Changes of static and dynamic spine alignment in patients with severe haemophilia.

INTRODUCTION: Haemophilic arthropathy results in a restricted range of motion and pain that often affects gait. The effect of these gait changes on spinal posture has not been studied. AIM: To evaluate whether the altered joint situation in patients with haemophilia (PwH) leads to compensatory mechanisms evident in the trunk and spine, considering static and dynamic conditions. METHODS: PwH and healthy controls (20-65 years) were examined using rasterstereography in a controlled cohort study. Analysis was performed in static and dynamic conditions in regard to gait phases. Joint status was determined using the Haemophilia Joint Health Score (HJHS). RESULTS: Static measurements showed no group differences in PwH (n = 40) compared to healthy controls (n = 40) except pelvic torsion (median [25%-quartile;75%-quartile]: -1.9[-3.2;.9]° vs. .5[-1.1;1.9]°; P = .007). In contrast, under dynamic conditions PwH showed significantly higher trunk inclination and lower apex lumbar lordosis in all gait phases. Additionally, pelvic torsion was increased in mid stance and terminal swing. Considering joint status, PwH had a higher global HJHS (23.5[13.0;30.0] vs. 3.0[1.0;5.0]; P<.001). A significant moderate correlation was shown between the HJHS mobility score and spine parameters (r = .228-.588; P<.05). CONCLUSION: Degenerative joint changes in PwH lead to altered spine posture during gait. A reason could be the reduced mobility in the affected joint. Changes in spinal and pelvic posture lead to higher structural burdens; therefore, clinicians should focus on posture of spinal column during gait in daily treatment.

Cross-sectoral Analysis of 1.4 Million AOK-insured Patients with Back Pain in Baden-Württemberg - What Influence does Outpatient Specialist Care Have? / Sektorenübergreifende Rückenschmerz-Versorgungsanalyse von 1,4 Mio. AOK-Versicherten in Baden-Württemberg ­ welchen Einfluss hat die ambulante fachärztliche Versorgung?

BACKGROUND: Back pain is one of the leading causes of disability globally and the most common musculoskeletal pain in Germany. The lifetime prevalence of back pain ranges from 74% to 85%, and the point prevalence ranges from 32% to 49%. One in five individuals with statutory health insurance visits a doctor at least once a year for back pain, and 1 in 20 individuals is on sick leave at least once a year. The question as to what extent can different outpatient care concepts substantially contribute to improving care and avoiding inpatient hospital treatment has repeatedly been the subject of controversial political discussions. This study aimed to present a description of the reality of care in Baden-Württemberg (BW), Germany, based on claims data. MATERIAL AND METHODS: Anonymised routine billing data of AOK Baden-Württemberg were analysed in compliance with data protection regulations. The billing data cover the outpatient and inpatient care sectors. All AOK patients in BW who received at least one ICD10 diagnosis from their physician in the first half of 2015 were considered for the analysis. Patients with at least one diagnosis of back pain were evaluated as patients with back pain, whereby the assignment to the diagnosis group of specific or non-specific back pain was made based on the code. RESULTS: In the first half of 2015, nearly 988 925 patients with back pain were registered in the 6696 primary care clinics in BW, approximately 302 524 patients in 1172 orthopaedic clinics and 17 043 patients in 89 neurosurgical clinics. Primary care clinics reported back pain diagnosis in 34.6%, orthopaedic clinics in 51.9% and neurosurgical clinics in 78.6% of cases. Primary care clinics diagnosed a specific cause in approximately one-third of patients with back pain, orthopaedic clinics in approximately 40% of their patients and neurosurgery clinics in one in two cases. Overall, approximately 1.2% of 1.3 million patients with back pain (January to December 2015 in BW) were hospitalised. Inpatient therapy consisted of surgical therapy and conservative therapy. Nucleotomy, decompression and spondylodesis were the three most common surgical procedures performed. Pain medication and remedy prescriptions decreased pain after spinal surgery. There are significant regional differences in referral and surgery rates. The mean inpatient referral rate was 535 of 100 000 AOK insurants, and the median was 536 of 100 000 AOK insurants. The mean surgery rate among all admitted patients with back pain was 49.9%, and the median was 49.8%. CONCLUSION: The vast majority of patients with back pain are treated as outpatients. Only approximately 1.2% of all patients with back pain were treated as inpatients in 2015. Of these, approximately half underwent surgery. Spinal surgeries led to a decrease in pain medication and remedy prescription postoperatively. The three most frequent surgical procedures were 'decompression', 'excision of disc tissue' and 'spondylodesis'. There were significant regional differences.

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.

Influence of radiofrequency kyphoplasty on pulmonary function.

