Correction to: Conducting an observational study during an economic crisis: analysis of the treatment and follow-up phase of Greek patients participating in the ExFOS study.

Unfortunately in the original publication, the affiliation of the author N. Papaioannou was incorrectly provided.

Conducting an observational study during an economic crisis: analysis of the treatment and follow-up phase of Greek patients participating in the ExFOS study.

OBJECTIVE: We present the subanalysis of the Greek cohort of the Extended Forsteo Observational Study (ExFOS), a multicenter, non-interventional, prospective, observational study evaluating the effect of teriparatide on fractures, back pain (BP), health-related quality of life (HR-QoL), and safety and compliance, in patients with osteoporosis treated for up to 24 months, with a post-treatment follow-up of at least 18 months. DESIGN: A total of 439 osteoporotic patients (92.2% female) were enrolled in Greece. New or worsened fractures, based on their physicians' assessment, as well as patients' self-assessment of HR-QoL and BP, compliance, and safety profile, were captured by validated questionnaires. RESULTS: In the ExFOS Greek cohort, fracture rates were low and mean bone mineral density (BMD) was numerically improved. Compliance with teriparatide remained high throughout the study, with 81.5% of subjects completing treatment. Only 0.7% of patients reported discontinuation due to adverse effects. A sustainable improvement in patient-perceived BP and HRQoL throughout treatment and follow-up was similar to that achieved by the European Forsteo Observational Study (EFOS). A lower than expected percentage of patients using antiresorptives following teriparatide was recorded. CONCLUSIONS: ExFOS reproduces the outcomes of EFOS, with a 6.5-year time interval between studies, in comparable cohorts of osteoporotic patients. Data should be interpreted in the context of observational study data collection, although summary statistics computed at each time point may overstate drug effect.

Study description and baseline characteristics of the population enrolled in a multinational observational study of extended teriparatide use (ExFOS).

OBJECTIVE: To better characterize patients who are currently being prescribed teriparatide in Europe, this article describes the study design and baseline characteristics of participants of the Extended Forsteo * Observational Study (ExFOS). RESEARCH DESIGN AND METHODS: ExFOS is a noninterventional, multicenter, prospective, observational study in men and women with osteoporosis treated with teriparatide during the course of normal clinical practice for up to 24 months and with a post-treatment follow-up of at least 18 months. MAIN OUTCOME MEASURES: Baseline characteristics, including history of fracture and back pain, and health-related quality of life (HRQoL, assessed using the EuroQol-5 Dimension [EQ-5D]). RESULTS: Of 1607 patients enrolled, 90.9% were women. At baseline, mean (standard deviation [SD]) age was 70.3 (9.8) years, and 85.8% of patients had a history of fracture (64.7% with ≥2 fragility fractures). Of those with historic fractures, 90.8% had vertebral fractures (67.8% had thoracic fractures). The mean (SD) of reported bone mineral density T-scores were -3.0 (1.2), -2.4 (1.0), and -2.5 (0.9) for lumbar spine, total hip (left), and femoral neck (left), respectively. Overall, 39.3% of patients had experienced ≥1 fall during the 12 months before enrollment. At baseline, 11.4% of patients were osteoporosis-treatment naïve and 15% were currently using glucocorticoids. The mean (SD) visual analog scale score for back pain during the last month was 50.7 (26.9), and 62.1% of patients experienced daily or almost daily back pain. The median EQ-5D health state value at baseline was 0.62 (first and third quartiles: 0.19, 0.74). CONCLUSIONS: Baseline characteristics of the ExFOS study cohort indicate that patients prescribed teriparatide in Europe have severe osteoporosis with highly prevalent vertebral fractures, frequent and disabling back pain, and a poor HRQoL, despite previous pharmacotherapy for osteoporosis. Limitations include non-randomization, lack of a comparator group, and patient self-report for data on prior medication and fracture history.

Early changes in biochemical markers of bone formation during teriparatide therapy correlate with improvements in vertebral strength in men with glucocorticoid-induced osteoporosis.

