[Modified percutaneous achillotentomy according to Hoke for minimally invasive treatment of pointed foot]. / Modifizierte perkutane Achillotenotomie nach Hoke zur minimal-invasiven Spitzfußbehandlung.

OBJECTIVE: Various underlying diseases can lead to a pointed foot in children and adults. If the gastrocnemius and soleus muscles are structurally shortened, various surgical procedures are available to correct this malposition. A preferred method for restoring a normal dorsiflexion of the upper ankle joint is percutaneous achillotentomy according to Hoke. Consideration of the physiological-anatomical torsion of the Achilles tendon as it corresponds to the White technique and is recommended by some authors shows in our experience no advantages. In the present work, we show a modified, likewise minimally invasive form of this surgical method with which immediate full weight-bearing of the affected lower extremity is possible from postoperative day 1. INDICATIONS: All clinically relevant structural pointed foot, for primary and/or for revision treatment. CONTRAINDICATIONS: Infection in the area of the operation. SURGICAL TECHNIQUE: No tourniquet, 3 incisions with the 15 mm knife: (1) medial distal at the transition from the Achilles tendon to the calcaneus, (2) medial proximal approximately 7 cm proximal to the 1st stab incision, (3) lateral, midway between the first two incisions; no skin suturing, application of a lower leg cast. POSTOPERATIVE MANAGEMENT: On postoperative day 1, cast hybridization using Scotchcast (3M Deutschland GmbH, Neuss, Germany), followed by pain-adapted full weight-bearing; removal of the cast in the outpatient department after 4 weeks. RESULTS: A total of 104 patients underwent surgery, 1 case of a local pressure point, no infections, no overcorrections, no Achilles tendon ruptures, in one case a postoperative relapse due to a broken cast. The risk of overcorrection to the foot, which was considered the main complication in the literature, did not occur in any of the cases.

Balloon-assisted sacroplasty as a successful procedure for osteoporotic sacral insufficiency fractures after failure of the conservative treatment.

Osteoporotic vertebral fractures without prior adequate traumatization are frequent diagnosed in orthopedics because of the increasing life expectancy and incidence of osteoporosis. The associated high mortality is caused by reduced mobilization which leads to a higher risk of infection and a bedridden state. On the other hand the diagnosis of sacral insufficiency fractures is often prolonged because of unspecific symptoms while being associated with similar risks. This article presents an overview of the present scientific literature and a retrospective analysis of patients treated via balloon-assisted sacroplasty. In 8 years, ten patients (three men and seven women) were treated. The average age was 78.4 years and the average time until the diagnosis 4.6 weeks. In most patients a significant pain reduction after the failure of conservative treatment thanks to operative treatment as well as increased mobility was observed. Only one experienced a minor surgical complication being cement leakage with nerval impaction which did not compromise her clinical outcome or satisfaction with the procedure. Balloon-assisted sacroplasty can possibly be seen as an effective symptomatic therapy in osteoporotic insufficiency fractures.

Comparison of radiofrequency kyphoplasty and balloon kyphoplasty in combination with posterior fixation for the treatment of vertebral fractures.

BACKGROUND: In case of complex vertebral fractures, posterior fixation is often required for correction of deformity and instability. Fixation is commonly supported by balloon kyphoplasty (BKP) anterior. A development of BKP is radiofrequency-targeted vertebral augmentation (RF-TVA), which leads to comparable results for augmentation and pain relief. OBJECTIVE: This prospective study evaluates the outcome of posterior fixation combined with RF-TVA or BKP, respectively. METHODS: VAS, ODI, kyphosis angle and vertebral height of 44 patients were evaluated preoperatively, 3 and 12 months postoperatively. RESULTS: Both treatments improved vertebral height and kyphosis angle. At 12 months, vertebral height restoration was still significantly better in the BKP group (p < 0.001) and the improvement of kyphosis angle was comparable between both groups (p = 0.71). VAS and ODI improvements were significantly better in the RF-TVA group (p < 0.001). 8% of BKP patients had cement extravasations, compared to 10.5% in the RF-TVA group (p = 1.0). CONCLUSIONS: Combining posterior fixation with RF-TVA leads to better results of VAS and ODI, whereas the vertebral height restoration was favorable for patients treated with BKP. Cement leakage was comparable between both groups. It was asymptomatic and within reported ranges. Limitations of this study are the patient number and different stabilization instrumentation.

