scholarly journals Comparison of Balloon Kyphoplasty with the New Kiva® VCF System for the Treatment of Vertebral Compression Fractures

2013 ◽  
Vol 5;16 (5;9) ◽  
pp. E505-E512
Author(s):  
Lucia Otten

Background: Vertebral compression fractures are common among the elderly, which is conditioned by osteoporosis. They cause back pain and limit the patient’s activities. The Kiva® VCF Treatment System is a new device to treat vertebral compression fractures. Compared to other methods, the utilization of the Kiva System reduces the risk for complications and delivers improvements in back pain reduction and functionality. Objectives: Evaluation of safety and effectiveness of the Kiva System in comparison to balloon kyphoplasty on the basis of matched pairs. Methods: 52 patients (47 - 89 years, 68 fractures) were treated with balloon kyphoplasty or with the new Kiva System. Back pain and impairment of motility were assessed preoperatively and 6 months postoperatively, with the Visual Analog Scale (VAS) and Oswestry Disability Index (ODI). The operation time and cement extravasation were recorded. Control radiographs were evaluated for new fractures and vertebral heights. Results: Mean VAS values in both groups improved from preoperatively 87.6 ± 12.8 and 83.1 ± 14.9 to 10.8 ± 20.8 and 24.6 ± 11.0 6 months after the treatment. The improvement after 6 months in the Kiva group was significantly better than in the balloon kyphoplasty group (P < 0.0001). Mean ODI scores in both groups also improved from 68.7% ± 15.8% in the Kiva group and 80.6% ± 8.6% in the balloon kyphoplasty group preoperatively to 24.8 ± 18.6% and 33.2 ± 6.3% 6 months after treatment. The mean operation time for the Kiva group was 12.7 ± 3.7 minutes per vertebra and cement leakage occurred in 6 patients. The mean operation time for the balloon kyphoplasty group was 34.1 ± 7.0 minutes per vertebra and cement leakage occurred in 8 patients. Anterior and mid vertebral height in the Kiva group increased from preoperatively 21.06 ± 7.44 mm and 18.36 ± 5.64 mm to postoperatively 22.41 ± 7.14 mm and 20.41 ± 6.00 mm. Anterior and mid vertebral height in the balloon kyphoplasty group increased from preoperatively 21.68 ± 2.06 mm and 21.97 ± 1.78 mm to postoperatively 25.09 ± 2.54 mm and 25.29 ± 2.10 mm. Vertebral height restoration could be therefore maintained with both procedures for 6 months. In the Kiva group 2 cases of nonadjacent fractures and one case of adjacent fractures were observed. In the balloon kyphoplasty group 9 cases of adjacent, as well as 5 cases of nonadjacent, fractures were observed. In the Kiva group significant fewer fractures occurred. Limitations: The study includes only 26 patients for each procedure, which were compared on the basis of matched pairs. Conclusion: The Kiva System appears to be a safe and effective procedure for the treatment of vertebral compression fractures. Six months after treatment with the Kiva System, better VAS values than the values after the treatment with balloon kyphoplasty were recorded. Reduction in functional impairment was as successful as it was after balloon kyphoplasty. Vertebral height restoration was observed in both groups, which was sustained for 6 months. The risk of cement extravasation during the Kiva Treatment is nearly the same as in balloon kyphoplasty; however, it requires a shorter operation time and produces fewer new fractures. Key words: Vertebral compression fracture, Kiva, kyphoplasty, vertebral augmentation, osteoporosis, back pain

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Hongyu Wei ◽  
Chunke Dong ◽  
Yuting Zhu ◽  
Haoning Ma