UNLABELLED: Changes of the bone formation marker PINP correlated positively with improvements in vertebral strength in men with glucocorticoid-induced osteoporosis (GIO) who received 18-month treatment with teriparatide, but not with risedronate. These results support the use of PINP as a surrogate marker of bone strength in GIO patients treated with teriparatide. INTRODUCTION: To investigate the correlations between biochemical markers of bone turnover and vertebral strength estimated by finite element analysis (FEA) in men with GIO. METHODS: A total of 92 men with GIO were included in an 18-month, randomized, open-label trial of teriparatide (20 µg/day, n = 45) and risedronate (35 mg/week, n = 47). High-resolution quantitative computed tomography images of the 12th thoracic vertebra obtained at baseline, 6 and 18 months were converted into digital nonlinear FE models and subjected to anterior bending, axial compression and torsion. Stiffness and strength were computed for each model and loading mode. Serum biochemical markers of bone formation (amino-terminal-propeptide of type I collagen [PINP]) and bone resorption (type I collagen cross-linked C-telopeptide degradation fragments [CTx]) were measured at baseline, 3 months, 6 months and 18 months. A mixed-model of repeated measures analysed changes from baseline and between-group differences. Spearman correlations assessed the relationship between changes from baseline of bone markers with FEA variables. RESULTS: PINP and CTx levels increased in the teriparatide group and decreased in the risedronate group. FEA-derived parameters increased in both groups, but were significantly higher at 18 months in the teriparatide group. Significant positive correlations were found between changes from baseline of PINP at 3, 6 and 18 months with changes in FE strength in the teriparatide-treated group, but not in the risedronate group. CONCLUSIONS: Positive correlations between changes in a biochemical marker of bone formation and improvement of biomechanical properties support the use of PINP as a surrogate marker of bone strength in teriparatide-treated GIO patients.

Disease-modifying anti-rheumatic drugs for refractory severe knee synovitis in patients with peripheral spondyloarthritis: efficacy and predictors of response.

OBJECTIVES: In this study we aimed to evaluate the efficacy of disease-modifying anti-rheumatic drugs (DMARDs) for severe knee synovitis, refractory to low-dose oral corticosteroids and/or non-steroidal anti-inflammatory drugs (NSAIDs) and intra-articular (IA) corticosteroid injections, in patients with peripheral spondyloarthritis (SpA). We also examined the association between the clinical response of knee synovitis and demographic and clinical parameters of the studied patients. METHOD: Patients with SpA-related arthritis including resistant and severe knee synovitis, defined as the presence of swelling, tenderness, and a decreased range of movement on clinical examination, treated with DMARDs between January 2005 and January 2012 were studied retrospectively. No evidence of knee synovitis was considered a clinical response to DMARDs. RESULTS: Forty-five patients [mean age 41.0 ± 1.9 years; 33 (73.3%) males] were studied. In 14 (31.1%) of the patients there was a clinical response of knee synovitis, while the remaining 31 (68.9%) patients were non-responders. Response to DMARD therapy was associated with disease subtype (p = 0.011) and HLA-B27 (p = 0.023) but not with a history of psoriasis (p = 0.067) or age at disease onset (p = 0.054). However, only a history of psoriasis could independently predict the response to DMARDs [adjusted odds ratio (OR) 0.232, p = 0.049]. CONCLUSIONS: One-third of the patients with peripheral SpA and severe resistant knee synovitis had a clinical response to DMARD therapy. Disease subtype and HLA-B27 were associated with the response of knee synovitis to DMARDs, but only psoriasis could independently predict this response.

Calcitonin delays the progress of early-stage mechanically induced osteoarthritis. In vivo, prospective study.

BACKGROUND/RATIONALE: Introducing new or testing existing drugs in an attempt to modify the progress of osteoarthritis (OA) is of paramount importance. QUESTIONS/PURPOSES: This study aims to determine the effect exerted by Calcitonin on the progress of early-stage osteoarthritic lesions. METHODS: We used 18, skeletally mature, white, female, New Zealand rabbits. OA was operatively induced in the right knee of each animal by the complete dissection of the anterior cruciate ligament, complete medial meniscectomy and partial dissection of the medial collateral ligament. Postoperatively, animals were divided into two groups. Starting on the ninth postoperative day and daily thereafter, group A animals (n = 9) received 10 IU oculus dexter (o.d.) of synthetic Calcitonin IntraMuscularly (I.M.); group B animals (n = 9) received equal volume of saline o.d. Three animals from each group were sacrificed at 1, 2 and 3 months following treatment's initiation. The extent and the grade of OA were assessed macroscopically, histologically and by radiographs, Computed Tomography (CT) and Magnetic Resonance Imaging (MRI)-scans. The Osteoarthritis Research Society International (OARSI) score, incorporating histological and macroscopic information, was calculated for each knee. RESULTS: Osteoarthritic changes in group A animals were less severe and progressed less rapidly when compared with those of group B animals (sham). This difference was statistically significant in the first and second month (P = 0.05), but not in the third month (P = 0.513). CONCLUSIONS: I.M. administration of Calcitonin seems to delay the progress of early-stage osteoarthritic lesions induced by mechanical instability in a rabbit experimental model.

