Balloon Kyphoplasty in the Treatment of Vertebral Compression Fractures in Cancer Patients

2012 ◽  
Vol 08 (03) ◽  
pp. 144
Author(s):  
Leonard Bastian ◽  
Keyword(s):  
Body Height ◽  
Balloon Kyphoplasty ◽  
Controlled Study ◽  
Vertebral Compression Fractures ◽  
Effective Treatment Option ◽  
Cancer Data ◽  
Compression Fractures ◽  
Patients With Cancer ◽  
Increased Risk ◽  
Fracture Management

Patients with cancer are at increased risk of painful vertebral compression fractures (VCFs). The Cancer Patient Fracture Evaluation (CAFE) trial was the first randomised controlled study to compare the safety and effectiveness of balloon kyphoplasty (BKP – a minimally invasive procedure) with non-surgical fracture management in the treatment of VCFs in patients with cancer. Data from the CAFE trial demonstrated that BKP is a safe and effective treatment option that quickly reduces pain and improves physical function and vertebral body height in patients with cancer and painful VCFs. Data from peer-reviewed published studies support the CAFE trial findings.

Balloon Kyphoplasty Improves Both Roland-Morris Disability Scores and Bone Pain among Cancer Patients with Vertebral Compression Fractures: Interim Analysis of Results from a Phase IV Random Trial

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3695-3695
Author(s):  
James R. Berenson ◽  
John B Tillman ◽  
Mohamad A. Hussein ◽  
Robert Pflugmacher ◽  
Peter Jarzem ◽  
...  
Keyword(s):  
Back Pain ◽  
Adverse Events ◽  
Cancer Patients ◽  
Interim Analysis ◽  
Balloon Kyphoplasty ◽  
The United States ◽  
Vertebral Compression Fractures ◽  
Serious Adverse Events ◽  
Compression Fractures ◽  
Patients With Cancer

Abstract Destructive vertebral lesions are a common source of morbidity among patients with cancer. Balloon kyphoplasty is a minimally invasive surgical procedure performed for patients with painful vertebral compression fractures (VCFs) with the goal of reducing pain and disability and improving quality of life. We report the results of the first randomized trial among cancer patients with VCFs to assess the efficacy and safety of this procedure. Twenty-one sites in Europe, the United States, Canada and Australia enrolled 134 patients after consent and ethical review board approval. Adult patients diagnosed with a variety of cancers and ≤ 3 painful VCFs (VAS ≥ 4) were randomly assigned to immediate kyphoplasty (N=70) or nonsurgical supportive care (N=64). Patients with primary bone tumors, osteoblastic tumors or solitary plasmacytoma at the fracture site were excluded as well as patients with spinal cord compression. The primary objective was to determine the change in the Roland-Morris Disability questionnaire, a 0- (no disability) to 24-point (maximum disability) instrument validated for assessing back-specific physical functioning, at one month. Back pain was also assessed using a validated 0- (no pain) to 10-point (worst pain imaginable) numerical rating scale. Data from a preplanned interim analysis of this ongoing study are now reported. For pain and function, patients with complete data that has been evaluated through one month are included whereas all enrolled patients were analyzed for safety. Mean patient age was 64 years (range 37 to 88), 58% were female, and tumor types included multiple myeloma (36%), cancers of the breast (20%), lung (8%), prostate (6%) and other sites (30%). At study enrollment, 23% of patients were on daily corticosteroids and 48% had received bisphosphonates within 12 months of study entry. Prior to randomization, single VCFs were identified by the local investigators in 43% of patients; an equal proportion (29%) of patients had 2 or 3 fractures. Among the kyphoplasty and nonsurgical cohorts, 59 and 56 subjects, respectively were evaluable for the efficacy analysis. At baseline, average Roland-Morris scores were similar between the groups; 17.7 and 18.3 points for kyphoplasty and non-surgical-treated patients, respectively. However, at one month, there were marked differences between the two groups with a mean improvement for patients randomized to kyphoplasty of −8.3 points (95% CI −6.2 to −10.5) whereas those receiving non-surgical care showed no significant change (−0.1 points, 95% CI 0.9 to −1.0; p<0.0001 for difference). Mean baseline pain scores were also not different between the two groups (7.2 and 7.3 points for the kyphoplasty and nonsurgical groups, respectively). At one week, kyphoplasty-treated patients showed significant improvement in their back pain (−3.6 points, 95%CI, −2.8 to −4.4) whereas those patients treated non-surgically had no change in their pain (−0.3 points, 95%CI, 0.1 to −0.8; p<0.0001 for difference). Similar results for pain were obtained at one month; kyphoplasty resulted in a −4.1 point change (95%CI, −3.2 to −4.9) and those patients treated non-surgically had no change in their pain (−0.5 points; 95%CI, 0.04 to −1.0; p<0.0001 for difference). There was no significant difference in the number of patients with serious adverse events between the kyphoplasty (16) and nonsurgical (10) groups at one month. None of the serious adverse events in the kyphoplasty group were related to the devices used, including bone cement extravasation; one serious adverse event in the form of an intra-operative non-Q-wave myocardial infarction resolved and was attributed to anesthesia. This randomized study shows, at a pre-planned interim analysis time point, that patients with cancer-related VCFs treated with immediate balloon kyphoplasty show a marked reduction in back disability and pain at one month compared to non-surgical treatment. Pain reduction was also statistically significantly improved within one week postoperatively. Importantly, minimally clinically important differences for the Roland-Morris and pain scales used in this trial have been determined from previous studies and are estimated to be approximately 2.5 and 2.0 points, respectively. Thus, these improvements in disability and pain with balloon kyphoplasty were both statistically and clinically significant and achieved without an increase in adverse events.