Long-term outcome of total hip arthroplasty in patients with haemophilia.

INTRODUCTION: Besides the target joints (elbow, knee and ankle), the hip is one of the commonly affected joints in haemophilic arthropathy. Hip arthroplasty is the therapy of choice after failure of conservative treatment. There are only limited data on long-term results after primary total hip arthroplasty (THA). AIM: The aim of this retrospective study was to analyse clinical outcome and complication rate after total hip replacement in patients with severe haemophilic arthropathy. METHODS: Forty-three patients with haemophilia (PWH), one patient with von Willebrand disease and one patient with a Factor-VII-deficiency undergoing 49 total hip arthroplasties, were evaluated in a retrospective study. Harris hip score (HHS), range of motion (ROM), pain status (visual analogue scale, VAS) complication rate and patient satisfaction were assessed at a mean follow-up of 11.5 years (range: 3-32). RESULTS: HSS, ROM and VAS improved significantly combined with high patient satisfaction. In total, three (6.1%) periprosthetic infections and five (10.2%) aseptic implant loosenings occurred after THA leading to revision arthroplasty. In two (4.1%) cases, a pseudotumour and one (2.0%) periarticular ossification had to be resected after THA. CONCLUSION: Total hip replacement in PWH leads to a significant increase of function, reduction of pain and a high satisfaction. Due to the relatively high complication rate (infections and aseptic loosening) compared to patients without haemophilia, an individual assessment of the risk-benefit ratio from surgical and haemostaseological point of view is needed.

[Preoperative, neuropathic component in patients with back pain]. / Präoperative, neuropathische Komponente bei Rückenschmerzen.

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.

Diagnosis of Neuropathic Components in Patients with Back Pain Before and After Surgery.

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, 89 % female, mean age 71 years) and 77 patients with herniated disc or spinal cord compression (group 2: non-VBF, 55 % 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 (> 90 %) in 3 % of the patients in group 1 and in 13 % of patients it was not excluded. In contrast, in group 2 it was presumed (> 90 %) in 43 % of patients and in 30 % 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 (56 % vs. 58 %). 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. 98 % of the patients in group 1 and 94 % 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. 43 % of patients in group 2 exhibited a neuropathic pain component and in 30 % this could not be excluded. In contrast, in group 1 only 3 % 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.

The QuickLine IL-6 lateral flow immunoassay improves the rapid intraoperative diagnosis of suspected periprosthetic joint infections.

BACKGROUND: When deciding upon the best treatment strategy in revision arthroplasty, it is absolutely crucial to use the best possible preoperative detection whether a periprosthetic joint infection (PJI) is present or not. New molecular markers investigated in serum samples and synovial fluid can help to improve the preoperative diagnosis. In 2001, a novel IL-6 lateral flow immunoassay testing device was introduced which has never been tested in synovial fluid so far. OBJECTIVE: For our study we investigated whether the test can be used safely, feasibly and time effectively with synovial fluid gathered from potentially infected THAs or TKAs and whether the already published cutoff for IL-6 in synovial fluid predicting a PJI can be reproduced using the QuickLine IL-6 immunoassay. METHODS: After ethic approval and within the scope of a prospective controlled trial we investigated 26 patients (m = 9, 34.6%; f= 17, 65.4%) with n = 13 (50%) potentially infected total hip arthroplasties (THAs) and n = 13 (50%) suspected PJIs of total knee arthroplasties (TKAs). Sterile aspirated synovial fluid was examined for total leukocyte count and cell differentiation by a blood count analyzer in body fluid mode as well as for IL-6 (Immulite, Siemens Medical Solutions Diagnostics GmbH, Eschborn, Germany). Another part of the joint aspirate was tested using the QuickLine IL-6 Test by Milenia Biotec (Milenia Biotec, Gießen, Germany). RESULTS: The mean concentration of IL-6 as determined from our reference laboratory testing (Siemens Immulight) for aseptic cases was 1,219 pg/mL (SD 1,369 pg/mL, min 134 pg/mL-max 4,214 pg/mL). The mean IL-6 concentration measured via the IL-6 QuickLine for aseptic cases was 410 pg/mL (SD 371 pg/mL, min 100 pg/mL-max 1562 pg/mL). The test showed no false negative or false positive results in the cases tested. In six patients, PJI was considered proven. The QuickLine Test indicated IL 6 concentrations > 10,000 pg/mL in these cases without further quantification above this maximum detection threshold. Results from the QuickLine Test and the laboratory tests were matched and a non-linear best fit curve (log-log-curve) was applied. The subsequent Spearman correlation showed a correlation coefficient of r = 0.92 (95% CI 0.81-0.97) which corresponds to a two-tailed p-value of < 0.0001, respectively. As a primary finding we were able to show that the Milenia QuickLine IL-6 Test can be used safely, feasibly and time effectively with synovial fluid gathered intraoperatively from potentially infected THAs or TKAs. The test as provided worked well in 84.6% of the samples tested and failed only due to very viscous synovial fluid. As a secondary result we found that the previously published cut-off for IL-6 in synovial fluid predicting a PJI with a sensitivity of 46.88% and a specificity of 97.62% can be reproduced using the QuickLine IL-6 immunoassay. CONCLUSION: Taking the limitations of the low sample size as a given this relatively simple point of care (POC) assay showed promising results in our pilot trial and may help diagnosing PJI. It may help physicians and surgeons to choose the best and least invasive treatment strategy for patients presenting with painful arthroplasty.

