Evidence about the DFine StabiliT | Which Medical Device

PURPOSE:
Traditional balloon kyphoplasty (BK) is a common treatment for symptomatic vertebral compression fractures. The purpose of this study was to compare a novel vertebral augmentation technique, radiofrequency-targeted vertebral augmentation (RF-TVA), to BK for restoration of vertebral height, cavity creation, and polymethylmethacrylate (PMMA) delivery and interdigitation into the surrounding trabeculae.

METHODS:
This ex vivo biomechanical pilot study utilized 16 osteoporotic cadaveric vertebral bodies in a standardized fracture model to compare unipedicular RF-TVA (n = 8) to bipedicular BK (n = 8). Four specimens from each group were tested in loaded and unloaded conditions. All specimens were imaged, assessed for height restoration, and sectioned to observe PMMA distribution. A subset of specimens underwent computed tomography scanning to assess cavity creation and trabecular architecture prior to cement delivery.

RESULTS:
Anterior height restoration was greater with RF-TVA (median: 84%, interquartile range: 62%-95%) compared to BK (median: 69%, interquartile range: 60%-81%), although the difference did not achieve statistical significance (P = 0.16). Anterior height restoration was numerically greater under loaded (median: 70% versus 66%) and unloaded (median: 94% versus 77%) conditions with RF-TVA versus BK. RF-TVA produced more discrete cavities and less native trabecular destruction compared to marked trabecular destruction observed with BK. RF-TVA consistently showed a well-identified focal area of PMMA with an extensive peripheral zone of PMMA interdigitation, providing mechanical interlock into the adjacent intact trabecular matrix. In contrast, BK yielded little evidence of PMMA interdigitation beyond the boundaries created by the balloon tamp due to the crushed trabecular bone peripherally.

CONCLUSION:
RF-TVA achieves favorable vertebral height restoration with targeted PMMA delivery and less trabecular destruction compared to BK. RF-TVA has potential clinical utility in the aging population with painful osteoporotic vertebral fracture.

Credits: Clin Interv Aging. 2012;7:525-31.

BACKGROUND:
Both vertebroplasty and balloon kyphoplasty have been described for treatment of vertebral compression fractures. Vertebroplasty is known for its high leakage rate compared with balloon kyphoplasty. In vitro studies have shown that high-viscosity cements significantly decrease the incidence of cement leakage and increase the predictability of cement fill in cancellous bonelike substrates compared with low-viscosity cements.

OBJECTIVE:
This study compares the incidence and pattern of cement leakage in cases treated with standard balloon kyphoplasty (BKP) and a novel vertebral augmentation procedure, radiofrequency targeted vertebral augmentation (RF-TVA).

STUDY DESIGN:
Retrospective evaluation of postoperative radiographs.

SETTING:
Single center inpatient and outpatient population.

METHODS:
Two methods of vertebral augmentation were utilized. Conventional bipedicular BKP and RF-TVA, a novel unipedicular technique which uses a navigational osteotome to create targeted, bone sparing cavities and RF energy to deliver an ultra-high viscosity cement at a consistent rate via a remote controlled, automated hydraulic delivery system. Postoperative radiographs of patients treated with the 2 techniques were critically analyzed for the incidence and location of cement leakage. Eighty consecutive patients with 106 treated levels were included. Thirty-five patients with 49 levels in the BKP and 45 patients with 57 levels in RF-TVA group were evaluated.

RESULTS:
Leakages less than 1-2 mm were not reported since they may not represent any clinical significance. In the BKP group, 6 leakages (12%) were reported (3 discal, 2 venous, one paravaertebral, and no epidural). In the RF-TVA group, a total of 3 leakages (5%) were reported, (one discal, 2 venous, no paravaertebral or epidural). Using contingency analysis for leakage per level, there was a statistical difference for leakage between RF-TVA and standard BKP, P < 0.01.

LIMITATIONS:
Retrospective study, single center.

CONCLUSIONS:
The RF-TVA technique may provide an approximately 50% reduction in leakage rate when compared to standard BKP. This may be related to the combination of controlled delivery of radiofrequency activated (high viscosity) cement at a fixed, low rate of delivery into site-specific channels created using a navigational osteotome. Additionally, based on the unipedicular access and remotely controlled cement delivery RF-TVA may decrease procedural invasiveness and physician radiation exposure, respectively.

Credits: Pain Physician. 2013 Sep-Oct;16(5):E513-8.

Vertebral augmentation procedures are widely used to treat osteoporotic vertebral compression fractures (VCFs). We report our initial experience with radiofrequency-targeted vertebral augmentation (RF-TVA) in 20 patients aged 50 to 90 years with single-level, symptomatic osteoporotic VCF between T10 and L5, back pain severity >?4 on a 0 to 10 scale, Oswestry Disability Index ??21%, 20% to 90% vertebral height loss compared to adjacent vertebral body, and fracture age <?6 months. After treatment, patients were followed through hospital discharge and returned for visits after 1 week, 1 month, and 3 months. Back pain severity improved 66% (P < 0.001), from 7.9 (95% CI: 7.1 to 8.6) at pretreatment to 2.7 (95% CI: 1.5 to 4.0) at 3 months. Back function improved 46% (P < 0.001), from 74 (95% CI: 69% to 79%) at pretreatment to 40 (95% CI: 33% to 47%) at 3 months. The percentage of patients regularly consuming pain medication was 70% at pretreatment and only 21% at 3 months. No adverse events related to the device or procedure were reported. RF-TVA reduces back pain severity, improves back function, and reduces pain medication requirements with no observed complications in patients with osteoporotic VCF.

Credits: J Osteoporos. 2013;2013:791397.

A total of 192 patients (116 females; 51 - 90 y) with VCF (n=303) at one to three, levels were treated with RF-TVA or BK. Functionality (ODI), pain (VAS), vertebral, height (anterior, middle) and kyphotic angle were evaluated over a two year period, (postoperatively, 3-4 d, 3, 6, 12 and 24 mo). Additionally, operating time and, occurrence of cement leakage were recorded. RF-TVA is a safe and effective procedure for the treatment of vertebral compression, fractures when compared to BK. Improvement in pain and functional scores following, RF-TVA are durable through 24 months post-procedure and remained better than, those following BK at long term follow up. Operating time for RF-TVA is shorter and the, risk of cement leakage is lower. Both procedures provided similar results in vertebral, height restoration and reduction in kyphotic angle.

Credits: J Spinal Disord Tech. 2013 Nov 15. [Epub ahead of print]

For more than 30 years, minimally invasive surgical procedures have been available to stabilize the fractured vertebrae by cement augmentation leading to significant pain relief, a distinct improvement in quality of life and decreased mortality for patients suffering from osteoporotic vertebral compression fractures. This overview article is designed to provide information on the wide range of augmentation methods previously tested and clinically applied in surgery in an attempt to compile the clinically relevant information on safety and efficacy in the published literature.

Credits: Eur J Orthop Surg Traumatol. 2014 Jul;24 Suppl 1:S131-43. doi: 10.1007/s00590

A certain superiority of RF-TVA with respect to pain relief, amount of cement required, savings of operating time and personnel, and greater safety with respect to cement leakage noted in this study are consistent with other published literature. The differences between the two methods in the frequency of subsequent postoperative fractures and the secondary loss of high restoration were encouraging regarding RF-TVA.

Credits: Eur J Orthop Surg Traumatol. 2015 Oct 19.