Abstract Background A systematic review and meta-analysis to assess the pros and cons of percutaneous vertebroplasty (PVP) versus kyphoplasty (PKP) for osteoporotic vertebral compression fractures (OVCFs) with intravertebral cleft (IVC) including all available evidence from controlled trials. Methods Databases including Pubmed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), and Wanfang Data were searched to identify relevant studies comparing PVP and PKP for OVCFs with IVC. The outcomes mainly included visual analog scale (VAS), Oswestry Disability Index (ODI), local kyphotic angle (LKA), rate of vertebral height (VH%), and adverse events. Results Nine studies enrolling 688 patients were eligible for meta-analysis. The results indicated no significant differences between the two groups in the short-and long-term VAS, ODI, LKA, or VH% (P > 0.05). Compared with PVP, PKP was associated with significantly longer operation time (P < 0.05), higher cost (P > 0.05), and more injected cement volume (P < 0.05). In terms of adverse events, PKP has a lower risk of cement leakage (P < 0.05), while with no significant difference in adjacent-level fracture rates (P > 0.05). Conclusion The two procedures have similar short- and long-term pain relief, functional recovery, local kyphosis correction, and vertebral height maintenance in OVCFs with IVC. PKP is superior to PVP for the injected cement volume, and lower cement leakage rate, however, with longer operation time, more fluoroscopy times, and higher cost. Further randomized controlled trials (RCTs) should be conducted to confirm these results.


2005 ◽  
Vol 18 (3) ◽  
pp. 1-4 ◽  
Author(s):  
H. Gordon Deen ◽  
Jaime Aranda-Michel ◽  
Ronald Reimer ◽  
John D. Putzke

Object Organ transplant recipients are at risk for vertebral compression fractures (VCFs). The goal of this study was to determine whether kyphoplasty is an effective treatment for VCFs that develop in this patient population. Methods Six consecutive patients who had undergone an organ transplant (five liver and one kidney transplant) had a total of 13 symptomatic VCFs that were treated with balloon kyphoplasty. Postprocedure follow-up duration ranged from 6 to 12 months. The mean visual analog scale pain score was 9.3 before treatment and declined to 1.8 after treatment. This improvement was highly significant (p < 0.001). Intake of narcotic drugs decreased or was eliminated in all patients, and there were no complications related to the procedure. There was one instance of clinically insignificant extraosseous cement extravasation. Sagittal alignment was improved by 5° in one patient and was unchanged in the remaining five. During the follow-up period, a new fracture developed adjacent to a treated level in one patient. This was successfully treated with an additional kyphoplasty procedure. Conclusions Kyphoplasty can be performed safely in organ transplant recipients with VCF, in whom results are just as favorable as those seen in patients with no history of organ transplantation.


2010 ◽  
Vol 16 (1) ◽  
pp. 65-70 ◽  
Author(s):  
T. Yang ◽  
S. Liu ◽  
X. Lv ◽  
Z. Wu

We reviewed the effectiveness of balloon kyphoplasty in the treatment of acute symptomatic vertebral compression fractures. We assessed radiographic and functional outcome in 11 patients with a 24.3 month follow-up from a retrospectively monitored series of 11 patients who underwent balloon kyphoplasty (BKP). A visual analogue scale (VAS) and the short McGill questionnaire (MPQ) were used to assess average symptoms. Eleven patients with 19 treated vertebrae completed the study. The VAS showed significant improvement after treatment: the initial score was 9.1 ± 0.6 (mean ± SD), falling to 2.7 ± 1.07 by 24.3 months (P<0.001). The MPQ also showed a significant improvement (P<0.001) at follow-up. A new fracture was seen in one patient affecting two vertebrae adjacent to the treated level. On CT following the procedure, there was cement leakage in the disc in 9% of cases. BKP is a minimally invasive procedure that has been shown to be effective in the treatment of acute symptomatic vertebral compression fractures. It appears that BKP is associated with a low incidence of procedure-related complications and cement extravasation.