[Clinical Trial to Test the iFuse Implant System® in Patients with Sacroiliac Joint Syndrome: One Year Results]. / Klinische Studie zur Prüfung des iFuse Implant Systems® bei Patienten mit Iliosakralgelenksyndrom: 1-Jahres-Ergebnisse.

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; 92 %; 54.9 ± 14 years) participated in the study. The operations were performed in 11 patients (46 %) on the left and in 13 patients (54 %) on the right. The mean operative time was 42.4 minutes (95 % CI: 35.6-49.3). The reduction in pain intensity on the VAS scale was 58 ± 11 mm (68 ± 7 %). The Oswestry score showed a median decrease of 44 percentage points (57 %). After 12 months, 15 patients (63 %) 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.

Radiofrequency Ablation: Temperature Distribution in Adjacent Tissues.

PURPOSE: This clinical study investigates the use of a radiofrequency ablation system specifically developed for the ablation of spinal metastases. The investigation examines possible temperature-associated risks for the adjacent tissues. MATERIAL AND METHODS: A tumour model was simulated for 8 lumbar and 8 thoracic vertebrae of a human cadaveric spine. The tumour mass was ablated with the SpineSTAR electrode (SpineSTAR, DFINE Inc., CA), which has been specifically developed for the ablation of spinal metastases. During the ablation procedure, the temperatures of the vertebra, the epidural space, and the neural foramen were measured with thermocouples. These temperatures were documented as means with standard deviations. Possible differences between lumbar and thoracic vertebrae were analysed with the Mann-Whitney U test. RESULTS: The maximal temperature of the lumbar vertebrae was 46.4 ± 3.3 °C near to the ablation zone, the temperature of the neural foramen was 37.0 ± 0 °C, and the temperature of the epidural space was 37.3 ± 0.7 °C. In the thoracic vertebrae, the temperature was 44.4 ± 1.7 °C near to the ablation zone, 7.9 ± 1.7 °C in the neural foramen, and 37.25 ± 0.7 °C in the epidural space. There was no significant difference in temperature distribution between treated lumbar and thoracic vertebrae. CONCLUSION: Ablation of spinal metastases in a cadaveric model using the SpineSTAR electrode was shown to be a safe method with respect to possible temperature-related risks for the adjacent tissues.

[Palliative approach in outpatient care in Westphalia-Lippe--Follow-up study five years after inception of a structured home-based palliative care system]. / Ambulante Palliativversorgung in Westfalen-Lippe--Eine Follow-up-Erhebung fünf Jahre nach Einführung einer strukturierten Versorgung im häuslichen Umfeld.

