Clinical Neuroscience

[Treatment of osteoporotic vertebral compression fracture with PMMA augmented pedicle screw fixation]

PADÁNYI Csaba, MISIK Ferenc, PAPP Zoltán, VITANOVICS Dusan, BALOGH Attila, VERES Róbert, LIPÓTH László, BANCZEROWSKI Péter

JANUARY 30, 2015

Clinical Neuroscience - 2015;68(01-02)

[Background - Over the last few decades many innovative operation technique were developed due to the increase of porotic vertebral fractures. These new techniques aim to reach the required stability of the vertebral column. In case of significant instability, spinal canal stenosis or neural compression, decompressive intervention may be necessary, which results in further weakening of the column of the spine, the minimal invasive percutan vertebroplasty is not an adequate method to reach the required stability, that is why insertion of complementary pedicular screws is needed. Considering the limited screw-fixing ability of the porotic bone structure, with this new technique we are able to reach the appropriate stability of cement-augmented pedicle screws by dosing cement carefully through the screws into the vertebral body. We used this technique in our Institute in case of 12 patients and followed up the required stability and the severity of complications. Methods - Fifteen vertebral compression fractures of 12 patients were treated in our Institute. Using the classification proposed by Genant et al. we found that the severity of the vertebral compression was grade 3 in case of 13, while grade 2 in case of two fractures. The average follow up time of the patients was 22 months (12-39), during this period X-ray, CT and clinical control examinations were taken. During the surgery the involved segments were localised by using X-ray and after the exploration the canulated screws were put through the pedicles of the spine and the vertebral body was filled through the transpedicular screws with bone cement. Depending on the grade of the spinal canal stenosis, we made the decompression, vertebroplasty or corpectomy of the fractured vertebral body, and the replacement of the body. Finally the concerned segments were fixed by titanium rods. Results - In all cases the stenosis of spinal canal was resolved and the bone cement injected into the corpus resulted in adequated stability of the spine. In case of six patients we observed cement extravasation without any clinical signs, and by one patient - as a serious complication - pulmonary embolism. Neurological progression or screw loosening were not detected during the follow up period. Part of the patients had residual disability after the surgery due to their older ages and the problem of their rehabilitation process. Conclusion - After the right consideration of indications, age, general health condition and the chance of successful rehabilitation, the technique appears to be safe for the patients. With the use of this surgical method, the stability of the spine can be improved compared to the preoperative condition, the spinal canal stenosis can be solved and the neural structures can be decompressed. The severity of complications can be reduced by a precise surgical technique and the careful use of the injected cement. The indication of the surgical method needs to be considered in the light of the expected outcome and the rehabilitation.]

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Clinical Neuroscience

[Greetings]

RAJNA Péter, TAJTI János

Clinical Neuroscience

[Extending therapeutic possibilities in relapsing-remitting multiple sclerosis: dimethyl fumarate]

MATOLCSI Judit, RÓZSA Csilla

[Dimethyl fumarate (DMF) is a novel oral therapy that has recently been approved for the treatment of relapsing- remitting multiple sclerosis (RRMS). Dimethyl fumarate shows anti-inflammatory and cytoprotective properties that are thought to be mediated primarily via activation of the nuclear factor (erythroid-derived 2)-like 2 - Nrf2 transcriptional pathway, which up-regulates the genes involved in the cellular response to oxidative stress. The drug was evaluated in 2 large, randomized, double-blind, multicentric, multinational, 2-year, phase III clinical trials. The DEFINE and CONFIRM trials, conducted with over 2600 adult patients suffering from RRMS, unequivocally confirmed the efficacy of DMF (2×240 mg daily) in reducing the annualized relapse rate (ARR) and reducing the proportion of patients with MS relapse at 2 years. Significantly reduced sustained disability progression was observed with the drug versus placebo in DEFINE, while the same tendency was seen in CONFIRM. The MRI results of the studies were also convincing: DMF significantly reduced the number of new/enlarging T2-hyperintense lesions and the number of Gd-enhancing lesions compared to placebo. Dimethyl fumarate was generally well tolerated and no safety concern has been raised. Adverse events that occurred most frequently included flushing and gastrointestinal events. The long- term efficacy and tolerability of dimethyl fumarate is currently being investigated in the ENDORSE trial, with interim results demonstrating the same results as the two previous studies. In conclusion, although further, mostly comparative data are needed to fully establish the relative efficacy and tolerability of dimethyl fumarate compared with other therapies, dimethyl-fumarate is a valuable addition to the therapeutic options available for RRMS.]