2015 ◽  
Vol 2;18 (2;3) ◽  
pp. E187-E194
Author(s):  
Lin Nie

Background: Percutaneous vertebroplasty is a widely used vertebral augmentation procedure for treating osteoporotic vertebral compression fractures (OVCFs). But high cement leakage rate caused by a low-viscosity cement and high injection pressure has limited its general use. Balloon kyphoplasty (BKP) and high-viscosity cement vertebroplasty (HVCV) are 2 modifications of vertebroplasty designed to decrease cement leakage. Objective: To assess the safety and efficacy of HVCV compared with BKP. Study Design: A prospective cohort study. Setting: Department of Spine Surgery, an affiliated hospital of a medical university. Method: One hundred seven patients suffering from painful OVCFs were randomly assigned into HVCV or BKP groups. Visual Analog Scale (VAS), Oswestry Disability Index (ODI), cement leakage, and vertebral height restoration were evaluated. All occurring complications and injected cement volumes were recorded. The follow-up time was one year. Results: VAS and ODI scores improved in both groups, and did not differ significantly between the 2 groups. More cement was used in the BKP group than in HVCV group (4.22 vs. 3.31 mL, P < 0.0001). The incidence of cement leakage in the HVCV group was lower than that of the BKP group (13.24% vs 30.56%, P < 0.05). No symptomatic cement leakages occurred in the HVCV group. In the BKP group, one patient experienced discogenic back pain related to a disc leak, and another patient had asymptomatic cement emboli in the lung related to venous leakage. The mean compression rate before the procedure was 29.98% in the HVCV group and 28.67% in the BKP group (P = 0.94). The vertebral height was improved significantly and maintained at one-year follow-up in both groups. BKP was more effective in vertebral height restoration than HVCV (44.87% vs. 23.93%, P < 0.0001). There was one case of a new adjacent vertebral fracture in the HVCV group (2%), and 4 cases of new nonadjacent vertebral fractures in the BKP group (7.84%) (P = 0.18). Limitations: A single-center and relatively small-sample size study. Conclusion: HVCV and BKP are safe and effective in improving quality of life and relieving pain. HVCV has a lower cement leakage rate, whereas BKP is more effective in vertebral height restoration. Subsequent fractures are not different between the 2 groups. Key words: Vertebral compression fracture, spine, osteoporosis, cement augmentation, balloon kyphoplasty, vertebroplasty, cement leakage


2021 ◽  
Author(s):  
Hai-Tao Zhu ◽  
De-Gang Ding ◽  
Shui Wang ◽  
Yu-Long Zhu

Abstract Background & Aim: Osteoporotic vertebral compression fractures (OVCFs) are acknowledged as common occurred fractures among humans, especially for the elderly population. The minimally invasive percutaneous methods such as kyphoplasty as well as vertebroplasty have been valid and effective tools in terms of reducing clinical problems, which are associated with more beneficial effects as compared to traditional methods such as open surgery or conservative treatment. Hence, we conducted the current meta-analysis in order to gather updated evidence available for the systematical assessment of the clinical and radiographic outcomes of VP in comparison of KP.Methods: Publications on comparison kyphoplasty versus vertebroplasty in treatment of OVCFs were collected. After rigorous and thorough review of quality, we extracted the data on the basis of eligible trials, which analyzed the summary hazard ratios (HRs) of the endpoints of interested.Results: Totally, our inclusion criteria involved five studies. 561subjects involving 334 patients received VP and 227 patients received KP were included, of which patients receiving KP or VP failed to show any significant differences in the visual analog scale (VAS) scores (MD =-0.02, 95% CI -0.40 – 0.35; P = 0.91),and the risk of cement leakage (OR =1.60, 95% CI 0.82 – 3.12; P = 0.17). Nevertheless, the Oswestry Disability Index (ODI) scores (MD =-1.56, 95% CI -2.39 – -0.73; P = 0.0002), the injected cement volume (MD =-0.40, 95% CI -0.77 – -0.04; P = 0.03) and the operation time (MD =-9.67, 95% CI -11.55 – -7.80; P <0.00001) in VP group were linked to markedly lower trend in comparison of KP group with significant statistical difference.Conclusion: The present meta-analysis controls the acceptable level of the efficacy across the involved trials. The VP had ODI scores, the injected cement volume and the operation time exerted several advantages in this meta-analysis. Yet, VP failed to show benefits in terms of the VAS scores and cement leakage in comparison of KP therapy. Given the combined results of our study, the optimal treatment for patient harboring OVCFs should be determined by further high-quality and multi-center RCTs along with longer follow-ups as well as larger sample size.