BACKGROUND: Vertebral compression fractures (VCF) change the natural spinal alignment and inevitably lead to a decreased quality of life. OBJECTIVE: The aim of the study was to evaluate changes in pulmonary function after VCF were treated by radiofrequency kyphoplasty (RF-TVA). METHODS: Twenty-five patients were treated with RF-TVA and analyzed in 3 subgroups taking into account the spinal location of the VCF. Pain as measured by visual analogue scale (VAS), Oswestry-Disability-Index (ODI), vertebral height, forced expiratory volume in 1 second (FEV1), and peak expiratory flow (PEF) were assessed before, directly after and 30 days after RF-TVA. RESULTS: The mean vertebral height was improved in all subgroups, with a minor reduction from one to 30 days postoperatively. The mean VAS and ODI significantly decreased in the main and upper diaphragm groups from baseline to the follow-up after 30 days. Patients treated below the main diaphragm region showed a significant improvement of ODI and a clear trend to significant improvements of VAS. PEF and FEV1 were significantly improved in the main diaphragm group. FEV1 also increased significantly in the upper diaphragm group with a clear trend to significance in the lower diaphragm group. CONCLUSIONS: Results indicate that RF-TVA may improve pulmonary function especially in cases where fractures are located in the main spinal region of the diaphragm.

Interaction of radiation therapy and radiofrequency kyphoplasty in the treatment of myeloma patients.

BACKGROUND: 30% of myeloma patients suffer from vertebral compression fractures (VCF). Consequently, augmentation often becomes inevitable to prevent further problems. This study evaluated the interaction of radiation therapy (RT) and radiofrequency kyphoplasty (RFK) in the treatment of myeloma associated VCF. METHODS: Eighty-six myeloma patients with VCF were treated with RFK followed by radiation therapy (RFK group) or vice versa (RT group). Visual analgoue scale (VAS), Oswestry-Disability-Index (ODI), vertebral height and kyphosis angle were assessed preoperatively, 3-4 days, 3 and 6 months postoperatively. Adverse events like cement leakage or additional fractures were documented. RESULTS: Both groups achieved comparable outcomes, but the course of VAS and kyphosis angle differed. Early postoperative kyphosis angles improved significantly in the RFK group, but significantly worsened afterwards. The RT group showed a trend towards significantly improvement postoperatively and minor worsening afterwards. VAS remained constant in the RT group and worsened in the RFK group after 6 months. More cement leakages and additional fractures were noted in the RT group. CONCLUSIONS: RFK is an effective method for treating VCF in myeloma patients independent of treatment order with regard to radiation therapy. However, RT should be conducted after RFK to minimize risks of cement extrusion and additional fractures.

Elastoplasty: A Silicon Polymer as a New Filling Material for Kyphoplasty in Comparison to PMMA.

BACKGROUND: Painful vertebral compression fractures (VCF) caused by osteoporosis are a common health problem in the elderly population. If conservative treatments are unsuccessful, surgical treatments like vertebroplasty or kyphoplasty are recommended. But the use of Polymethylmethacrylat (PMMA) bone cement for augmentation surgery is associated with risks. OBJECTIVES: Evaluation of the effectiveness and safety of a newly developed silicon polymer (VK100) that can be used instead of PMMA bone cement for kyphoplasty treatments. STUDY DESIGN: A retrospective study of 30 patients comparing the outcomes of kyphoplasty treatments conducted with PMMA and VK100. SETTING: Clinic for Orthopedics and Trauma Surgery Bonn, Germany. METHODS: Thirty patients with one to 3 VCF were treated either with balloon kyphoplasty using VK100 or balloon kyphoplasty using PMMA bone cement. Data from both groups was compared by a matched pair analysis. The medial vertebral height was measured at each examination radiologically. The patients stated their pain intensity using the Visual Analogue Scale (VAS) and the patient's functional impairment was evaluated with the Oswestry-Disability-Index (ODI).All data were assessed before surgery, and 3 days, 3 months, 6 months, and 12 months after surgery. Intraoperative and postoperative adverse events were documented. RESULTS: The patients' functional impairment and pain improved significantly after surgery. The course of ODI and VAS was comparable in both treatment groups, but the improvement in the VK group was significantly ongoing until the 12 month follow-up. Vertebral height improvement was significant in both groups, but the PMMA group achieved a better absolute restoration. The vertebral height stayed constant during the follow-up in the VK group and worsened significantly in the PMMA group. There was no significant difference between groups concerning the occurrence of additional fractures; and no other types of complications or surgery-related adverse events were observed in either the PMMA group or in the VK group. LIMITATIONS: The study is only a matched pair analysis of 15 patients for each procedure and the amount of injected filling material was not recorded. CONCLUSION(S): The study results demonstrate that the clinical outcome of VAS and ODI of using the silicon polymer VK100 is comparable or slightly better than using PMMA. VK 100 shows a trend to minor additional fractures during the follow-up. However, height restoration is not satisfactory in comparison to PMMA, although vertebral height stayed more or less constant in the VK group. To address the augmentation success further, it would be necessary to study a larger patient group over a longer study period and to assess additional parameters such as bone density and injected amount of filling material.

Clinical efficacy and safety of a new flexible interbody spacer system.

