RESUMO
BACKGROUND: The objectification of pain is essential for evaluation, treatment plan and follow-up; therefore, it is necessary to find reliable clinical parameters. OBJECTIVE: The goal of the study was the preoperative screening of a neuropathic component in patients with vertebral compression fracture (WKF), herniated disc (NPP) or spinal cord compression (SKS). MATERIAL AND METHODS: Depending on the preoperative condition on admittance, patients were classified into three groups: group 1 WKF, group 2 NPP and group 3 SKS. To characterize the pain we used the painDETECT questionnaire, the Oswestry questionnaire and further questionnaires. All patients were surgically treated according to the diagnosis, e.g. radiofrequency kyphoplasty, nucleotomy or spondylodesis. RESULTS: We evaluated the data from 139 patients (45% WKF, 34% NPP and 21% SKS). There were no differences in preoperative pain intensity (median ordinal scale 0-10) with a mean preoperative score of 7 for all groups. The total score of the painDETECT questionnaire showed significantly higher results in group 2 (median 18) and in group 3 (median 14) than in group 1 (median 9). There was even a significant difference between groups 2 and 3 (p = 0.03). The highest pain intensity was detected in group 1 with a median visual analog scale (VAS) of 71 mm. The total scores in the painDETECT questionnaire and the scores in the Oswestry questionnaire correlated in groups 2 and 3. CONCLUSION: The painDETECT questionnaire was shown to be a very suitable instrument for evaluating the neuropathic pain component in patients with dorsalgia. This could be very useful in planning further therapy.
Assuntos
Dor nas Costas/diagnóstico , Dor nas Costas/cirurgia , Fraturas por Compressão/diagnóstico , Fraturas por Compressão/cirurgia , Deslocamento do Disco Intervertebral/diagnóstico , Deslocamento do Disco Intervertebral/cirurgia , Programas de Rastreamento , Neuralgia/diagnóstico , Neuralgia/cirurgia , Cuidados Pré-Operatórios , Compressão da Medula Espinal/diagnóstico , Compressão da Medula Espinal/cirurgia , Fraturas da Coluna Vertebral/diagnóstico , Fraturas da Coluna Vertebral/cirurgia , Idoso , Idoso de 80 Anos ou mais , Dor nas Costas/psicologia , Discotomia Percutânea , Feminino , Fraturas por Compressão/psicologia , Humanos , Deslocamento do Disco Intervertebral/psicologia , Cifoplastia , Masculino , Pessoa de Meia-Idade , Neuralgia/psicologia , Medição da Dor/estatística & dados numéricos , Psicometria , Compressão da Medula Espinal/psicologia , Fraturas da Coluna Vertebral/psicologia , Fusão Vertebral , Inquéritos e QuestionáriosRESUMO
Background: The perception of back pain subjective is hard for physicians to measure. For this reason, questionnaires are an important instrument to evaluate the pain 1. The main point of this study was to verify differentiation of pain symptoms in patients with different pain mechanisms. The most important parameter was the PainDetect questionnaire, which can differentiate between nociceptive and neuropathic pain. Additional parameters were measured before and after surgery to characterise pain symptoms in detail. Material and Methods: We selected patients with diagnosed vertebral compression fracture, herniated disc or with spinal cord compression. To characterise the preoperative condition on admittance, we collected the data from the physical examination, as well as clinical data, including X-ray, CT and MRI. To characterise the pain, we used the painDetect questionnaire, the Oswestry Index questionnaire (ODI) and the visual analogue scale (VAS). Depending on the diagnosis, patients were treated by surgery (radiofrequency kyphoplasty, nucleotomy, spondylodesis). At 2 to 3 days and 6 months after surgery, we repeated the questionnaire and compared the results with those before the operation. Data on patient satisfaction and adverse events were also collected. Results: This study included 62 patients with vertebral compression