BMC Surgery ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Rui Zhong ◽  
Jianheng Liu ◽  
Runsheng Wang ◽  
Yihao Liu ◽  
Binbin Chen ◽  
...  

Abstract Background Vertebral compression fracture is one of the most common complications of osteoporosis. In this study an unilateral curved vertebroplasty device was developed, and the safety, effectiveness, and surgical parameters of curved vertebroplasty (CVP) in the treatment of painful osteoporotic vertebral compression fractures was investigated and compared with traditional bipedicular vertebroplasty (BVP). Methods We investigated 104 vertebral augmentation procedures performed over 36 months. CVP and BVP procedures were compared for baseline clinical variables, pain relief (Visual Analog Scale, VAS), disability improvement (Oswestry Disability Index, ODI), operation time, number of fluoroscopic images, volume of cement per level, and cement leakage rate for each level treated. Complications and refracture incidence were also recorded in the two groups. Results The VAS and ODI in both group had no significant difference preoperative (P > 0.05), and a significant postoperative improvement in the VAS scores and ODI was found in both group (P < 0.001). However, the CVP group had significantly lower operation time, number of fluoroscopic images, and cement leakage rate per level than the BVP group (P < 0.05); however, the volumes of cement per level were similar in the two groups (P > 0.05). Neither group had any serious complications. Five and two patients in the BVP group developed refractures at non-adjacent and adjacent levels, respectively, with one patient developing refractures twice; however, none of the patients in the CVP group developed refractures at any level. Conclusions Our findings revealed that both CVP and BVP were safe and effective treatments for osteoporotic vertebral compression fractures, and CVP entails a shorter operation time, less exposure to fluoroscopy, and lower rate of cement leakage.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3695-3695
Author(s):  
James R. Berenson ◽  
John B Tillman ◽  
Mohamad A. Hussein ◽  
Robert Pflugmacher ◽  
Peter Jarzem ◽  
...  

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.


2021 ◽  
Vol 506 (1-2) ◽  
Author(s):  
Tran Huy Hung ◽  
Nguyen Minh Tien

Background: Percutaneous vertebroplasty (PV) has become an important minimally invasive surgical technique for vertebral compression fractures. However, indications for PV in these cases due to trauma had many rivals and unclearly. These complications, especially cement leakage still common, has many severe consequent. Object and method research: A 60-years-old man, who underwent vertebroplasty in low medical level. He had complete paralised of two leg, urine retention, and severe low back pain. We examined clinical signs, imaging, find and compared with literatures. Case presentation and discussion: We present a case, 60-years-old man, had labor accident, after that he could returned to state of normality. At the second day, he went to local hospital, had diagnosis: compression fractures of L1-L2. He underwent percutaneous vertebroplasty of L1-2 under local anesthesia. Post-operative, he had complete paralised of two leg, urine retention, and severe low back pain. He had exmined again, MRI and took second surgery to removed part of cement leakage. After the second surgery, radiological showed they had complete removed cement leakage, but the patient’s recovery was uneventful and stable. The patient was hospitalized at our instituation after 03 day with complaints of severe low back pain, urine retention and complete paralised of two leg. Conclusion: This is basic technique, widely and rewarding; also has many severe incident, complications. Consequently, we suggest that this technique have to perform in right indications, in the modern medical centre and fully trained surgeon.