INTRODUCTION: Since 2009, based on an agreement to implement palliative care for terminally ill patients at home in Westfalia-Lippe, family doctors and palliative doctors cooperate, supported by coordinators. METHOD: Since 2009, this cooperation is evaluated, concerning supply structure, number of patients and their places of death. RESULTS: In Westfalia-Lippe, yearly approx. 91.000 patients die, approx. 19 % of them, 17.699 patients, were included in palliative care structures, compared to some 6 % in 2009/2010. Whereas in the first years about 70 % of the palliative patients died at home, 2014 this number increased to 75 %. Only 9 % of our patients 2014 died in a hospital (normal ward) - compared to about 13 % in 2009/2010. This applies both for urban and rural areas. CONCLUSIONS: The idea of home based, family doctor supported palliative care led to a significant strengthening of the general out-patient palliative care. The number of patients, integrated in our structures of palliative care in 2014 tripled compare to those of 2009/2010. Well trained and experienced coordinators are the essential guarantee of multidisciplinary and multiprofessional team-work. The results of the regional palliative care structures are different also after the agreement came in effect. Data for quality assurance should be periodically collected and evaluated in the future to develop the palliative care structures for outpatients.

[Diagnosis and Treatment of Spondylodiscitis/Spondylitis in Clinical Practice]. / Diagnose und Behandlung der Spondylitis/Spondylodiszitis in der Klinikroutine.

BACKGROUND: The clinical presentation of spondylsodiscitis/spondylitis are manifold. This commonly leads to a period of several months from initial symptoms to final diagnosis. A standardised treatment is difficult. The purpose of this study is to investigate the treatment carried out for patients with spondylodiscitis or spondylitis to develop an individualised standard care for better treatment. PATIENTS AND METHODS: Data of 90 patients were retrospective analysed. In particular documented data of the initial examination and the following treatments concerning identification of causes and systematically control of pathogens were examined. RESULTS: In 91 % of patients a diagnostically conclusive MRI was conducted. The degree of spondylidiscitis/spondylitis was mainly ASA criteria I or II (86 %). In 96 % of patients different diagnostic methods for identification of pathogens were conducted and documented. RESULTS confirmed the most common pathogens mentioned in the literature. 75 % of patients were treated by surgery. In 93 % of patients an antibiotic treatment was documented. 50 patients (81 %) were successfully healed. CONCLUSION: It is important to identify and treat spondylodiscitis/spondylitis as early as possible. Diagnosis by means of blood culture and MRI and treatment of the infection with antibiotics and possibly surgical interventions seem be very suitable, but need to be individualised to each and every patient.

[A Comparison of Dorsal Decompression and Dorsal Decompression Combined with the Dynamic Stabilisation Device LimiFlex™]. / Vergleich dorsaler Dekompression nicht stabilisiert und dynamisch stabilisiert mit LimiFlex™.

BACKGROUND: Lumbar spinal canal stenosis is commonly treated by dorsal decompression. However, resection of posterior elements increases the biomechanical instability and may lead to further complications. In order to prevent this, fusion of the involved segments is often performed. But further complications may be associated with this, for example, highly reduced flexibility. In order to overcome fusion-related problems, dynamic stabilisation devices, like the new LimiFlex™ Paraspinous Tension Band (PSB), have been developed. This prospective study compares dorsal decompression without stabilisation and dorsal decompression with stabilisation using the PSB in patients with lumbar canal stenosis. METHODS: Sixty-three patients with stenosis involving one or two lumbar vertebral levels were treated with dorsal decompression. Forty received the PSB following decompression surgery. Back, hip and leg pain as well as patient's degree of disability were assessed preoperatively and at 3, 6 and 12 months postoperatively for all patients. Evaluations were conducted using the visual analogue scale (VAS) and the Oswestry disability index (ODI). Adverse events during the study period were evaluated. RESULTS: Patients who received the PSB experienced a better pain relief and improvement in disability compared to patients who received treatment through decompression only. A significant difference of VAS and ODI development was found between both groups when treating two vertebral levels. Furthermore, the total number of adverse events was lower in the PSB group compared to the decompression group. CONCLUSION: Dynamic stabilisation using the PSB delivers better results in terms of VAS and ODI values when compared to only dorsal decompression. In addition, it is also associated with a lower number of complications. The PSB is most favourable when 2 levels are treated.