fracture (group 1: VBF, 89â% female, mean age 71 years) and 77 patients with herniated disc or spinal cord compression (group 2: non-VBF, 55â% female, mean age 53 years). There was no difference between both groups in preoperative pain intensity (acute, maximum, average): median ordinal scale 0 to 10; group 1: 6, 8, 7; group 2: 6, 9, 7. The total score in the painDetect questionnaire differed significantly between the two groups (median group 1 = 9, group 2 = 17; effect size r = 0.5; p = 0.000). The existence of neuropathic pain was presumed (> 90â%) in 3â% of the patients in group 1 and in 13â% of patients it was not excluded. In contrast, in group 2 it was presumed (> 90â%) in 43â% of patients and in 30â% of patients it could not be excluded. Patients with vertebral compression fracture had greater pain intensity (VAS 71) than patients from group 2 (VAS 53). There was no difference in the total score of the Oswestry questionnaire between the two groups (56â% vs. 58â%). Pain intensity was significantly reduced in both groups after the operations. Six months postoperatively, pain intensity (median ordinal scale 0 to 10; acute, maximum, average) was 2, 5, 3 in group 1 and 2, 4, 2 in group 2. Moreover, the final scores of the painDetect questionnaires were significantly lower in both groups after the operations (4 in both groups). The median score of the ODI was reduced in both groups, with an effect size of 0.6. 98â% of the patients in group 1 and 94â% in group 2 were satisfied with the outcome of the operation. Conclusion: The preoperative pain characteristics of patients with vertebral compression fracture is different from those of patients with herniated disc or with spinal cord compression. 43â% of patients in group 2 exhibited a neuropathic pain component and in 30â% this could not be excluded. In contrast, in group 1 only 3â% of the patients exhibited a neuropathic pain component. Postoperatively, pain symptoms were significant reduced in both groups, so that the risk of chronic pain was considerably less.
Assuntos
Dor nas Costas/diagnóstico , Neuralgia/diagnóstico , Dor Nociceptiva/diagnóstico , Dor Pós-Operatória/diagnóstico , Doenças da Coluna Vertebral/cirurgia , Inquéritos e Questionários , Idoso , Dor nas Costas/epidemiologia , Feminino , Alemanha/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Neuralgia/epidemiologia , Dor Nociceptiva/epidemiologia , Medição da Dor , Dor Pós-Operatória/epidemiologia , Prevalência , Psicometria , Reprodutibilidade dos Testes , Fatores de Risco , Sensibilidade e Especificidade , Doenças da Coluna Vertebral/diagnóstico , Doenças da Coluna Vertebral/epidemiologiaRESUMO
Background: This study reports one year post-operative monitoring of the efficacy and safety of iFuse Implant System® in patients with sacroiliac joint syndrome. Material and Methods: After 6 months of inadequate conservative treatment, patients with properly proven ISG syndrome were selected for surgery. The iFuse implants had a triangular profile and coating of porous titanium plasma spray and were used in the minimally invasive procedures. The procedure was performed under general anaesthesia and fluoroscopic control. In each case, three implants were placed. Results: 24 patients (22 f; 92â%; 54.9 ± 14 years) participated in the study. The operations were performed in 11 patients (46â%) on the left and in 13 patients (54â%) on the right. The mean operative time was 42.4 minutes (95â% CI: 35.6-49.3). The reduction in pain intensity on the VAS scale was 58 ± 11 mm (68 ± 7â%). The Oswestry score showed a median decrease of 44 percentage points (57â%). After 12 months, 15 patients (63â%) reported that they were taking no more painkillers. Conclusion: The minimally invasive treatment of patients with sacroiliac joint syndrome using the iFuse Implant System leads to significant analgesic effects over the period of one year; it also contributes significantly to improving the functioning of the patient.