Reliability and concurrent validity of the adapted Greek version of the Scoliosis Research Society-22r Questionnaire. A cross-sectional study performed on conservatively treated patients.

BACKGROUND: The Scoliosis Research Society-22r Questionnaire (SRS-22r) is a questionnaire assessing the health related quality of life of patients with scoliosis. Aim of this study was to evaluate the validity and reliability of the Greek Version of the SRS-22r in patients suffering from scoliosis who were treated conservatively. METHODS: The (translated and adapted) Greek versions of the SRS-22r together with the previously validated Short Form-36 questionnaire were mailed to 117 patients suffering from idiopathic scoliosis. Two weeks later, the Greek SRS-22r was mailed to the same patients once again. The internal consistency, reproducibility and concurrent validity were assessed. RESULTS: Factor analysis revealed a five-factor structure. The study demonstrated high Cronbach α coefficients for all but the 'Satisfaction with management' domain, when compared with the original questionnaire. Intraclass correlation was excellent regarding every domain of the SRS-22r. Concerning concurrent validity, one domain had excellent (r=0.75-1), thirteen domains good (r=0.50-0.75) and 16 domains moderate correlations (r=0.25-0.50) when compared with the relevant domains of the SF-36 questionnaire. CONCLUSIONS: This Greek Version of the SRS-22r outcome instrument is a validated questionnaire which can be used to evaluate Greek-speaking patients suffering from Idiopathic Scoliosis who are being treated conservatively.

Exercise-induced rhabdomyolysis from stationary biking: a case report.

There are several reports concerning exercise and rabdomyolysis. There has been no report in the English literature of exercise induced rabdomyolisis from a stationary bike.A 63-year-old female recreational athlete presented to our hospital seeking treatment for lower back, leg pain and stiffness after exercising on a stationary bicycle one day prior. Blood work showed a raised CK of 38,120 U/L, a myoglobin of 5330 and an AST 495 U/L with normal urea and electrolytes. Urinalysis remained negative. She was admitted for oral and intravenous hydration and fluid balance monitoringThis is a very rare case of rhabdomyolysis due to exercise. This study highlights the difficulties faced by accident and emergency teams in distinguishing delayed onset muscle soreness (DOMS) from exercise-induced rhabdomyolysis, and reinforces the concept that rhabdomyolysis can occur at any level of exercise intensity.

Simultaneous bilateral fracture-dislocation of the talus: a case report.

A bilateral talar body fracture-dislocation in a 29-year-old multitrauma patient is presented. There was a comminuted fracture associated with an ankle, subtalar and talonavicular subluxation on the right lower limb and an open fracture with complete dislocation of the body of talus on the left side. We performed a minimal invasive reduction and stabilization of the fractures with the use of K-wires, due to severe contamination of the wounds and the patient's poor general condition. After a 28-month follow-up there were signs of posttraumatic arthritis but no signs of avascular necrosis of the talus bilaterally. The range of motion in both ankle joints was limited but the patient had a satisfactory level of activity.

Inferior dislocation of the proximal tibiofibular joint: a new type of dislocation with poor prognosis.

Dislocation of the proximal tibiofibular joint is an unusual injury. We report a patient, who developed inferior proximal tibiofibular dislocation after a severe motorcycle accident. The dislocation was associated with avulsion of the leg, fractures of the fibula and the ankle and neurovascular lesions. The patient was surgically treated and had a good final outcome. Classifications of proximal tibiofibular dislocations did not include inferior dislocation. This type is always associated with avulsion mechanism and has the poorest prognosis.

Idiopathic scoliosis: a transcranial magnetic stimulation study.

STUDY DESIGN: Various neurophysiological parameters of the motor system were investigated in 43 female patients with Idiopathic Scoliosis (IS) and 31 sex and age matched controls using transcranial magnetic stimulation (TMS). OBJECTIVE: To investigate whether asymmetries in excitatory and inhibitory brain processes, as studied by TMS, are a causative factor in IS. SUMMARY OF BACKGROUND DATA: Previous studies associated IS with pathological asymmetries of the cerebral cortex and the brain stem at the level of the corticospinal tracts. METHODS: Forty-three female patients with right IS and 31 normal female subjects entered the study. Various TMS parameters, including the study of ipsilateral pyramidal tract, were studied. Electrophysiological data were correlated with clinical data, the degrees of the scoliotic curve and the Perdriolle and Nash & Moe indexes. RESULTS: In upper limbs, detailed testing failed to reveal any statistically significant differences between the patient and the control group. In lower limbs, side-to-side differences of central motor conduction time (CMCT) and facilitated cortical-to-muscle latencies were increased in the scoliotic patients (p<0.05). This finding correlated significantly with Nash & Moe and Perdriolle indexes (Spearman's r=0.406 and 0.575, respectively, p<0.05). Following the Bonferroni adjustment, however, differences in CMCT SSDs were not statistically significant (p>0.05). CONCLUSION: The present TMS data do not support the concept of a generalized brain asymmetry in IS. In lower limbs, a trend towards increased asymmetries in side-to-side differences of CMCT and cortical latencies was detected probably representing subclinical involvement of the corticospinal tracts secondary to mechanical compression. Finally, it is concluded that non-decussation of the pyramidal tracts is not involved in the pathogenesis of IS.