[Clinical aspects of the problem of vertebral metastases, possibilities of modern treatment methods, considering especially radiofrequency ablation]. / Klinische Aspekte zur Problematik der Wirbelkörpermetastasen, Möglichkeiten moderner Behandlungsmethoden unter besonderer Berücksichtigung der Radiofrequenzablation.

From 100,000 people in Germany, statistically calculated, 441 males and 350 females suffer from a cancer disease. In about 50 to 80 % of patients with breast or prostate carcinoma bone metastases are registered, which is connected, among others, with a high risk for pathological fractures and other debilitating diseases. The diagnosis of bone metastases is done by conventional X-ray equipment, CT, MRI, and especially with the help of skeletal scintigraphy. For therapy bisphosphonates, anti-hormones and chemotherapeutic agents as drugs are used. Furthermore, radiotherapy, radionuclides, surgery and ablative procedures are applied. A more recent technical method is the STAR™ Tumour Ablation System (RFA), by which minimally invasively an electrode is introduced into the vertebral bodies. The system ensures precise control and thus a targeted ablation of the metastases. Several publications and reports describing a combined application demonstrate the synergistic effectiveness of RFA and radiofrequency kyphoplasty.

Treatment options for vertebral fractures an overview of different philosophies and techniques for vertebral augmentation.

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.

[Radiofrequency kyphoplasty combined with posterior fixation in the treatment of burst fractures]. / Radiofrequenzkyphoplastie in Kombination mit posteriorer Fixierung zur Behandlung von Wirbelsäulenfrakturen.

PURPOSE: Radiofrequency kyphoplasty is an advancement of the balloon kyphoplasty and offers comparable results with a shorter operation time and a lower risk of cement leakage. This prospective study investigates the outcome of radiofrequency kyphoplasty in combination with posterior fixation by a cement-augmented screw system. Accordingly, statistical analyses of the treatment data were performed. MATERIALS AND METHODS: 19 patients (mean age: 74.5 ± 7.2 years) with osteoporotic vertebral burst fractures were included in the study. All of them required a surgical intervention for treating the fracture. Thereby, the vertebrae were augmented by radiofrequency kyphoplasty and a posterior fixation by cement-augmentable screws was performed. To evaluate the effectiveness and safety of the procedure, pain was measured with the visual analog scale (VAS) and functional impairment was analysed by measuring the Oswestry disability index (ODI). Furthermore, a radiographic analysis of the anterior and medial height of the vertebrae and the degree of kyphosis were undertaken. All data were recorded preoperatively, 3 to 4 days postoperatively, 3 months postoperatively and 6 months postoperatively and any additionally occurring cement leakage was documented. RESULTS: The treatment showed a significant reduction of pain and improvement of the functional impairment at the 3 to 4 days postoperative evaluation (pVAS < 0.001, pODI < 0.001). The further follow-ups demonstrated an ongoing improvement of the VAS and ODI from each measurement to the next (pVAS_post-3 M < 0.001, pVAS_3 M-6 M = 0.17, pODI_post-3 M < 0.001, pODI_3 M-6 M = 0.004). The height of the vertebrae was significantly improved after the surgery (p_anterior < 0.001, p_medial < 0.001) and reduced slightly from follow-up to follow-up, but still remained higher than the preoperative value. The degree of kyphosis was also significantly improved after the surgery (p < 0.001), whereby a significant deterioration was shown at the following examinations (p_post-3 M = 0.023, p_3 M-6 M = 0.016). But even as the height decreased the degree of kyphosis was still improved in relation to the preoperative values. During the surgery cement leakage occurred in 3 cases (15.79 %). CONCLUSION: Radiofrequency kyphoplasty is a safe and effective procedure for the treatment of vertebral compression fractures in combination with the use of posterior fixation by cement-augmentable screws with an acceptable rate of cement leakage.

[Allergies and school - what makes me itch? A primary school project in Bielefeld on health promotion for allergic diseases]. / Allergie und Schule - Was juckt mich das?Ein Grundschulprojekt in Bielefeld zur Gesundheitsförderung bei allergischen Krankheiten.