Assuntos
Artrite/cirurgia , Dor Lombar/prevenção & controle , Próteses e Implantes , Articulação Sacroilíaca/patologia , Articulação Sacroilíaca/cirurgia , Fusão Vertebral/instrumentação , Artrite/complicações , Artrite/diagnóstico , Feminino , Seguimentos , Humanos , Estudos Longitudinais , Dor Lombar/diagnóstico , Dor Lombar/etiologia , Masculino , Pessoa de Meia-Idade , Implantação de Prótese/métodos , Articulação Sacroilíaca/diagnóstico por imagem , Fusão Vertebral/métodos , Síndrome , Resultado do TratamentoRESUMO
INTRODUCTION: Osteoporotic vertebral fractures are a frequent occurrence in geriatric traumatology. Differences in the achievement of pain reduction and restoration of the height of the vertebral body after balloon kyphoplasty (BKP) or radiofrequency-targeted vertebral augmentation (RF-TVA) were to be tested on a randomized population. METHODS: A total of 80 patients (f = 59; m = 21) with osteoporotic fractures of vertebral bodies were assigned to the groups BKP (n = 44) or RF-TVA (n = 36). The clinical analyses were compared peri- and postoperatively in a prospective study with an additional follow-up examination after 1 year. RESULTS: The operations for BKP were bipedicular in all cases; for RF-TVA, a bipedicular access was required in only five cases (14 %) (p>0.0001). There were confirmed differences with respect to the amount of cement used (ml) between the two groups (BKP = 4.9 ± 1 vs. RFTVA= 3.4 ± 1; p<0.001). In the BKP group, the angle of kyphosis was reduced by an average of 1.65° and in the RF-TVA group by an average of 2.8° by the operation. The analysis of the maximum VAS data showed a clear postoperative reduction in the intensity of pain of approximately 4.5 cm in each of the groups with no discernible difference. After 12 months, the majority of patients in both groups (BKP = 61 % vs. RF-TVA = 83 %) reported being free of pain when at rest without a significant difference(p = 0.05). CONCLUSIONS: 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.
Assuntos
Ablação por Cateter/métodos , Fraturas por Compressão/cirurgia , Cifoplastia/métodos , Fraturas por Osteoporose/cirurgia , Fraturas da Coluna Vertebral/cirurgia , Idoso , Idoso de 80 Anos ou mais , Dor nas Costas/prevenção & controle , Feminino , Fraturas por Compressão/diagnóstico por imagem , Humanos , Masculino , Fraturas por Osteoporose/diagnóstico por imagem , Estudos Prospectivos , Radiografia , Fraturas da Coluna Vertebral/diagnóstico por imagem , Resultado do TratamentoRESUMO
OBJECTIVE: The study objective was assessing patient adherence to a fixed-dose combination (FDC) of bisoprolol and amlodipine in daily practice in patients who had been switched from the free to the fixed-dose combination prior to recruitment. MATERIAL AND METHODS: The non-investigational study was carried out in Poland. Patients over 18 years of age with essential hypertension were recruited if they had already been switched from a free combination to the FDC at least 4 weeks prior to recruitment. Exclusion criteria included pregnancy, lactation, any contraindication to the FDC, and other antihypertensive treatment. Adherence was measured by tablet count (tablets taken divided by tablets prescribed, times 100) and defined as follows: excellent >90%, good 76-90%, moderate 51-75%, bad ≤50%. Other patient data, clinical findings and laboratory values were recorded upon availability at study start, after 3 months (voluntary) and after 6 months. RESULTS: Data of 4288 patients (mean age: 59 years; gender: 50% each) were documented. The average daily doses of the FDC were 5.8 mg bisoprolol and 6.4 mg amlodipine. These doses differ only slightly from those of the free combination. After 3 months' treatment with the FDC, a dose increase was carried out in 113 patients for bisoprolol and in 126 for amlodipine. After 6 months of FDC treatment, 82% of the participants of the study showed excellent adherence and for a further 15% the adherence could be considered good. This strong adherence may have led to the observed reduction in systolic and diastolic blood pressure of 11% (Cohen's D efficient size 1.23). In addition, pulse pressure decreased from 58.8 mm to 52.2 mm. Also in diabetic patients (21% of the cohort), further reduction of systolic blood pressure values could be achieved (mean before 150 mm, after 133), wherein the initial differences compared to patients without diabetes had disappeared. The pulse rate also changed from 75 b/min to 68 b/min under the FDC. CONCLUSION: These study results clearly show that the FDC leads to excellent patient adherence and therefore may result in better blood pressure control. Blood pressure control is crucial in the risk reduction of cardiovascular events. The key limitation of this study is that the study design does not allow a direct comparison of patient adherence under the free and the fixed-dose combination.
