Rahel Bornemann

Comparison of clinical and radiological data in the treatment of patients with osteoporotic vertebral compression fractures using radiofrequency kyphoplasty or balloon kyphoplasty

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 (6.1 % 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.

Influence of smoking on spinal fusion after spondylodesis surgery: A comparative clinical study

BACKGROUND Smoking is a risk factor in the process of bone healing after lumbar spondylodesis, often associated with complications that occur intraoperatively or during follow-up periods. OBJECTIVE To assess if smokers yield worse results concerning lumbar interbody fusion than non-smokers in a clinical comparative setting. METHODS Spondylodesis outcomes in 50 patients, 34 non-smokers (mean 58 years; (range 29-81) and 16 smokers (mean 47 years; range 29-75) were compared preoperatively and one year after spondylodesis surgery using Oswestry-Disability-Index (ODI), visual analogue scale (VAS) and radiological outcome analysis of fusion-success. RESULTS Smokers showed a comparable ODI-improvement (p = 0.9343) and pain reduction to non-smokers (p = 0.5451). The intake of opioids was only reduced in non-smokers one year after surgery. Fusion success was significantly better in non-smokers (p = 0.01). CONCLUSIONS The results indicate that smoking adversely effects spinal fusion. Particularly re-operations caused by pseudarthrosis occur at a higher rate in smokers than in non-smokers.

Comparison of Radiofrequency-targeted Vertebral Augmentation with Balloon Kyphoplasty for the Treatment of Vertebral Compression Fractures: 2-year Results.

Study Design: A retrospective study. Objectives: The aim of this study was the evaluation of the safety and effectiveness of radiofrequency-targeted vertebral augmentation (RF-TVA) in comparison with balloon kyphoplasty (BK) for the treatment of acute painful vertebral compression fractures (VCFs) on the basis of matched pairs. Summary of Background: Vertebroplasty and BK are the common surgical interventions for the treatment of VCF. Both are effective and safe but pose some risks such as adjacent fractures and cement leakage. In 2009, RF-TVA was introduced as an innovative augmentation procedure for the treatment of VCF. Materials and Methods: A total of 192 patients (116 female; 51–90 y) with VCF (n=303) at 1 to 3 levels were treated with RF-TVA or BK. Functionality (Oswestry Disability Index), pain (visual analogue scale), vertebral height (anterior, middle), and kyphotic angle were evaluated over a 2-year period (postoperatively, 3–4 d, 3, 6, 12, and 24 mo). In addition, operating time and occurrence of cement leakage were recorded. Results: Pain and functionality were significantly improved after both treatments. In both groups, there was an increase in the vertebral height and a decrease in the kyphotic angle, which remained relatively consistent during 24 months. The incidence of cement leakage was 9.4% (n=9) in the RF-TVA group and 24.0% (n=25) in the BK group. The mean operating time with radiofrequency kyphoplasty was 25.9±9.9 minutes, and with balloon kyphoplasty 48.0±18.4 minutes. Conclusions: RF-TVA is a safe and effective procedure for the treatment of vertebral compression fractures when compared with BK. Improvement in pain and functional scores after RF-TVA are durable through 24 months postprocedure and remained better than those after 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 the kyphotic angle.

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

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).

Temperature distribution during radiofrequency ablation of spinal metastases in a human cadaver model: Comparison of three electrodes

BACKGROUND Radiofrequency ablation (RFA) temperatures reaching 45°C in adjacent tissues are cytotoxic to the spinal cord, nerves and surrounding tissues. OBJECTIVE This study compares different RFA electrodes with regard to the temperature distribution during ablation of spinal metastases. METHODS In vitro experimental study in isolated lumbar vertebrae of a human cadaveric spine. The temperature distribution of RFA electrodes was measured during ablation in human cadaveric lumbar vertebrae containing a simulated vertebral body lesion. The analysis compared a novel bipolar RFA electrode with two conventional monopolar RFA electrodes. A vertebral metastasis model was prepared in eight lumbar vertebrae for each electrode. Differences between the electrodes were evaluated with a one-way ANOVA. RESULTS The lowest temperature at the thermocouples adjacent to the simulated lesion was achieved when using the bipolar RFA electrode (46.4 ± 3.3°C), but temperature difference to the monopolar RFA electrodes was not significant. In the neural foramen and epidural space of lumbar vertebrae the maximal temperature measured when using the bipolar RFA electrode was 37.0 ± 0°C and 37.3 ± 0.7°C, which was significantly lower than during ablation via either of the monopolar RFA electrodes (p ≤ 0.001). CONCLUSIONS Temperatures in areas of adjacent tissue during RFA using a specific for spinal ablation designed electrode with integrated thermocouples were significantly lower compared to other electrodes, potentially reducing temperature related risks during ablation.

Two-year clinical results of patients with sacroiliac joint syndrome treated by arthrodesis using a triangular implant system

BACKGROUND Sacroiliac joint (SIJ) syndrome can cause various symptoms and may also be one reason for persistent low back pain, especially in patients with prior spinal fusions. If conservative treatments fail to improve symptoms, arthrodesis surgery can be considered. Minimally invasive approaches have emerged recently providing a good alternative to conventional methods. A novel triangular implant system (iFuse) can achieve an arthrodesis of the SIJ without the use of additional screws or bone material. OBJECTIVE Aim of the present study was an evaluation of short-term safety and efficacy of the implant system. METHODS Twenty-four patients were included in the study and treated with the iFuse system. In addition to demographic data, pain intensity (visual analogue scale) and functional impairment (Oswestry-disability index) were assessed prior to surgery and 1 month, 3 months, 6 months, 12 months and 24 months thereafter. During surgery and the follow up period all adverse events were documented and the correct implant position was controlled via plain radiographs. RESULTS VAS scores and ODI improved significantly directly after surgery from 84.3 ± 9.2 mm to 40.7 ± 9.2 mm and from 76.8 ± 9.2% to 40.7 ± 9.2 % (p < 0.001). The ODI improved further to 31 ± 5.4% after 24 months whereas the VAS improved until the 3 months examination and ten stayed constant between 27.7 mm and 26.5 mm to 27 ± 6.6 mm at 24 months. No adverse events, intraoperative complications, implant malpositioning or loosening could be recorded at any time. CONCLUSIONS The iFuse system is an effective and safe treatment for minimally invasive surgical arthrodesis of the SIJ. Pain and functional impairment can be significantly improved. However, in addition to this case series, further controlled studies are necessary, particularly in terms of a previous spinal fusion history.

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.

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.

Falling and fall risk in adult patients with severe haemophilia

The objective of this study was to define fall rates and to identify possible fall risk factors in adult patients with severe haemophilia. PATIENTS, MATERIAL, METHODS 147 patients with severe haemophilia A and B were evaluated using a standardized test battery consisting of demographic, medical and clinical variables and fall evaluation. RESULTS 41 (27.9 %) patients reported a fall in the past 12 months, 22 (53.7 %) of them more than once. Young age, subjective gait insecurity and a higher number of artificial joints seem to be risk factors for falling. CONCLUSION Falls seem to be a common phenomenon in patients with severe haemophilia. Fall risk screening and fall prevention should be implemented into daily practice.

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.