Clinical Neuroscience

[Role of modified open-door laminoplasty in the treatment of multilevel cervical spinal stenosis: a retrospective analysis of 43 cases]

VITANOVICS Dusan, BÁRÁNY László, PAPP Zoltán, PADÁNYI Csaba, BALOGH Attila, BANCZEROWSKI Péter

[Background and purpose - Symptomatic degenerative multilevel cervical spinal stenosis - beside other methods - is often treated using the open-door laminoplasty. This procedure aims to decompress the spinal cord and preserve the stability of the cervical spine. The efficiency and safety of the method was proved by numerous Japanese and American studies, also the technique related complications are well known. We treated 43 patients with symptomatic multilevel cervical spine stenosis using the open-door laminoplasty as a surgical procedure of choice in the National Institute of Clinical Neurosciences between 2009 and 2012. In this article we analyse our results and the related literature is discussed. Methods - Symptomatic patients with a minimum of three-segment cervical spine stenosis and radiologically proved myelopathy or with electrophisiologically verified subclinical myelopathy were selected for laminoplasty. Patients in whom cervical kyphosis was present were operated on using laminectomy and posterior fusion. Postoperative control CT, MRI and/or X-ray images were made after the surgery and at six weeks, three, six and 12 months after the operation and in the same time neurological evaluation was performed. The modified Japanase Orthopaedic Association (mJOA) scale value was assigned to patients preoperatively, six weeks, three, six and 12 months after the operation. The statistical difference between the groups of data was tested by chi square test. Results - The average follow-up time was 27 months (minimum seven, maximum 42). According to the mJOA scale, 26 patient’s condition (61%) improved, in 13 cases (30%) remained unchanged, and in one case (2%) we detected neurological deterioration. We lost three patients during the follow up period. The median of mJOA preoperatively was 12 (minimum eight, maximum 18), while six week postoperative mJOA was 14 (minimum 10, maximum 17). Three, six and 12 months mean value of mJOA was 14 which shows that the improvement in patients’ condition remained stable at one year after surgery. The difference was statistically significant (p<0.05). The canal’s average anteroposterior diameter on CT was 8.29±0.92 mm at the level of C III, while after the operation we measured 15.16±1.02 mm; 7.54±0.62 mm at the level of C IV before, and 15.29±0.2 mm after; 9.05±0.48 mm at the level of C V before and 17.23±0.4 mm after the surgery. The differences proved to be significant (p=0.0001). Conclusion - According to our experiences the modified open-door laminoplasty is an efficient and safe method for the treatment of symptomatic multilevel cervical spinal stenosis.]

Clinical Neuroscience

[The efficacy of lacosamide in relation to antiepileptic drug history. Clinical experiences in adult partial epilepsy]