2013 ◽  
Vol 5;16 (5;9) ◽  
pp. 447-453
Author(s):  
Huilin Yang

Background: Osteoporotic vertebral compression fractures (VCFs) commonly occur in aged people. Balloon kyphoplasty (KP) has been proven to be efficacious for pain relief and reduction of vertebral height for patients with osteoporotic VCFs. However, very little is known about the comparison of clinical and radiographic outcomes between unilateral and bilateral balloon KP in treating this kind of patients. Objective: To compare the safety and long-term radiographic and clinical outcomes of unilateral or bilateral balloon KP to treat patients with osteoporotic VCFs. Study Design: A systemic review and meta-analysis of all randomized controlled trials (RCTs) comparing the analgesic efficacy, radiographic outcomes, and complications between unilateral and bilateral balloon KP in patients with osteoporotic VCFs. Setting: The MEDLINE, EMBASE, Pubmed, CINAHL databases, Bandolier, and the Cochrane Controlled Trials Register were systematically searched for evidence from their inception to July 2012 by 2 of the authors (J.L. and L.Z.). Methods: Relevant reports were reviewed by 2 assessors independently and the reference lists of retrieved papers were scrutinized to identify further studies for inclusion, using guidelines set by PRISMA statement criteria. Results: Three RCTs were enrolled in this study. The VAS scores showed no statistical difference between the groups before surgery and either at short-term or long-term follow-up. There was no statistical significance in polymethylmethacrylate (PMMA) leakage between the groups. Analysis of 2 studies showed statistical significance in surgery time (WMD -23.77 [-27.83, -19.71]; P < 0.00001) and PMMA (WMD -1.65 [-2.28, -1.02]; P < 0.00001) consumption between the groups. Limitations: There were few data sources from which to extract abstracted data or published studies. There were only 3 RCTs that met criteria enrollment in this meta-analysis. The quality of these trials was quite low (Jadad score: 1-2). Variable reporting of end points and inconsistent definitions meant that we were not able to include every study for each outcome. There was also clinical heterogeneity among the studies. Conclusion: The efficacy of both unilateral and bilateral balloon KP to provide rapid, significant, and sustained pain relief for patients with osteoporotic VCFs is validated. Unilateral balloon KP is a reasonable treatment for patients with osteoporotic VCFs considering that it could achieve equivalent pain relief with less surgery time and PMMA consumption compared to bilateral balloon KP. There was no evidence to prove that unilateral balloon KP results in higher incidence of PMMA leakage than bilateral balloon KP. Although unilateral balloon KP was less efficacious in the reduction of fractured vertebral body, it is still unclear if the clinical results of balloon KP were positively correlated with the restoration of vertebral height and amount. Key words: Kyphoplasty, unilateral approach, bilateral approach, , postoperative pain, osteoporotic fractures


2021 ◽  
Vol 49 (12) ◽  
pp. 030006052110663
Author(s):  
Kai Xu ◽  
Ya-Ling Li ◽  
Song-Hua Xiao

Objective This study was performed to compare the effectiveness and safety of vesselplasty versus vertebroplasty in the treatment of osteoporotic compression fractures with posterior wall rupture. Methods Patients who underwent treatment of a single osteoporotic vertebral compression fracture with posterior wall rupture from January 2016 to February 2020 were retrospectively reviewed. They were divided into a vesselplasty group (n = 17) and a vertebroplasty group (n = 43). Pain relief, radiographic outcomes, and bone cement leakage were compared between the two groups. Results There were no significant differences in the operation time, postoperative pain relief, vertebral compression recovery, or local Cobb angle improvement between the two groups. However, the overall bone cement leakage rate (29.4% vs. 67.4%) and spinal canal leakage rate (0.0% vs. 30.2%) were significantly lower in the vesselplasty group than vertebroplasty group. Conclusions Vesselplasty offers similar pain relief and vertebral compression recovery but lower spinal canal leakage compared with vertebroplasty. Vesselplasty is thus a better option than vertebroplasty for patients with osteoporotic compression fractures with posterior wall rupture.


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