Functional evaluation of a novel fibreglass-reinforced polyamide custom dynamic AFO for foot drop patients: A pilot study.

BACKGROUND: Ankle-foot orthoses (AFOs) are orthopaedic devices often prescribed to treat foot drop. For patients who are not satisfied with off-the-shelf solutions, custom AFOs personalized to the patient's lower limb anatomy are required. Dynamic AFOs provide stability while allowing for physiological ankle mobility in the stance phase of walking. RESEARCH QUESTION: Can a morphology-based dynamic custom AFO made of fiberglass-reinforced polyamide restore a quasi-normal gait pattern and improve comfort in patients with foot drop? METHODS: In this pilot study, the legs and feet of ten foot drop patients (age=64.9 ± 11.4 years; BMI=26.2 ± 2.1 kg/m2) were scanned using a Kinect-based 3D scanner. A custom AFO was designed and produced for each patient using a fiberglass-reinforced polyamide through selective laser sintering. To assess kinematics, skin markers were placed on relevant bony landmarks according to a validated protocol. Each patient was instructed to walk at a self-selected comfortable speed under three conditions: wearing the custom AFO, wearing an off-the-shelf orthosis (Codivilla spring), and without any AFO (shod condition). Muscle activation in the tibialis anterior, gastrocnemius, rectus femoris and biceps femoris muscles in both legs was recorded using wireless sEMG sensors. The comfort and of each AFO was evaluated using a Visual Analogue Scale. RESULTS: The custom AFO resulted in significant increase of stride length and walking speed compared to the shod condition. Except for the hip joint, which exhibited greater maximum flexion and reduced range of motion, the kinematic parameters of all other joints were similar to those observed in a healthy control population. Furthermore, the custom AFO received significantly higher comfort scores compared to the Codivilla spring. SIGNIFICANCE: This study has provided evidence supporting the effectiveness of custom orthotic solutions in restoring lower limb kinematics and improving the perceived comfort in foot drop patients compared to off-the-shelf solutions.

A novel apparatus to assess the mechanical properties of Ankle-Foot Orthoses: Stiffness analysis of the Codivilla spring.

Ankle-Foot Orthoses (AFOs) are the most common devices prescribed to support the ankle and restore a quasi-normal gait pattern in drop-foot patients. AFO stiffness is possibly the main mechanical property affecting foot and ankle biomechanics. A variety of methods to evaluate this property have been reported, however no standard procedure has been validated and widely used. This study is reporting the repeatability of a novel apparatus to measure AFO stiffness in ideal frictionless conditions. The apparatus is based on a servo-hydraulic testing machine and allows to apply a displacement-controlled rotation of the AFO shell, simulating the physiological ankle dorsi/plantarflexion movement. The repeatability of the apparatus in measuring AFO stiffness in dorsiflexion and plantarflexion was assessed intra- and inter-session in a sample of standard polypropylene AFOs of different sizes (Codivilla spring). The repeatability of the apparatus in measuring the AFO stiffness was high. The Intra- and Inter-session Coefficient of Variation ranged between 0.02 ÷ 1.3 % and 1.3 ÷ 5 %, respectively. The Intra Class Correlation Coefficient ranged between 0.999 ÷ 1 intra- and 0.993 ÷ 0.997 inter-session. AFOs stiffness was observed to increase with the AFO size. The setup is easy to replicate and can be implemented with any torsion-controlled servo-hydraulic testing machine and has resulted simple to use and flexible enough to adapt to AFOs with different sizes. The frictionless contacts characterizing the apparatus make it possible to measure the ideal AFO stiffness by excluding the effect of the fixation methods to the leg and help to improve the repeatability of measurements.

In vitro gene and chromosome characterization of expanded bone marrow mesenchymal stem cells for musculo-skeletal applications.