BARCS Gábor, SZŰCS Anna, HORVÁTH András, KAMONDI Anita

[Objective - A retrospective study in adult partial epilepsy on the efficacy of lacosamide in relation to previous antiepileptic drug experiences. Method - We analysed 3-65 months’ data on epilepsy-care of 43 pharmacoresistant partial epilepsy patients treated with lacosamide. Further analysis of antiepileptic drug history was carried out in strictly selected subgroups of patients with good and poor therapeutic response to lacosamide (10 and 9 patients, respectively) for 2-10 years long retrospective follow up. Patients - Adult patients with partial-onset seizures had been treated previously with three or more lifetime antiepileptic drugs without permanent success. Results - Six patients (14%) were seizure free, eleven patients (25%) have experienced important improvement (their seizure-frequency decreased by at least 50%) for more than 12 months. Fourteen patients (32%) improved for less than 6 months and then have relapsed; and add-on lacosamide proved ineffective in 12 patients (28%). Those selected 10 patients successfully treated with lacosamide (seizure free for at least six months) favourably responded to carbamazepine or oxcarbazepine earlier and levetiracetam was ineffective or even caused worsening. The selected lacosamide-unresponsive nine patients responded unfavourably to carbamazepine or oxcarbazepine earlier. Fifteen patients (35%) suffered side effects as dizziness or sleepiness, in 11 of them lacosamide was combined with a „traditional” sodium-channal blocker antiepileptic drug. Conclusion - Lacosamide is an effective add-on antiepileptic drug in difficult-to treat adult partial epilepsy patients. Our data suggest that good lacosamide response may be expected in those patients who reacted favourably to „traditional” sodium-channel blocker carabamazepine or oxcarbazepine earlier.]

Clinical Neuroscience

[Assessment of severity and time course of critical illness neuropathy in septic patients: a prospective observational study]

NEMES Réka, FÜLEP Zoltán, LÁSZLÓ István, SÁRKÁNY Péter, FEKETE Klára, MECHLER Ferenc, FÜLESDI Béla

[Objective - In this prospective observational study we investigated electrophysiological alterations in the early phase of critical illness and correlated electrophysiological findings with the clinical picture and outcome. Methods - We enrolled 21 critically ill surgical patients having ≥12 Acute Physiology and Chronic Health Evaluation (APACHE) II scores on admission. Routine non-invasive bilateral electroneurography (ENG) examination of median and ulnar nerves was done on five consecutive days starting in two days after admission. Then weekly follow-up was performed. Motor and sensory nerve conduction indices were calculated and correlated with APACHE II and Simplified Acute Physiology Score II severity scores. Results - On the first examination 18/21 patients had >20% reduction in the motor and sensory nerve conduction indices. Severity score systems showed significant negative correlation with the daily change of CMAP and SNAP amplitudes and calculated nerve conduction indices (Spearman’s correlation, p<0,001). Mortality was higher in the patients with worse admission ENG and/or stagnant electrophysiological status or declining tendency in the first week. Conclusions - Electrophysiological alterations appeared soon after the development of critical illness. Early phase alterations showed a strong correlation with patients’ general condition and more severe electrophysiological alterations predisposed to higher mortality. In several cases early alterations proved to be reversible. ]