Assuntos
Anlodipino/uso terapêutico , Anti-Hipertensivos/uso terapêutico , Bisoprolol/uso terapêutico , Hipertensão/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Anlodipino/administração & dosagem , Anti-Hipertensivos/administração & dosagem , Bisoprolol/administração & dosagem , Pressão Sanguínea/efeitos dos fármacos , Combinação de Medicamentos , Hipertensão Essencial , Feminino , Frequência Cardíaca/efeitos dos fármacos , Humanos , Masculino , Pessoa de Meia-Idade , Polônia , Adulto JovemRESUMO
PURPOSE: 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. METHOD: Based on an extensive literature review on the topic of "vertebral fractures--surgical augmentation techniques" we summarized the results of published clinical trials and experimental testing which address clinically relevant questions. The selection of the publications in reference books and scientific journals covers the time period from the end of the 1970s until the present. RESULTS: The final selection of more than 50 publications with, in the opinion of the authors, clinically relevant data led to the following results, which can be of significance for clinical application. The prerequisites for the success of all augmentation methods include the earliest possible surgical intervention, optimal technical equipment and an experienced, interdisciplinary team, as well as thorough consideration of the situation of the individual patient. The selection of the material for vertebral augmentation depends on the surgical method. The material of choice remains polymethylmethacrylate (PMMA), and the best record of efficacy and safety is displayed by radiofrequency kyphoplasty with ultrahigh-viscosity cement. Regarding clinical efficacy and safety, there are many convincing documentations showing superiority of vertebroplasty and kyphoplasty in comparison with conservative therapeutic regimens. Initial results of clinical studies with additional implants indicate a trend toward further improvement in clinical success and suggest possible broader clinical possibilities of application. CONCLUSION: Modern, minimally invasive augmentation techniques represent a real alternative to conservative treatment of patients with vertebral fractures. Further technical and clinical development in this area should aim at optimizing procedural safety while continuing to achieve comparably good results to current methods. Minimizing damage to the remaining trabecular structures as well as to adjacent vertebral disks and vertebrae should be paramount of importance. SUMMARY: Options for the treatment of vertebral fractures: Reductions in bone density and pathological changes in bone structure are associated with an elevated risk of fractures, which can lead to decisive functional impairment, pain, and a host of further comorbidities. Vertebral augmentation can be considered as an alternative conservative treatment, in order to achieve immediate and lasting pain relief as well as improvement in functional impairment. To achieve greater safety, instrumentation for transpedicular access and incorporation of radiopacifiers in PMMA for vertebroplasty were developed in mid-eighties. Balloon kyphoplasty was introduced in the end nineties, and results of prospective, randomized clinical studies have confirmed the safety and efficacy; the destruction of the remaining native spongiosa structures during balloon expansion is viewed as a disadvantage of this method. The two step method of cavity creation followed by cement delivery known as kyphoplasty has been further refined and developed by and varied by technology/procedural developments. This includes most the radiofrequency kyphoplasty (DFINE Inc., San Jose, CA, USA), in which ultrahigh-viscosity cement is delivered at a controlled delivery rate, following producing a bone sparing size and side specific cavity which minimizes loss of spongiosa, allowing for mechanical stability upon interdigitation of cement into that remaining trabecular bone. This combination has been shown to preserve vertebral structures and reduces the risk of leakages. Finally, systems have been available in which cement augmentation of implants to enhance mechanical stability of the implants or the overall fracture is constructed by load sharing.