OBJECTIVE: A number of studies have shown the role of expanded Bone Marrow-derived Mesenchymal Stem Cells in the repair and regeneration of musculo-skeletal tissues. The current European regulations define in vitro expanded cells for clinical purposes as substantially manipulated and include them in the class of Advanced-Therapy Medicinal Products to be manufactured in compliance with current Good Manufacturing Practice. Among the characteristics that such cells should display, genomic stability has recently become a major safety concern. The aim of this study is to perform a chromosomal and genetic characterization of Bone Marrow-derived Mesenchymal Stem Cells expanded in compliance with Good Manufacturing Practice for a potential clinical use in orthopaedics. MATERIALS AND METHODS: Mesenchymal Stem Cells, isolated from bone marrow, were expanded for six weeks in compliance with current Good Manufacturing Practice. DNA profiling analyses were applied to test cross-contamination absence. Genomic stability was evaluated by means of karyotyping, sequencing of TP53, p21/CDKN1A and MDM2 genes and the expression analysis of c-MYC and H-RAS oncogenes, p21/CDKN1A, TP53, p16/CDKN2A, RB1 and p27/CDKN1B tumor suppressor genes and hTERT gene. RESULTS: The DNA profiling analysis showed a unique genetic profile for each Mesenchymal Stem Cell culture, indicating the absence of cross-contamination. Karyotyping evidentiated some chromosomal abnormalities within the 10% limit set by the Cell Products Working Party review, except for one patient. In all cases, the molecular biology analyses did not revealed DNA point mutations, acquisition or changes in gene expression. hTERT levels were undetectable. CONCLUSIONS: Cultured Mesenchymal Stem Cells do not seem to be prone to malignant transformation. In fact, although some chromosomal aberrations were found, molecular biology analyses demonstrated that the expansion phase did not induce the acquisition of de novo genetic changes.

Minimally invasive posterior stabilization for treating spinal tuberculosis.

We describe a case of dorsal-lumbar vertebral tuberculosis (Pott's disease) first treated with antibiotic therapy, bed rest, and cast. After 2 months of treatment patient's symptoms worsened. Minimally invasive posterior vertebral stabilization was carried out, with excellent clinic and radiographic results.

Biopsy for suspected spondylodiscitis.

BACKGROUND: Vertebral biopsy is fundamental in determining whether a spinal lesion is of infectious or neoplastic etiology. Accurate diagnosis is critical for proper medical and/or surgical treatment and consequently for the prognosis of the patient. CT-guided percutaneous spinal biopsy (CTSB) may minimize the risk of contamination and complications. AIM: To demonstrate the importance and efficacy of CTSB and subsequent microbiologic/histological examination in the diagnosis of spinal lesions, particularly for those of an infectious nature. MATERIALS AND METHODS: Two series of spinal infection patients. Prospective series of 69 patients (2009-2011), 24 of whom underwent CTSB. Retrospective series of 130 patients (1999-2008), 65 of whom underwent CTSB. All patients had microbiologic and histological testing of biopsy samples, when possible. RESULTS: For the 2009-2011 patient series, histological examination yielded a diagnosis in 81.8% of cases, microbiologic culture and PCR for Mycobacterium tuberculosis in 45.8%. For the 1999-2008 series, histological examination yielded a diagnosis in 69% of cases, culture in 38.5%. Spinal lesions in 4 patients with previous histories of malignancy were assumed to be metastatic and treated with radiation at outside institutions. After biopsy, all were revealed to be spondylodiscitis. CONCLUSIONS: Percutaneous CT-guided needle biopsy is the mainstay of diagnosis for spine lesions of unknown etiology, thus guiding appropriate treatment. Histological diagnosis, when possible, is critical before initiation of therapy and may be helpful in cases where cultures are negative. In the case of a spinal lesion of unknown origin, even in the setting of a previous malignancy, metastasis should not be assumed; infection and new primary lesions should always be considered as part of the differential diagnosis.

Spinal infection multidisciplinary management project (SIMP): from diagnosis to treatment guideline.

Spine infections require a multidisciplinary approach to be treated and solved. A guide line to drive physicians in the deep complexity of such a disease is extremely helpful. SIMP suggests a flow-chart built up on clear concepts such as right and well managed antibiotic therapy, sound stability of the spine, correct and smart use of the standard and functional imaging techniques, such as f18 FDG PET/CT. In 16 months a total of 41 patients have been treated for spondylodiscitis, discitis and vertebral osteomyelitis by our team of physicians and 25 patients have been enrolled in a prospective study whose target is the assessment of the SIMP flow-chart and of every single aspect that characterize it.