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Clinical Neuroscience

Management of bone metabolism in epilepsy

UÇAN TOKUÇ Ezgi Firdevs , FATMA Genç, ABIDIN Erdal, YASEMIN Biçer Gömceli

Many systemic problems arise due to the side effects of antiepileptic drugs (AEDs) used in epilepsy patients. Among these adverse effects are low bone mineral density and increased fracture risk due to long-term AED use. Although various studies have supported this association with increased risk in recent years, the length of this process has not been precisely defined and there is no clear consensus on bone density scanning, intervals of screening, and the subject of calcium and vitamin D supplementation. In this study, in accordance with the most current recommendations, our applications and data, including the detection of possible bone mineralization disorders, treatment methods, and recommendations to prevent bone mineralization disorders, were evaluated in epilepsy patients who were followed up at our outpatient clinic. It was aimed to draw attention to the significance of management of bone metabolism carried out with appropriate protocols. Epilepsy patients were followed up at the Antalya Training and Research Hospital Department of Neurology, Epilepsy Outpatient Clinic who were at high risk for osteoporosis (use of valproic acid [VPA] and enzyme-inducing drugs, using any AED for over 5 years, and postmenopausal women) and were evaluated using a screening protocol. According to this protocol, a total of 190 patients suspected of osteoporosis risk were retrospectively evaluated. Four patients were excluded from the study due to secondary osteoporosis. Of the 186 patients who were included in the study, 97 (52.2%) were women and 89 (47.8%) were men. Prevalence of low bone mineral density (BMD) was 42%, in which osteoporosis was detected in 11.8% and osteopenia in 30.6% of the patients. Osteoporosis rate was higher at the young age group (18-45) and this difference was statistically significant (p=0.018). There was no significant difference between male and female sexes according to osteoporosis and osteopenia rates. Patients receiving polytherapy had higher osteoporosis rate and lower BMD compared to patients receiving monotherapy. Comparison of separate drug groups according to osteoporosis rate revealed that osteoporosis rate was highest in patient groups using VPA+ carbamazepine (CBZ) (29.4%) and VPA polytherapy (19.4%). Total of osteopenia and osteoporosis, or low BMD, was highest in VPA polytherapy (VPA+ non-enzyme-inducing AED [NEID]) and CBZ polytherapy (CBZ+NEID) groups, with rates of 58.3% and 55.1%, respectively. In addition, there was no significant difference between drug groups according to bone metabolism markers, vitamin D levels, and osteopenia-osteoporosis rates. Assuming bone health will be affected at an early age in epilepsy patients, providing lifestyle and diet recommendations, avoiding polytherapy including VPA and CBZ when possible, and evaluating bone metabolism at regular intervals are actions that should be applied in routine practice.

Ca&Bone

[Evaluation of quality of life following treatment with calcitonin nasal spray in patients with osteoporosis: preliminary results of the MERLIN study]

BORS Katalin, KÓSA József, BORBÉLY Judit, TABÁK Ádám, HORVÁTH CSABA

[INTRODUCTION - MERLIN (Management of Osteoporosis in Elderly with Calcitonin) is an open-label, multicenter, prospective, follow-up study conducted in Hungary, part of which is to assess the impact of treatment with Miacalcic, - an intranasal salmon calcitonin, on the quality of life (QoL) among patients with osteoporosis. In this paper we report the preliminary results of the MERLIN study. PATIENTS - The study initially involved 1949 senior patients (aged >65 years) to whom calcitonin was prescribed for osteoporosis according to the application instructions. Patients presented at outpatient clinics and consisted of two groups; they were either newly diagnosed or they had been receiving a therapy for osteoporosis other than calcitonin. METHODS - This latter group discontinued their previous treatment and all patients received 200 IU intranasal salmon calcitonin (SCT) once daily for three months. Patient and physician questionnaires were used to collect information on the patients' QoL (EQ-5D VAS) and their general well-being at baseline and at follow-up visits at week 4 and week 12. RESULTS - Calcitonin use was associated with improvements in all EQ-5D domains and component scores as well as in VAS. Patients with previously known osteoporosis who, switched to calcitonin therapy achieved better results (0,046 QALY), than the newly diagnosed patients (0,0405 QALY). CONCLUSIONS - We conclude that intranasal SCT 200 IU daily is safe and effective in improving QoL of both, male and female patients with low bone mineral density.The conclusions that can be drawn from this study are limited due to the lack of a control group and to the unblinded design. Further placebo-controlled studies are needed to confirm these results. Nevertheless, our study was the first in Hungary to evaluate the quality of life impact of an osteoporosis treatment, and hopefully it will be followed by more such studies directed to other osteoporosis treatments.]

