Clinical comparison of postoperative results of balloon kyphoplasty (BKP) versus radiofrequency-targeted vertebral augmentation (RF-TVA): a prospective clinical study

Radmer²,

et al. 2017

Eur Spine J

Purpose The objective of this prospective, randomised study was to examine the feasibility and clinical outcome of balloon sacroplasty and radiofrequency sacroplasty. Methods In 40 patients with a total of 57 sacral fractures, CT-guided cement augmentation was performed by means of BSP or RFS. For BSP, the balloon catheter was inflated and deflated in the fracture zone, and the hollow space, thus, created was then filled with PMMA cement. For RFS, the spongious space in the fracture zone was initially extended using a flexible osteotome, and the highly viscous PMMA cement, activated by radiofrequency, was then inserted into the prepared fracture zone. Pain intensity was determined on a VAS before the intervention, on the second day, and 6, 12 and 18 months after the intervention. The results were tested for significance by means of paired Wilcoxon rank-sum tests and Mann-Whitney U tests. Results BSP and RFS were technically fully feasible in all patients. An average of 6.3 ml cement per fracture was inserted in the BSP group and an average of 6.1 ml per fracture in the RFS group. Leakage could be ruled out for both procedures. The mean pain score on the VAS before the intervention was 8.6 ± 0.55 in the BSP group and 8.8 ± 0.58 in the RFS group. On the second postoperative day, a significant pain reduction was seen (p \ 0.001), with an average value of 2.5 (BSP ± 0.28, RFS ± 0.38) for both groups. After 6 (12; 18) months, these values were stable for the BSP group at 2.3 ± 0.27 (2.3 ± 0.24; 2.0 ± 0.34) and for the RFS group at 2.4 ± 0.34 (2.2 ± 0.26; 2.0 ± 0.31). With regard to pain, exceedance probability values of p = 0.86 (6 months), p = 0.94 (12 months) and p = 1 (18 months) were seen, so that neither treatment method leads to differences in results. Conclusions BSP and RFS are interventional, minimally invasive procedures that enable reliable cement augmentation and achieve equally good clinical outcomes in the medium term.

Section: Discussionmentioning

confidence: 54%

Comparison of the 18-month outcome after the treatment of osteoporotic insufficiency fractures by means of balloon sacroplasty (BSP) and radiofrequency sacroplasty (RFS) in comparison: a prospective randomised study

Radmer²,

et al. 2017

Eur Spine J

“…There were 5 studies from Germany [8,9,24,26,27] and 1 study from USA. [25] The extracted studies included 2 RCTs, [9,24] 1 prospective cohort studies, [26] and 3 retrospective cohort studies. [8,25,27] Five studies were published in English while 1 was in German.…”

Section: Resultsmentioning

confidence: 99%

“…Two RCT studies [9,24] reported adequate randomization, but the allocation concealment and blinding during study were unclear, and the outcomes were not reported satisfactorily enough. The rest 4 studies [8,25–27] were not RCTs, and the randomization, concealment, blind, and outcome were of high risk of bias.…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Comparison of radiofrequency kyphoplasty (RFK) and balloon kyphoplasty (BKP) in the treatment of vertebral compression fractures

Feng

Shen²,

Feng³

et al. 2017

Medicine

Background:Balloon kyphoplasty (BKP) is a widely adopted minimally invasive treatment for vertebral compression fractures (VCFs), but leakage of cement is a main complication of BKP. A novel vertebral augmentation technique radiofrequency kyphoplasty (RFK) with high viscosity cement was developed in 2009. Here, we aim to evaluate whether RFK can relieve symptoms efficiently and reduce cement leakage.Methods:A literature search was performed using Pubmed, Embase, and Cochrane CENTRAL until September 30, 2016. Both randomized controlled trial (RCT) and non-RCT studies comparing RFK and BKP were included. The main outcomes included pain relief (VAS), functionality improvement (ODI), operation time, reduction of deformity (vertebral height and kyphosis angle), and incidence of cement leakage. The origin of heterogeneity was further explored by subgroup stratification.Results:A total of 6 studies involving 833 patients with VCFs were included. The reduction of VAS score in the RFK group was 3.96 points more than that in the BKP group (P = .0007) postoperatively, and the improvement persisted until 12 months after the surgery (P < .00001). The operation time was shorter in RFK group than that in BKP group (P = .01). The increase of anterior vertebral height shortly after the operation was 0.53 mm greater in RFK group (P = .01). The decrease of kyphotic angle after RFK was 0.63° and 0.92° greater than that after BKP, both immediately and 6 months after operation (P = .002 and P < .00001, respectively). There was no significant difference between the incidence of cement leakage after RFK and BKP (P = .06). Further subgroup analysis stratified by study design indicated that the incidence of leakage decreased 15% in RFK than BPK (P < .00001) in non-RCT subgroup, but RFK and BKP treatments were equivalent in the RCT studies (P = .86).Conclusion:RFK appears to be more effective and safer than BKP in the present meta-analysis. The incidence of cement leakage diverges in RCT and non-RCT studies, so large-sample multicentered RCT studies are required to validate this new surgery system.

“…Osteoporotic vertebral fractures are a leading cause of disability among the elderly population. Their incidence in Europe has been estimated to be approximately 500.000 fractures per year rendering treatment options of particular importance [1][2][3][4] . While conservative management remains the mainstay of treatment, minimally invasive techniques such as kyphoplasty (KF) and vertebroplasty (VP) offer valuable alternatives, especially in cases of lasting pain.…”

Section: Introductionmentioning

confidence: 99%

Radiofrequency kyphoplasty for the treatment of osteoporotic vertebral fractures: A review of the literature

Pernientakis¹,

Masouros²,

Margiannis³

et al. 2018

JRPMS

Vertebral fractures are a leading cause of disability among the elderly people. While conservative treatment remains the mainstay of treatment, other techniques such as kyphoplasty are reserved for cases of lasting pain. However, cement extravasation has traditionally been a relatively common complication of all vertebra augmentation procedures. Radiofrequency kyphoplasty (RF-VTA) is a relatively new method, which relies on the targeted creation of minimally destructive paths, thus preserving the microarchitecture of the trabeculae. In addition, it yields comparable or superior outcomes than compatible techniques. The aim of this project is to review all the studies concerning this novel technique and provide the reader with its results and potential adverse effects.