Osteoporotic vertebral fractures: a disabling and expensive disease of our century. A minimally invasive surgical technique to reduce the pain, the hospitalization, and restore the function.

BACKGROUND AND OBJECTIVES: Minimally invasive spine surgery has gained a great consent in the treatment of vertebral osteoporotic fractures. We perform a retrospective clinical and radiographic review on 32 consecutive patients (22 female and 10 male) surgically treated for a thoracolumbar osteoporotic fracture (type A) by a minimally invasive system. By this study, we propose to determine the safety and efficacy of an expandable, percutaneous, minimally invasive technique to reduce the disability caused by vertebral osteoporotic fractures. MATERIAL AND METHODS: We retrospectively reviewed 32 patients who were operated on between 2003 and 2004 by means of an innovative technique which employs an expandable system inserted by a minimally invasive approach into the vertebral body. Average age at surgery was 64.8 years (range, 27-82). All patients were mobilized in first post-operative day with no external immobilization and discharged from the Hospital in the second post-operative day. RESULTS AND CONCLUSIONS: This innovative technique which employs an expandable system inserted by a minimally-invasive approach into the vertebral body permits to obtain a double mechanical support for the vertebral plate, to partially reduce the fracture, to mobilize the patient immediately, reducing disability and costs related to the vertebral osteoporotic fractures.

Management of bone metastases.

Bone metastases are only apparently similar lesions, considering the large varieties of istotypes and the spread of the primary tumour. Although these metastases develop early and are not terminal events, they have to be considered as severe complications. When possible, surgical treatment can improve the history of the patient in terms of life expectancy and quality of life. The approach to these lesions should be multidisciplinary in collaboration with oncologists and radiotherapists. In fact the average of survival of these patients has increased in recent years. The evolution of anesthesiological techniques permits surgical treatments that once were considered prohibitive. The application of new adjuvant therapies increases the effectiveness for surgical treatment. Controversy exists over the most appropriate treatment for patients with bone metastatic disease. The purpose was to determine the best sequential process to arrive at the most appropriate treatment considering the individual general conditions and the parameters of the metastases. As the number of treatment options for metastatic bone disease has grown, it has become clear that effective implementation of these treatments can only be achieved by a multidisciplinary approach.

Total knee arthroplasty in patients with poliomyelitis.

We performed a retrospective chart and radiograph review of 10 patients with a history of poliomyelitis involving a limb that subsequently underwent primary total knee arthroplasty between 2000 and 2008. One posterior stabilized (PS), two condylar constrained (CCK), and seven rotating hinge (RHK) prostheses belonging to the same system were implanted. Eight patients were followed for a minimum of 2 years (mean 4.3 years, range 2 to 8.5 years); one patient required revision for prosthesis infection. The last patient was followed for just six months reporting excellent pain relief, and without complications. American Knee Society Score (AKSS) improved postoperatively in all eight patients with at least 2 years follow-up. The improvement was more marked for the knee score, which increased from a mean of 37 points preoperatively (range 20 to 51) to 75.7 points postoperatively (range 50 to 92); for the functional score the mean increase was only 15.8 points, from a mean of 38.5 points (range 20 to 70) to 54.3 points (range 20 to 80) after the intervention. One patient had a recurrence of the recurvatum deformity after implanting a CCK prosthesis. We found that a rotating hinge prosthesis that allowed hyperextension was suitable treatment for patients with knee osteoarthritis and polio as this compensated for loss of quadriceps power.

Minimally invasive percutaneous fixation in the treatment of thoracic and lumbar spine fractures.

We studied 51 patients with 64 fractures of the thoracolumbar and lumbar spine undergoing the surgical treatment by percutaneous trans-pedicular fixation and stabilization with minimally invasive technique. Patient follow-up ranged from 6 to 28 months (mean 14.2 months) and the patients were assessed by clinical and radiographic evaluation. The results show that percutaneous trans-pedicular fixation and stabilization with minimally invasive technique is an adequate and satisfactory procedure to be used in specific type of the thoracolumbar and lumbar spine fractures.