The role of the dorsal vertebral cortex in the stability of transpedicular screws. A biomechanical study in human cadaveric vertebrae.

The aim of this biomechanical study was to investigate the role of the dorsal vertebral cortex in transpedicular screw fixation. Moss transpedicular screws were introduced into both pedicles of each vertebra in 25 human cadaver vertebrae. The dorsal vertebral cortex and subcortical bone corresponding to the entrance site of the screw were removed on one side and preserved on the other. Biomechanical testing showed that the mean peak pull-out strength for the inserted screws, following removal of the dorsal cortex, was 956.16 N. If the dorsal cortex was preserved, the mean peak pullout strength was 1295.64 N. The mean increase was 339.48 N (26.13%; p = 0.033). The bone mineral density correlated positively with peak pull-out strength. Preservation of the dorsal vertebral cortex at the site of insertion of the screw offers a significant increase in peak pull-out strength. This may result from engagement by the final screw threads in the denser bone of the dorsal cortex and the underlying subcortical area. Every effort should be made to preserve the dorsal vertebral cortex during insertion of transpedicular screws.

Brachial plexus palsy secondary to birth injuries.

We describe the long-term results in ten patients with obstetric brachial plexus palsy of anterior shoulder release combined with transfer of teres major and latissimus dorsi posteriorly and laterally to allow them to act as external rotators. Eight patients had a lesion of the superior trunk and two some involvement of the entire brachial plexus. The mean age at operation was six years, and the mean follow-up was 30 years. Before operation, the patients were unable actively to rotate the arm externally beyond neutral, although this movement was passively normal. All showed decreased strength of the external rotator, but had normal strength of the internal rotator muscles. Radiologically, no severe bony changes were seen in the glenohumeral joint. No clinically detectable improvement of active abduction was noted in any patient. The mean active external rotation after operation was 36.5 degrees. This was maintained for a mean of ten years, and then deteriorated in eight patients. At the latest follow-up the mean active external rotation was 10.5 degrees. The early satisfactory results of the procedure were not maintained. In the long term there was loss of active external rotation, possibly because of gradual degeneration of the transferred muscles, contracture of the surrounding soft tissues and degenerative changes in the glenohumeral joint.

Loading simulation of lumbar spine vertebrae during a compression test using the finite elements method and trabecular bone strength properties, determined by means of nanoindentations.

The mechanical strength properties of lumbar spine vertebrae are of great importance in a wide range of applications. Herein, through nanoindentations and appropriate evaluation of the corresponding results, trabecular bone struts stress-strain characteristics can be determined. In the frame of the present paper, an L2 fresh cadaveric vertebra, from which posterior elements were removed, was subjected to compression. With the aid of developed finite elements method based algorithms, the cortical shell and the cancellous core bulk elasticity moduli and stresses were determined, whereas the tested vertebra geometrical model used in these algorithms was considered as having a compound structure, consisting of the cancellous bone surrounded by the cortical shell. Moreover nanoindentations were conducted and an appropriate evaluation method of the obtained results was applied to extract stress-strain curves of individual lumbar spine vertebra trabecular bone struts. These data were used in the mathematical description of the vertebrae compression test. The vertebral cancellous bone structure was simulated by a beam elements network, possessing an equivalent porosity and different stiffnesses in vertical and horizontal direction. Thus, the measured course of the compression load versus the occurring specimen deformation was verified.

The pathogenetic influence of I-parathyroid hormone on slipped capital femoral epiphysis. Towards a new etiologic approach?