173 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 an

Neurosurgery ◽  
2017 ◽  
Vol 64 (CN_suppl_1) ◽  
pp. 244-245
Author(s):  
John Amburgy ◽  
Douglas Beall ◽  
Richard Easton ◽  
Douglas Linville ◽  
Sanjay Talati ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Vertebral Body ◽  
Body Height ◽  
Balloon Kyphoplasty ◽  
Vertebral Compression Fractures ◽  
Vertebral Body Height ◽  
Compression Fractures ◽  
Time Points ◽  
Pain Disability

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.

scholarly journals Comparison of Outcomes and Complications Among Various Surgical Treatments for Vertebral Compression Fractures: a Retrospective Study.

2021 ◽  
Author(s):  
Kuei-Lin Yeh ◽  
Szu-Hsien Wu ◽  
Shing-Sheng Wu ◽  
Sheng-Mou Hou
Keyword(s):  
Body Height ◽  
Compression Fracture ◽  
Balloon Kyphoplasty ◽  
Cement Leakage ◽  
Vertebral Compression Fractures ◽  
Fracture Rate ◽  
Kyphotic Angle ◽  
Compression Fractures ◽  
Scale Scores ◽  
Average Body

Abstract BackgroundOsteoporosis with vertebral compression fractures is increasingly common in the elderly. As no studies have compared the safety and efficacy of surgical techniques for the treatment of such fractures, we retrospectively compared vertebroplasty, balloon kyphoplasty, and kyphoplasty with SpineJack or an intravertebral expandable pillar (IVEP). In this study, we retrospectively compared the safety and efficacy, including visual analog scale scores for pain, kyphotic angle, average body height, rate of cement leakage, and occurrence of adjacent vertebral compression fractures of each surgical intervention mentioned above at Shin-Kong Wu Ho-Su Memorial Hospital. All patients underwent surgical treatment under Dr. Wu. MethodsWe retrospectively analyzed 10 years of data of 354 patients with vertebral compression fractures, randomly dividing them into five groups. All these patients were diagnosed with fresh compression fracture, defined as signal changes on T1 phase by magnetic resonance imaging examination. Their visual analog scale scores for pain, kyphotic angle, average body height, rate of cement leakage, and occurrence of adjacent vertebral compression fractures were followed up for 1 year. ANOVA, the post hoc Bonferroni test, and Fisher’s exact probability test were used for statistical analyses.ResultsAll pain scores significantly improved 12 months postoperatively; however, there was no significant difference between the groups. Kyphoplasty with SpineJack significantly reduced the kyphotic angle, restoring the vertebral body height; adjacent compression fracture rate was highest in the vertebroplasty group (p=0.020). The method with the lowest cement leakage rate remains unidentified due to the small sample size; however, kyphoplasty with SpineJack, intravertebral expandable pillar, and vesselplasty resulted in lower rates than balloon kyphoplasty or vertebroplasty.ConclusionsVertebroplasty and kyphoplasty were excellent treatments for vertebral compression fractures, with no differences in pain relief. Kyphoplasty with SpineJack entailed a lower risk of cement extravasation, resulting in greater vertebral body height restoration and kyphotic reduction than other groups. While the safest method remains unclear, Kyphoplasty with SpineJack, intravertebral expandable pillar, and vesselplasty resulted in low rates of cement leakage. Kyphoplasty with intravertebral expandable pillar resulted in the lowest adjacent compression fracture rate.

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