Assuntos
Fraturas por Compressão/cirurgia , Fraturas da Coluna Vertebral/cirurgia , Anti-Inflamatórios não Esteroides/uso terapêutico , Cimentos Ósseos/uso terapêutico , Fraturas por Compressão/tratamento farmacológico , Humanos , Cifoplastia/métodos , Polimetil Metacrilato/uso terapêutico , Próteses e Implantes , Fraturas da Coluna Vertebral/tratamento farmacológico , Vertebroplastia/métodosRESUMO
OBJECTIVE: An evaluation of treatment protocols was used to expand the documentation of efficacy and safety of radiofrequency kyphoplasty (RFK). Additionally, a comparison of this new and innovative procedure with conservative treatment was carried out. PATIENTS, MATERIALS AND METHODS: Patients with painful osteoporotic vertebral fractures according to the common findings in an orthopaedic university hospital were included in the comparison study in which the indication for surgical intervention action according to the DVO guidelines was interdisciplinary confirmed. For the comparison group, patients with the same clinical and radiological findings were recruited who rejected a surgical intervention. For surgery, the StabiliT® Vertebral Augmentation System for a radiofrequency kyphoplasty by the company DFine was used. The cement was injected with a "multiplex controller". Thus, the results of the new method were compared to those of a group that was treated conservatively. RESULTS: The radiofrequency kyphoplasty (n = 114) resulted in an average decrease of VAS scores by almost 60 mm, which increased during the follow-up. Similarly, the Oswestry scores showed a marked improvement by 46 % points after 6 weeks. The mean increase in vertebral body height was 2.8 mm after radiofrequency kyphoplasty. In the conservatively treated group only very small changes compared to the initial findings were registered during the 6-week observation period. Accordingly, 33 of 67 patients decided after 6 weeks for surgery, which led to corresponding improvements (VAS, Oswestry, vertebral body height). Noteworthy is the low rate of cement leakage in the radiofrequency kyphoplasty group of 6 % (n = 7). CONCLUSIONS: Radiofrequency kyphoplasty offers a secure superiority over conservative treatment regarding clinical efficacy. In addition, the fractured vertebrae can be better targeted and erected, a longer processing time of the cement is ensured, a high interdigitation of the cement with the bone is guaranteed, the rate of cement leakage is low, the risk of radiation for the surgeon is minimised, and the operation time is shortened.
Assuntos
Ablação por Cateter/estatística & dados numéricos , Fraturas por Compressão/epidemiologia , Fraturas por Compressão/terapia , Cifoplastia/estatística & dados numéricos , Fraturas da Coluna Vertebral/epidemiologia , Fraturas da Coluna Vertebral/terapia , Idoso , Idoso de 80 Anos ou mais , Feminino , Alemanha/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Prospectivos , Resultado do TratamentoRESUMO
BACKGROUND: The anchorage of pedicle screws can be challenging in the osteoporotic spine. A promising technique are cement augumented pedicle screws. The goal of this study was to gain more information regarding application of pedicle screw augmentation in Germany. MATERIALS AND METHODS: Participants of the National German Spine Congress 2009 were invited to participate in an internet-based anonymous survey regarding application of pedicle screw augmentation. The questionnaire was related to different aspects of materials and procedures for pedicle screw augmentation. The frequency of answers was divided according to the specialty state of the surgeons: orthopaedic and trauma surgeons vs. neurosurgeons. The Mantel-Haenszel test was applied to evaluate the differences between the groups. RESULTS AND CONCLUSION: 69 (64 %) orthopaedic and trauma surgeons and 39 (36 %) neurosurgeons participated (n = 108). Nearly 80 % of the participants use cement-augmented pedicle screws in their daily practice. Almost 2/3 of the specialists apply cannulated screws or other special screws. The Expedium (Company) screws are particularly preferred. The insertion of screws is combined with kyphoplasty or vertebroplasty in 20 % of the cases. The balloon kyphoplasty was applied most commonly. There was no statistical difference between the surgeon groups regarding the different techniques. The main indications for pedicle screw augmentation were osteoporosis, intraoperative findings as well as loosening of screws, and revision. The most frequently observed complication is cement extravasation into the spinal canal (28 %). The cost issue is considered as being important but unknown to most of the participants. It can be assumed that the use of pedicle screws in Germany is well established in spine surgery, without as yet a standard technique being established.