BACKGROUND: Patients with lumbar degenerative disk disease (DDD) often require an interbody fusion. Several spacer systems have been developed to achieve an adequate fusion. The newly developed flexible interbody spacer system (Luna®, Benvenue Medical Inc.) expands to the disk space and is adjustable to the patient's anatomy. OBJECTIVE: Prospective monocentric evaluation of interbody fusions performed with the new system in patients with DDD to assess the device's efficacy and safety. METHODS: The study includes patients with DDD of one or two contiguous lumbar levels. All patients were treated with the new flexible cage system. To evaluate the clinical outcome, examinations were conducted preoperatively, 6 weeks, 6 months and 12 months postoperatively. At each study visit possible implant loosening was assessed by plain radiography and any adverse events were documented. Furthermore, back pain was evaluated using the visual analogue scale (VAS), functional impairment using the Oswestry-Disability-Index (ODI) and quality of life using the SF36. RESULTS: A total of 30 patients (age: 52.8 ± 11 years, gender: 53% male) were included. None of the patients showed signs of implant loosening and the total number of adverse events was low (3%). The VAS improved significantly from 81.2 ± 9.5 mm at baseline to 28 ± 26.2 mm after 12-months (p ≤ 0.0001). The ODI also improved significantly from 57.9 ± 9.6% at baseline to 20 ± 15.6% after 12-months (p ≤ 0.0001). The physical component score (PCS) of the SF36 improved significantly ongoing from 29.2 ± 9.3 at baseline to 56.1 ± 14.9 after 12-months (p = 0.0079) and the mental component score (MCS) improved significantly from 49.2 ± 20.7 at baseline to 62.8 ± 18.9 after 12 months (p = 0.013). CONCLUSIONS: Minimal-invasive lumbar interbody fusion with the new flexible system is a safe and effective treatment method for patients with DDD. Complication rates are low and treatment leads to an improvement of pain, functional impairment and quality of life.

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 balloon kyphoplasty with the new Kiva® VCF system for the treatment of vertebral compression fractures.

BACKGROUND: Vertebral compression fractures are common among the elderly, which is conditioned by osteoporosis. They cause back pain and limit the patient's activities. The Kiva® VCF Treatment System is a new device to treat vertebral compression fractures. Compared to other methods, the utilization of the Kiva System reduces the risk for complications and delivers improvements in back pain reduction and functionality. OBJECTIVES: Evaluation of safety and effectiveness of the Kiva System in comparison to balloon kyphoplasty on the basis of matched pairs. METHODS: 52 patients (47 - 89 years, 68 fractures) were treated with balloon kyphoplasty or with the new Kiva System. Back pain and impairment of motility were assessed preoperatively and 6 months postoperatively, with the Visual Analog Scale (VAS) and Oswestry Disability Index (ODI). The operation time and cement extravasation were recorded. Control radiographs were evaluated for new fractures and vertebral heights. RESULTS: Mean VAS values in both groups improved from preoperatively 87.6 ± 12.8 and 83.1 ± 14.9 to 10.8 ± 20.8 and 24.6 ± 11.0 6 months after the treatment. The improvement after 6 months in the Kiva group was significantly better than in the balloon kyphoplasty group (P < 0.0001). Mean ODI scores in both groups also improved from 68.7% ± 15.8% in the Kiva group and 80.6% ± 8.6% in the balloon kyphoplasty group preoperatively to 24.8 ± 18.6% and 33.2 ± 6.3% 6 months after treatment. The mean operation time for the Kiva group was 12.7 ± 3.7 minutes per vertebra and cement leakage occurred in 6 patients. The mean operation time for the balloon kyphoplasty group was 34.1 ± 7.0 minutes per vertebra and cement leakage occurred in 8 patients. Anterior and mid vertebral height in the Kiva group increased from preoperatively 21.06 ± 7.44 mm and 18.36 ± 5.64 mm to postoperatively 22.41 ± 7.14 mm and 20.41 ± 6.00 mm. Anterior and mid vertebral height in the balloon kyphoplasty group increased from preoperatively 21.68 ± 2.06 mm and 21.97 ± 1.78 mm to postoperatively 25.09 ± 2.54 mm and 25.29 ± 2.10 mm. Vertebral height restoration could be therefore maintained with both procedures for 6 months. In the Kiva group 2 cases of nonadjacent fractures and one case of adjacent fractures were observed. In the balloon kyphoplasty group 9 cases of adjacent, as well as 5 cases of nonadjacent, fractures were observed. In the Kiva group significant fewer fractures occurred. LIMITATIONS: The study includes only 26 patients for each procedure, which were compared on the basis of matched pairs. CONCLUSION: The Kiva System appears to be a safe and effective procedure for the treatment of vertebral compression fractures. Six months after treatment with the Kiva System, better VAS values than the values after the treatment with balloon kyphoplasty were recorded. Reduction in functional impairment was as successful as it was after balloon kyphoplasty. Vertebral height restoration was observed in both groups, which was sustained for 6 months. The risk of cement extravasation during the Kiva Treatment is nearly the same as in balloon kyphoplasty; however, it requires a shorter operation time and produces less new fractures.