INTRODUCTION: According to KiGGS the 12-month prevalence of asthma, hay fever and atopic dermatitis for 7-10-year-old children amounts to 16.7%. Primary school children are not at home with their disease, in everyday school life many detrimental and stigmatising aspects can be observed. In an interdisciplinary primary school project in Bielefeld between 2008 and 2010 the prevalence, disease knowledge and health attitudes of children in the 3rd school year were recorded; an appropriate approach to these diseases was also to be provided. METHODS: In classes of the 3rd school year a 2-hour teaching unit on allergic diseases was carried out. Before and after (1st + 2nd examination time points [ETP]) the children were questioned about their knowledge and attitudes to allergic diseases and their general opinions about health. The parents were similarly questioned. RESULTS: In 2008, 23 schools with 64 classes and 1 345 children participated in the project, the average age of the children was 8.9 years. Data were obtained for 1 216/1 211 children at the 1st and 2nd ETPs, respectively. 336 (27.6%)/367 (30.3%) stated that they had an allergic disease, of these 16.6%/17.3% had an allergy, 5.1%/5.9% asthma and 4.0%/6.6% atopic dermatitis (the parents reported 15.1%, 5.4% and 7.8%). Clear deficits were found in disease knowledge but could be markedly improved. CONCLUSIONS: In comparison to KiGGS data published in 2007, our prevalence rates for allergies are higher - albeit with a wider definition of allergy; the numbers for asthma and atopic dermatitis are comparable. The knowledge deficits among children indicate the necessity for further information. The project was continued in 2011 and should be implemented in the primary school teaching programme.

[Revenue and losses with vertebral augmentation under the G-DRG system 2012 - a comparison of supply costs in the context of vertebroplasty and kyphoplasty]. / Ertrag und Verlust bei vertebralen Augmentationen im G-DRG-System 2012 - Ein Vergleich des Versorgungsaufwands bei Vertebroplastie und Kyphoplastie.

BACKGROUND: If clearly indicated and implemented, augmentations of vertebral bodies with cement are standardized, safe and low-risk procedures. However, the multiplicity of providers and systems are today more varied than ever. At present, the systems differ starkly from one another not only in specifications, possible applications and extensions of indications, but they are also extremely variable in price. Publications have shown that in times of medical-economic change, vertebral augmentations make sense not only medically, but also in terms of economics and the national economy. Our analysis targets the question of how insurance costs with vertebroplasty and kyphoplasty affect profit margins per G-DRG (German Diagnosis Related Groups) in consideration of the different system approaches of the providers. MATERIALS AND METHODS: After reviewing the literature, extremely varied, minimally invasive augmentation methods and techniques for treating vertebral body fractures were identified and classified. These were grouped based also [sic: on] OPS and possibly further subdivisions. Material costs were gathered based on average price quotations of different providers and techniques and aligned with those from the literature. The inpatient costs per day were estimated as a lump sum according to published information, since our analysis was interested in less detailed process costs as these are difficult to transfer to other clinics due to parameters being unique to each facility. The G-DRGs concerned were likewise determined according to the case-based lump sum catalogue from 2012. Based on this, the material costs as well as the daily costs per day of inpatient stay according to the average length of stay per G-DRG were subtracted. RESULTS: Vertebral augmentation methods are classified into vertebroplasty and kyphoplasty according to OPS. In addition, according to current literature, a further subdivision of kyphoplasty into substance-conserving or direct cement injection techniques and substance-destroying or indirect cement injection techniques took place. The procedures involve material costs between 10-40 % of G-DRG revenue. The profit margin of vertebral augmentation ranges from approx. 4100 € to approx. 11 400 €. The calculative costs of the inpatient care per day amount to 488.86 €. Based on the average lengths of stay per G-DRG (7.8-12.6 days) for 2012 determined by the InEK (Institut für das Entgeltsystem im Krankenhaus [Institute for the Hospital Remuneration System]), the financial costs of inpatient care were calculated between 3813.11 € and 6159.65 €. A shortfall of -197.53 € for the treatment of a vertebral body resulted for the vertebroplasty. This shortfall increases with the treatment of three vertebral bodies and a PCCL = 4 to -466.30 €. The indirect cement injection techniques accounted for a positive profit margin of 196.03 € for the treatment of a vertebra. Due to high material costs, however, this dips into the negative in the amount of -1227.70 € for two vertebrae and increases to -2522.50 € for the treatment of three vertebral bodies. In contrast, the multilevel care in substance-preserving kyphoplasty techniques show a positive profit margin of 72.30 € for the treatment of two vertebrae and 577.50 € for the treatment of three vertebrae. CONCLUSION: Against the background of the increasing economization of the health care system, it should be emphasized once more that the decision for a therapy or a system based on medical reasons should only be made by the treating physician. The vertebroplasty could not be performed at a profit in our analysis, despite comparatively low material costs. A shortfall between -197.53 € and -466.30 € was determined. The comparatively higher material costs of the kyphoplasty make comparisons important. The results of our investigation also show that supposedly inexpensive purchases of materials are not automatically a favorable alternative. In addition, the kyphoplasty techniques currently available on the market are not necessarily comparable. According to our investigation, profits of between 196.03 € and 577.50 € are to be realized in the selection of vertebral augmentation systems based on purely economic considerations. The results of our analysis show that the pure comparison of figures of the average material costs of a G-DRG and the material price distort the picture. A calculation of the profit margin on the basis of costs of care per vertebral body is more definitive.