Assuntos
Parafusos Ósseos , Polimetil Metacrilato/uso terapêutico , Padrões de Prática Médica/estatística & dados numéricos , Curvaturas da Coluna Vertebral/epidemiologia , Curvaturas da Coluna Vertebral/terapia , Fusão Vertebral/estatística & dados numéricos , Vertebroplastia/estatística & dados numéricos , Cimentos Ósseos/uso terapêutico , Cimentação/estatística & dados numéricos , Terapia Combinada , Coleta de Dados , Alemanha/epidemiologia , Humanos , Fusão Vertebral/instrumentação , Vertebroplastia/métodosRESUMO
BACKGROUND: As a further alternative to previously used vertebral augmentation methods, the Kiva VCF Treatment System® was clinically investigated. MATERIAL AND METHODS: The pilot study included 24 patients (mean age 74 years, 34 vertebrae). RESULTS: During an operation period of 16.6 minutes on average 2.2 ± 1 mL of PMMA cement were injected. 87â% of patients were satisfied or very satisfied with this treatment. In 2 cases leakage of cement has been registered. The pain intensity was already reduced after 7 days to 69.5 mm (VAS scale 0-100). After 30 days, the difference from baseline was 76 mm. Significant improvements have also been shown in the Oswestry Score (functional ability), physical performance and mental well-being. CONCLUSION: On the basis of these results, the new augmentation can be described as being effective in the treatment of painful vertebral fractures.
Assuntos
Cimentos Ósseos/uso terapêutico , Fraturas por Compressão/terapia , Fixadores Internos , Dor/prevenção & controle , Fraturas da Coluna Vertebral/terapia , Vertebroplastia/instrumentação , Idoso , Análise de Falha de Equipamento , Feminino , Fraturas por Compressão/complicações , Humanos , Masculino , Dor/etiologia , Projetos Piloto , Desenho de Prótese , Fraturas da Coluna Vertebral/complicações , Resultado do Tratamento , Vertebroplastia/métodosRESUMO
OBJECTIVE: By evaluations of treatment protocols, the documentation of balloon kyphoplasty regarding efficacy, duration of action and safety should be expanded. In addition, the evaluations should help to clarify the differences in balloon kyphoplasty for patients with vertebral fractures concerning efficacy and safety in relation to the underlying diseases: osteoporosis, bone metastases or myeloma. MATERIAL AND METHODS: In order to reposition the endplates of the vertebrae a balloon was inserted after placement of the working channels. After removal of the balloon, the resulting caverns were filled with PMMA. The radiological and clinical follow-up examinations were carried out over a period of up to 3 years. The clinical and radiological findings before and after treatment at specified visits were transferred to a statistical programme and evaluated. RESULTS: The comparisons of the postoperative results according to the initial diagnosis (metastases: n = 222, osteoporosis: n = 122, myeloma: n = 122) demonstrated significant differences with respect to the cement leakage (14 %, 5 %, 7.5 %), but in all cases without any clinical relevance. The small differences related to the reduction in pain intensity (VAS > 50 mm in each group) after surgery were up to 12 months with no clinical significance. Also in the Oswestry score no differences between the 3 groups were registered. In the case of osteoporosis patients, due to the lower starting position a more significant increase of vertebral body height could be achieved by the kyphoplasty than in the comparison groups of patients with metastases or myeloma (∅ 3.1 mm vs. 0.4-0.5 mm; P < 0.001). Consequently, the kyphosis angle decreased in the osteoporotic group also more strongly than in the comparison groups. CONCLUSIONS: It is evident that the pain relief in the vast majority of cases started immediately after surgery. Additionally, a significant improvement in functioning (Oswestry score) was registered. Both clinical parameters - as far as they could be checked - showed a steady degree of improvement over a period of at least 3 years. This comparative analysis led to the conclusion that balloon kyphoplasty can be successfully applied indiscriminately in patients with vertebral fractures as a result of osteoporosis and also to fractures associated with bone metastases or with myeloma.