Ca&Bone

[Bone metabolism and body mass index in postmenopausal women]

TÁRCZY Csaba, TOLDY Erzsébet, SZERB János, VARGA László

[INTRODUCTION - In addition to several other causes constitutional factors play an important role in the development of osteoporosis.Various aspects of bone metabolism were examined to explain the differences in bone density between women with low and high body mass index (BMI). PATIENTS AND METHOD - One hundred and ninetytwo postmenopausal women were included in the study. Bone density was measured by forearm densitometry.To assess bone formation, serum osteocalcin levels were measured, while the rate of bone absorption was estimated from C-terminal telopeptide levels of collagen type I measured in urine and blood. RESULTS - The prevalence of osteoporosis was higher in women with low BMI than in those with normal or higher BMI. Bone metabolism - both formation and absorption - was increased in both groups, however, in women with low BMI this increase was more pronounced and bone metabolism tended to be shifted to absorption compared to patients with normal or higher BMI. CONCLUSION - Postmenopausal lean women have accelerated bone metabolism compared to obese women. This fact and the shift to absorption may be the main reasons for the higher frequency of osteoporosis found by densitometry in women with low BMI than in those with higher BMI.]

Ca&Bone

[Bone mineral density and diabetes mellitus - First results]

TÕKE Judit, TAMÁS GYULA, STELLA Péter, NAGY Erzsébet, NÁDASDI Ágnes, VARGA Piroska, KERÉNYI ZSUZSA

[INTRODUCTION - Data on bone mineral density (BMD) in diabetes mellitus are contradictory in the literature. Early studies described a decreased bone mineral density in type 1 diabetes mellitus (T1DM), but recent studies report no osteopenia in T1DM.The BMD may depend on the quality of treatment for diabetes mellitus and on the presence of chronic complications. In type 2 diabetes mellitus (T2DM) the BMD is not decreased, occasionally it can even be increased. PATIENTS AND METHODS - Bone mineral density was measured in 122 regularly controlled diabetic patients (T1DM: n=73, mean age: 43.6±11.1 years,T2DM: n=49, mean age: 61.8±9.8 years) by dual energy X-ray absorptiometry at the lumbar spine and at the femur. Results were compared to those of 40 metabolically healthy control persons with a mean age of 47.5±11.9 years.The patients’ carbohydrate metabolism was assessed by the average HbA1c level of the last three years.These values were 7.9±1.4 % in T1DM, and 7.5±1.7 % in T2DM. BMDs were classified based on the T-score and Z-score using the WHO criteria. RESULTS - There was no significant difference in T1DM or in T2DM compared to the reference group in the prevalence of either osteoporosis or of osteoporosis and osteopenia combined. CONCLUSION - BMD was not found to be decreased in patients with well-controlled metabolism compared to healthy controls.]

LAM KID

[„HOPE for people with fracture”: Results of the HOPE (Hungarian Osteoporosis Project for Elderly) study]

SPEER Gábor, NÁDAS Katalin, FERENCZ VIKTÓRIA, MÉSZÁROS SZILVIA, HORVÁTH CSABA, BORS Katalin

[We conducted a multicentre, prospective, single cross-sectional, 12-month, open-label study for the assessment of treatment satisfaction using TSQM (Treatment Satisfaction Questionnaire for Medication) for zoledronic acid therapy used in patients with osteoporosis, who suffered minor traumatic fractures. PATIENTS AND METHODS - In total 1736 patients from 94 centers completed the study and filled in the TSQM questionnaire at both visit 1 and visit 2. TSQM is suitable for measuring the patient’s satisfaction with a treatment, by evaluating side-effects, efficacy and convenience of the treatment and the patient’s overall satisfaction rated on a scale of 0 to 100. RESULTS - Patients included in the study previously received a mean of 1.58 other therapies for osteoporosis and their case history included a mean of 1.24 fractures. This real-life study demonstrated that even one year of zoledronate treatment significantly (p<0.0001) improved the satisfaction of patients regarding efficacy (a mean change from a score of 56.15 to 70.89) as well as the occurrence of side-effects on a TSQM score. Regarding the convenience of treatment, the mean score increased from 62.96 to 79.34 (p<0.0001), whereas the overall treatment satisfaction changed from 59.3 to 75.48 by visit 2 (p<0.0001). CONCLUSIONS - Our study demonstrated beneficial TSQM results associated with zoledronic acid treatment, which is a basic requirement for appropriate adherence as well. ]