoporotic vertebral compression fractures (OVCF) has been widely recognized in recent years. However, there are also disadvantages of bone cement leakage (BCL), limited correction of kyphosis and recovery of vertebral height. Nowadays, in view of these shortcomings, vesselplasty has been widely used in clinical practice. The objective of this study is to assess its clinical effect and application value for the treatment of OVCF with peripheral wall damage. Methods/Design: All 62 patients (70 vertebrae) treated for OVCF with peripheral wall damage using vesselplasty were involved and retrospectively analyzed. The data collection included operation time, volume of bone cement, relevant surgical complications, visual analog scale (VAS), Oswestry disability index (ODI), vertebral body height and kyphosis Cobb angle. Results The time of operation was 20–65 (34.5 ± 10.5) minutes. The volume of bone cement was 3–8 (5.3 ± 1.3) ml. VAS and ODI at different time points after operation were decreased compared with before operation (all P < 0.05). There were no statistical differences between VAS or ODI at different postoperative time points (P > 0.05). Vertebral body height and Cobb angle at different time points after operation were improved compared with before operation (all P < 0.05). There were no statistical differences between vertebral body height or Cobb angle at different postoperative time points (all P > 0.05). Conclusion Vesselplasty can reduce the risk of BCL and better control the dispersion of bone cement in the treatment of OVCF. It has a definite effect in relieving pain, restoring the vertebral body height and correcting the kyphosis caused by injured vertebrae, especially in OVCF with peripheral wall damage. Therefore, vesselplasty is safe and worthy of clinical application.


2020 ◽  
Vol 11 ◽  
pp. 56
Author(s):  
Mitchell Self ◽  
James Mooney ◽  
John Amburgy ◽  
Bonita Agee ◽  
Leah Schoel ◽  
...  

Background: It has been suggested that greater volumes of cement injected during kyphoplasty correlate with improved vertebral body height restoration and kyphotic angulation correction. However, there is little evidence tying cement volume to patient outcomes. Here, we analyzed the association between cement volume and outcome utilizing indices of pain, disability, and quality of life. Methods: One hundred and thirty-six patients undergoing kyphoplasty were analyzed retrospectively. The total volume of bone cement injected was recorded intraoperatively for each patient; the average total cement volume was 5.44 cc. Pre- and postoperative outcome indices were documented, using the visual analog scale (VAS), Roland-Morris disability index (RMDI), and the EuroQol 5 Dimension instrument (EQ5D). Pearson’s correlations and linear regression models were derived for the association of total cement volume with each of the patient outcome measures. This was a retrospective cohort study. Results: The average change in VAS, RMDI, and EQ5D scores for all patients was −6.8, +8.3, and +0.41, respectively. For VAS, RMDI, and EQ5D improvements, neither Pearson’s correlations nor multiple linear regression models revealed a correlation or an association with total cement volume. Conclusion: For patients undergoing kyphoplasty, outcomes were not associated with the total injected cement volume; all had a significant reduction in pain and most exhibited decreased disability with improved quality of life.


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