[Radiofrequency kyphoplasty - an innovative method for the treatment of vertebral compression fractures - comparison with conservative treatment]. / Radiofrequenz-Kyphoplastie - ein innovatives Verfahren zur Behandlung von vertebralen Kompressionsfrakturen - Vergleiche mit konservativer Behandlung.

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.

[Long-term efficacy and safety of balloon kyphoplasty for treatment of osteoporotic vertebral fractures]. / Langzeitwirksamkeit und Sicherheit der Ballon-Kyphoplastie zur Behandlung osteoporotischer Wirbelkörperfrakturen.

OBJECTIVE: The aim of the evaluation of treatment protocols was an extension of the documentation regarding efficacy, duration of action and safety of balloon kyphoplasty. In addition, the data analysis should be used to clarify whether differences arise concerning the treatment success, depending on the number and/or position of the augmented vertebral bodies. MATERIALS AND METHODS: The data of all patients who were admitted and operated on for vertebral body fractures between 2004 and 2009 were collected and evaluated for this study. The patients were examined pre-operatively and during the control visits clinically and radiologically. The intensity of pain was recorded on a visual analogue scale (VAS: 0-100 mm). To determine the functional limitations the Oswestry questionnaire was used. In addition, the middle and anterior heights of the vertebral body and the kyphosis angle were measured. To perform the balloon kyphoplasty the Kyphon® system was applied. The findings of all patients were documented in order to evaluate the efficacy and safety of balloon kyphoplasty for up to 3 years and to compare them with regard to the differences depending on the number and/or location of vertebral fractures (T = 1, T > 1, L = 1, L > 1, T + L). RESULTS: The overall evaluation of all patients (n = 464) in whom a balloon kyphoplasty was carried out showed an average improvement in VAS scores by 53 mm and the Oswestry scores by 47 percentage points. It was possible to demonstrate a significant improvement of the vertebral body height (mean 1.6 mm) and the kyphosis angle (1.3 degrees) in long-term controls up to 3 years. When comparing the findings in the groups that had been operated on a different number of vertebrae and/or at different positions in the spinal region (n = 466) it could be proven that the average decrease in pain intensity did not differ in all 5 groups (> 50 mm). Also for the Oswestry scores the reduction was almost comparable in all 5 groups. The radiological findings did not show striking differences between the 5 groups. CONCLUSIONS: Balloon kyphoplasty was proven to be a safe and effective procedure. Thus, the balloon kyphoplasty in carefully selected patients can yield better results than a non-invasive conservative treatment. It contributes decisively a better quality of life for the operated patients and diminishes the risks of long-lasting treatment with drugs.

[Kiva® VCF Treatment System - clinical study on the efficacy and patient safety of a new system for augmentation of vertebral compression fractures]. / Kiva® VCF Treatment System - klinische Studie zur Wirksamkeit und Patientensicherheit mit einem neuen System zur Augmentation von vertebralen Kompressionsfrakturen.

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. 87 % 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.