Management of severe ulcerative colitis with the help of high resolution ultrasonography.

OBJECTIVES: The prognosis of attacks of ulcerative colitis is clearly linked to the extent and activity of the disease. The aim of this study was to investigate the value of high resolution ultrasonography in assessing both the extent and activity of severe ulcerative colitis and its response to medical treatment. METHODS: Fifty-seven consecutive patients affected by a severe (32 patients) or moderately severe (25 patients) attack of ulcerative colitis underwent ultrasonographic examination. The ultrasonographic extent of the disease was evaluated in 32 patients by comparing ultrasonography and scintigraphy. RESULTS: Compared with scintigraphy, sensitivity, specificity, and overall accuracy of ultrasonographic extent were 89%, 100%, and 91%, respectively. These results were also confirmed in a subgroup of patients submitted to surgery, comparing ultrasonographic and scintigraphic data versus specimens. Using the ultrasonographic score of activity, it was possible to discriminate severe and moderately severe attacks with a specificity, sensitivity, and diagnostic accuracy of 96%, 90.3%, and 92.9% respectively. A close correlation was also found between ultrasonographic and scintigraphic activity (r = 0.78; p < 0.001). After 10 days of intensive treatment, the ultrasonographic activity significantly decreased in severe and moderate groups (p < 0.001) and in both subgroups of nonoperated patients (p < 0.001) but not in operated patients (p = NS). CONCLUSIONS: High resolution ultrasonography can be useful in assessing both extent and activity of severe ulcerative colitis, in monitoring the patient's condition, and in objectively evaluating the response to medical therapy.

Doppler ultrasonographic evaluation of splanchnic blood flow in coeliac disease.

BACKGROUND: Current knowledge on splanchnic haemodynamics in coeliac disease is limited and incomplete. AIM: To evaluate splanchnic arterial and venous blood flow in coeliac disease. METHODS: In 22 coeliac (13 untreated, nine treated) patients and in nine healthy subjects the following variables were assessed: vessel diameter and mean flow velocity in portal vein, splenic vein, superior mesenteric vein, and superior mesenteric artery. Peak systolic velocity, end diastolic velocity and pulsatility index were also determined in the superior mesenteric artery. Five patients of the untreated group were re-evaluated after nine months on a gluten free diet. RESULTS: Significant differences in haemodynamic variables between the three groups were shown only in the superior mesenteric artery. An increase in both mean flow velocity and end diastolic velocity and a reduction in pulsatility index occurred in untreated patients compared with treated patients (p < 0.002; p < 0.04; p < 0.035) and with healthy controls (p < 0.001; p < 0.025; p < 0.0003). Similar results were obtained for the five patients evaluated before and after treatment (p < 0.03; p < 0.02; p < 0.03), in whom the mean flow velocity in the superior mesenteric vein also decreased after treatment (p < 0.05). No significant differences were noted between treated coeliac patients and healthy controls. CONCLUSIONS: In untreated coeliac disease there is a hyperdynamic mesenteric circulation that decreases after treatment.

The effects of levosulpiride on gastric and gall-bladder emptying in functional dyspepsia.

BACKGROUND: 50% of patients with functional dyspepsia have delayed gastric emptying. Levosulpiride is an orthopramide drug that stimulates gastrointestinal motility. Aim of our study was to evaluate the effect of levosulpiride on symptoms and gastric and gall-bladder emptying, in dyspeptic patients. METHODS: Thirty adult patients, treated for 20 days with levosulpiride (75 mg/day) or placebo, were evaluated in a randomized double-blind study. Symptoms were assessed by a cumulative index and overall intensity (visual analogue line). Gastric and gall-bladder emptying were evaluated by epigastric impedance (liquid meal) and real-time ultrasonography (mixed meal). RESULTS: Levosulpiride, with respect to placebo, accelerated the mean gastric half-emptying time of liquids (P < 0.05), gastric emptying (P < 0.001 at 180 min; P < 0.05 at 240 min), and gall-bladder emptying (P < 0.05 at 60 and 120 min) emptying after a solid-liquid mixed meal. Both the mean cumulative index (P < 0.05) and the overall intensity (P < 0.025) of dyspeptic symptoms were reduced significantly by levosulpiride. CONCLUSIONS: Our results showed that levosulpiride can be usefully employed in patients affected by functional dyspepsia.