The displacement of the femoral head along the upper femoral physis that occurs during adolescence or slipped capital femoral epiphysis (SCFE) is not a very common traumatic entity. Ever since Muller1 first described it in 1888, its symptoms, clinical manifestations, diagnosis, treatment and complications have been thoroughly described and studied. Nevertheless little progress has been accomplished as far as its etiology is concerned. In order to assess the potential pathologic influence of any parathyroid hormone (PTH) disturbances on the development of SCFE, we conducted a prospective clinical study with 14 patients, 7 boys and 7 girls (16 hips), suffering from SCFE (Group A). Another 5 patients who had been treated for SCFE a few years before the study, were used as a control group (Group B). We measured the level of I-PTH along with serum calcium (Ca) and phosphorus (P) levels. Furthermore, we checked all the necessary anthropometric characteristics of the patients (i.e., age, height, weight and sexual maturation). Each patient of Group A was categorized from grade I to grade V according to the progress of the slipping. The results showed an increased incidence of serum PTH level abnormalities (both decrease and increase) in Group A while Group B patients had normal results. The detected I-PTH serum level abnormalities were not in any pattern related to the Ca and P serum levels. We believe that a temporary parathyroid hormone disorder during the early years of adolescence may play a potentially significant role (along with other etiologic factors) in the development of SCFE.

Is the labyrinthine dysfunction a causative factor in idiopathic scoliosis?

The cause of idiopathic scoliosis remains unknown, although research has possibly eliminated some hypothetical causes. Recent reports associating scoliosis convexity with equilibrium control central processing and motor lateralization have suggested that idiopathic scoliosis is connected causally with the motor cortex. In order to analyze these factors a study of labyrinthine function was carried out. This study included seventeen female patients 12 to 14 years old (mean age= 13.36y) with right thoracic idiopathic scoliosis and twelve normal control females 12 to 14 years old (mean age =13.1y). An electro-nystagmographic study of labyrinthine function (potential nystagmus) was performed in all the patients of the study with caloric tests. The nystagmus was recorded with the electronystagmographic technique (ENG) using Hartmann device. We evaluate these parameters: Slow phase velocity (SPV), Total amplitude (Tamp), Frequency of nystagmus (Freq). No children of the study presented spontaneous nystagmus. No correlation was found between the convexity of the curvature and the direction of nystagmus in posture tests. There were no significant differences between left- and right- beating nystagmus. The results are discussed with special reference to aetiology in idiopathic scoliosis.

Is the central nervous system a causative factor in idiopathic scoliosis?

The present study was designed to investigate the involvement of central nervous system (CNS) in the pathogenesis of idiopathic scoliosis. Seventeen female patients with right thoracic idiopathic scoliosis (mean age = 13.36y) and ten normal controls (mean age =12.6y) entered the study. Magnetic stimulation of the brain was performed. Threshold measurements included upper (UT) and lower threshold (LT). Cortical latencies of MEPs during muscle activation were also measured.

Comparative study between Wilson and Mitchell metatarsal osteotomies for the treatment of hallux valgus in adults.

Although Mitchell osteotomy and Wilson osteotomy are two popular methods for the treatment of hallux valgus, there are no studies directly comparing their results. Fifty-six patients (73 feet) who underwent a Wilson osteotomy and 30 patients (34 feet) who had a Mitchell osteotomy were followed for a mean period of 33.7 and 38.9 months, respectively. The results were comparable in terms of hallux valgus angle correction and first intermetatarsal angle correction, although symptomatic improvement was higher in the Mitchell group. Moreover, the incidence of postoperative metatarsalgia was significantly lower in the Mitchell group as compared to the Wilson group (11.8% vs 32.9%), while less time was required for the patients who underwent Mitchell osteotomy to return to work or normal activities postoperatively. The difference in symptomatic improvement, incidence of postoperative metatarsalgia and rehabilitation time was even more clearly in favor of the Mitchell group in patients over 55. The increased stability at the osteotomy site offered by the Mitchell osteotomy compared to Wilson osteotomy could be the reason why patients had a lower incidence of postoperative metatarsalgia and returned to their normal activities faster, thus giving a higher satisfaction rate.

Segmental spinal correction of idiopathic scoliosis. Luque rods and Hartshill rectangle in 30 patients followed for 2-6 years.

30 patients with idiopathic scoliosis were treated by posterior spinal arthrodesis using the Luque (8 patients) and Hartshill (22 patients) rodding systems with sublaminar segmental wiring. Patients were followed for 2 to 6 years. In most cases, postoperative correction exceeded safety correction limits (lateral bending film plus 10 degrees). Final correction was 55%, while derotation was not significant (average 3 degrees). No neurological deficit was noted. Postoperative bracing was not applied and there was 1 patient with broken rods (Luque trolley system without fusion) and 1 patient with broken wires in 4 segments. Allogenic blood transfusion was avoided in 19 patients by preoperative donation of autologous blood, in combination with salvage of intraoperative shed blood. We found segmental spinal wiring with either rods or rectangles to be a safe method for correction of scoliosis in experienced hands. It offered satisfactory stability and fusion rate with no need for external support.