Assuntos
Cateterismo/estatística & dados numéricos , Cifoplastia/estatística & dados numéricos , Mieloma Múltiplo/epidemiologia , Mieloma Múltiplo/secundário , Osteoporose/epidemiologia , Fraturas da Coluna Vertebral/epidemiologia , Fraturas da Coluna Vertebral/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Medição de Risco , Fatores de Risco , Resultado do TratamentoRESUMO
PURPOSE: Since the 1990s, balloon kyphoplasty has been proven as an effective method of treating patients with painful vertebral compression fractures (VCF). The radiofrequency kyphoplasty is an innovative procedure available since 2009, for which an ultra-high viscosity cement is used. For the statistical comparison of the two methods of augmentation, the clinical and radiological data of 2 larger patient groups were evaluated. MATERIALS AND METHODS: As part of the surgical treatment of patients with conservative therapy-resistant osteoporotic vertebral fractures, a prospective study of radiofrequency kyphoplasty (RFK) was performed between 2009 and September 2010. The treatment was minimally invasive using the StabiliT® Vertebral Augmentation System by DFine for which the StabiliT® multiplex controller, the articulating VertecoR® Midline Osteotome, and the radiofrequency-sensitive StabiliT® ER2 bone cement were applied. From the clinical aspect, measurement parameters for efficacy and safety were the course of pain intensity using a visual analogue scale (VAS: 0 to 100 mm) and the Oswestry disability score (0-100%). For the radiological outcome the increase in the middle and anterior parts of the treated vertebra and also the reduction of kyphosis after surgery and after 6 months were evaluated. Furthermore, the extent of cement extrusion and the duration of operation time were compared. There were 2 groups of patients chosen with the same indication, and with the same average VAS prior to treatment. For the balloon kyphoplasty (BKP) the Kyphon® technology was used. For the BKP group the same parameters as in the first group were evaluated (matched pairs). To compare the data statistically, parametric and non-parametric tests were applied. RESULTS: For the radiofrequency kyphoplasty group (RFK) 114 patients were recruited, and for the balloon kyphoplasty group (BKP) 114 appropriate patients were selected. In 48% of the RFK patients and in 44% of the BKP patients more than one vertebral body were treated (thoracic or lumbar). Prior to treatment 84 mm on the VAS were calculated in both groups. The decrease in VAS values (RFK vs. BKP) immediately after surgery was 58.8 vs. 54.7 mm (p = 0.02), and 73.0 vs. 58.9 mm after 6 months (p < 0.001). In both groups improvements in the Oswestry scores were registered after 6 months without a statistically significant difference. In both groups, the middle part of the vertebral bodies was increased by an average of 3.1 mm. RFK yielded a decrease in the average kyphosis angle of 4.4, the BKP resulted in about 3.8 degrees. Concerning cement leakage a key difference in favor of the radio frequency kyphoplasty was detected (6.1â% vs. 27.8%; p < 0.0001). For RFK a significant shorter duration of operation time was calculated (28.2 vs. 49.6 min; p < 0.001). CONCLUSIONS: The RFK has proven to be a clinically very effective procedure that does somewhat better than BKP in long-lasting pain relief. No differences could be detected regarding improvement of functioning and the mean restoration of mid- and anterior vertebral height. As far as the safety aspect is concerned the RFK offers the advantage of a statistically significant lower proportion of cement extrusion.