Effect of single dose of oral erythromycin on gastric and gallbladder emptying. Simultaneous assessment by ultrasound.

To evaluate the effects of a single oral dose of erythromycin on gastric and gallbladder emptying, 10 volunteers, without a known history of gastrointestinal disease, were investigated. Erythromycin stearate (500 mg) or placebo was given on separate mornings 30 min before a standard solid meal in a randomized, double-blind, crossover study. Gastric and gallbladder emptying rates were simultaneously evaluated by means of real-time ultrasonography. Gastric antral area and gallbladder volume were determined before the meal and 30, 60, 120, 180, 240, and 300 min after commencing eating. Erythromycin, compared to placebo, significantly accelerates and increases the degree of both gastric and gallbladder emptying. As previously reported for intravenous and chronic oral assumption, also a single dose of oral erythromycin is able to accelerate gastric and gallbladder emptying in normal human subjects.

Comparison of scintigraphy with indium-111 leukocyte scan and ultrasonography in assessment of X-ray-demonstrated lesions of Crohn's disease.

The aim of this study was to compare the results obtained with an indium-111 scan with those obtained with less expensive and harmless ultrasonography to evaluate the location and inflammatory activity of Crohn's disease. Thirty-one patients previously studied with x-ray underwent abdominal 111In scans and ultrasonography (US). Sensitivity and specificity of US in detecting lesions seen with 111In scan were 77% and 92.8%, respectively. Sensitivity and specificity of 111In scan in detecting x-ray-defined lesions were 69.2% and 92.7%; the figures for US were 73% and 93.3%, respectively. Considering the evaluation of disease activity, ultrasonographic bowel wall thickness was significantly related to scintigraphic intensity of emission (r = 0.75 P < 0.01). Our experience suggests that US provided information about the location and inflammatory activity of lesions similar to that obtained from 111In scan.

Hepatocellular carcinoma. Prognostic factors and survival analysis in 135 Italian patients.

This is a retrospective study to evaluate the history of hepatocellular carcinoma and find the relationship between clinical, biochemical and ultrasonographic features and survival in Italian patients. In 135 consecutive patients median follow-up was 16 months (range 1-66 months) and median survival from the time of diagnosis was 12 months. Univariate analysis showed that individual variables associated with significantly decreased survival included: absence of therapy, Okuda's Stage III, Child-Pugh's Class C, alpha-fetoprotein greater than 400 ng/ml, presence of symptoms, moderate or severe ascites, tumor involving both lobes, mixed internal echo pattern, and multinodular or massive type. Multiple regression analysis (Cox model) revealed that the mixed internal echo pattern of hepatocellular carcinoma, the presence of moderate or severe ascites and Okuda's Stage III were independent predictors of high risk of death. These data can help in selecting patients whose probability of survival is considered high enough to undergo treatment and may be useful for stratifying patients in randomized controlled trials.

[Effects of bicarbonated-alkaline water (Uliveto) on gastric and gallbladder emptying in normal subjects. Ultrasonic evaluation]. / Effetti di un'acqua bicarbonato-alcalina (Uliveto) sullo svuotamento gastrico e colecistico nel soggetto normale. Valutazione ecotomografica (ETG).

In 10 healthy patients gastric and gallbladder emptying after a standard meal (800 cal, 60% glucides, 20% protides, 20 lipids) associated with 400 ml alkaline bicarbonated water or tap water were evaluated by ultrasonography. An increase of gastric emptying was noted after alkaline bicarbonated water versus tap water with significant differences at 30' (p less than 0.05), 60' (p less than 0.01) and 120' (p less than 0.05). No significant differences exist in final gastric emptying time. Alkaline bicarbonated water induced less intensive gallbladder emptying with statistical difference versus tap water at 60' and 120' from the standard meal (p less than 0.01).