Elettra Pignotti

Data management in gait analysis for clinical applications

OBJECTIVE: To study the reliability of gait analysis data obtained using the Calibrated Anatomical System Technique (CAST) protocol and to verify the suitability and repeatability of the extraction of a number of parameters from the waveforms obtained. DESIGN: The experimental protocol and the parametric analysis technique were applied on a population of able-bodied subjects. BACKGROUND: The clinical interpretation process of gait data still needs a more accurate analysis of the reliability and repeatability of the measurements and a suitable procedure for data reduction useful for data comparison. METHODS: Gait analysis was performed in 20 able-bodied subjects using a stereophotogrammetric system and a forceplate. 124 parameters relative to time-distance, kinematic and kinetic variables were calculated by means of an automatic procedure and statistically analysed. RESULTS: Most of the parameters were found to be normally distributed with relatively small range of variation. Few of them showed poor repeatability, mostly due to the experimental inaccuracies introduced. Correlation of several gait parameters with age, sex, and speed of progression was also identified.

Matrix-Assisted Autologous Chondrocyte Transplantation for the Repair of Cartilage Defects of the Knee Systematic Clinical Data Review and Study Quality Analysis

Background The clinical application of the second-generation tissue-engineering approach for the treatment of cartilage lesions has been documented for different types of scaffolds, but systematic information on clinical efficacy and long-term results is not available. Purpose To analyze and assess the quality of clinical studies on different products in the emerging field of matrix-assisted auto-logous chondrocyte transplantation. The secondary purpose of this review was to improve the quality assessment of studies by modifying the Coleman methodology score (CMS). Study Design Systematic review. Methods For this review, a literature search was performed to identify all published and unpublished clinical studies of matrixassisted (second-generation) autologous chondrocyte transplantation using the following medical electronic databases: MED-LINE, MEDLINE preprints, EMBASE, CINAHL, Life Science Citations, and British National Library of Health, including the Cochrane Central Register of Controlled Trials (CENTRAL). The search period was January 1, 1995, to July 1, 2008. To better assess cartilage-related studies, a modification of the CMS was proposed. Results Eighteen studies were included in the analysis, reporting on 731 patients with an average follow-up of 27.3 months (6.5-60.0 months). Of the 18 studies, 2 were randomized controlled studies, 3 were prospective comparative studies, 11 were prospective cohort studies or prospective case series, and 2 were retrospective case series. Original CMSs for these studies (55.1 6 1.6) were significantly higher than those of cartilage repair studies in general (43.5 6 1.6, P <.0001) reported in 2005. The statistical analysis indicated that the modified CMS showed higher correlations and lower variability of correlations among 3 reviewers. Conclusion The quality of the currently available data on second-generation autologous chondrocyte transplantation is still limited by study designs. The modified CMS has demonstrated better sensitivity and reproducibility with respect to the original score, so it can be recommended for cartilage clinical studies evaluation.

Profiling Tumor-Associated Markers for Early Detection of Malignant Mesothelioma: An Epidemiologic Study

Improved detection methods for diagnosis of asymptomatic malignant mesothelioma (MM) are essential for an early and reliable detection and treatment of this type of neoplastic disease. Thus, focus has been on finding tumor markers in the blood that can be used for noninvasive detection of MM. Ninety-four asbestos-exposed subjects defined at high risk, 22 patients with MM, and 54 healthy subjects were recruited for evaluation of the clinical significance of 8-hydroxy-2′-deoxyguanosine (8OHdG) in WBCs and plasma concentrations of soluble mesothelin-related peptides (SMRPs), angiogenic factors [platelet-derived growth factor β, hepatocyte growth factor, basic fibroblast growth factor, and vascular endothelial growth factor β (VEGFβ)], and matrix proteases [matrix metalloproteinase (MMP) 2, MMP9, tissue inhibitor of metalloproteinase (TIMP) 1, and TIMP2] for potential early detection of MM. The area under receiver operating characteristic (ROC) curves indicate that 8OHdG levels can discriminate asbestos-exposed subjects from healthy controls but not from MM patients. Significant area under ROC curve values were found for SMRPs, discriminating asbestos-exposed subjects from MM patients but not from healthy controls. Except for platelet-derived growth factor β, the hepatocyte growth factor, basic fibroblast growth factor, and VEGFβ can significantly differentiate high-risk individuals from healthy control and cancer groups. No diagnostic value was observed for MMP2, MMP9, TIMP1, and TIMP2. In addition to the diagnostic performance defined by the ROC analysis, the sensitivity and specificity results of markers with clinical significance were calculated at defined cutoffs. The combination of 8OHdG, VEGFβ, and SMRPs best distinguished the individual groups, suggesting a potential indicator of early and advanced MM cancers. The combination of blood biomarkers and radiographic findings could be used to stratify the risk of mesothelioma in asbestos-exposed populations. (Cancer Epidemiol Biomarkers Prev 2008;17(1):163–70)

Second malignant neoplasm in patients with osteosarcoma of the extremities treated with adjuvant and neoadjuvant chemotherapy.

We evaluated the rate of second malignancies in 1205 patients with osteosarcoma of the extremity treated at our Institution with different protocols of adjuvant and neoadjuvant chemotherapy. Twenty-six patients (2.15%) developed a second malignant neoplasm at a median of 7.6 years (1 to 25 y) after primary osteosarcoma treatment. Of these, 2 developed a third cancer which were not considered in the series. Second neoplasms were leukemia (10), breast (7), lung (2), kidney (2), central nervous system cancer (2), soft tissue (1), parotid (1), and colon (1). The rate of second neoplasms was significantly higher in female patients, and the latent period shorter in hematologic tumors compared with solid tumors. Ten of these 26 patients are disease free at a median of 7.7 years (range 1 to 15 y) after the last treatment. The rate of second malignancies observed in the osteosarcoma group was significantly higher than that observed in the control group of 1160 patients with benign tumors treated in the same period at our Institute (2.2% vs. 0.8%, P<0.009). Our study showed that the risk of second neoplasm within 15 years increased and then leveled off and that although secondary solid tumors could be explained as unrelated cases, leukemias seem to be over represented.

Living with rotationplasty—Quality of life in rotationplasty patients from childhood to adulthood

Knowledge about the long‐term sequelae of rotationplasty, in adults treated surgically in childhood for Osteosarcoma in the lower limb, mainly concerns function and performance; the aim of this study is to explore the experience and the Quality of Life (QoL) of the patients who underwent Rotationplasty from 1986 to 2006 in Italy.

Prognostic role of nuclear factor/IB and bone remodeling proteins in metastatic giant cell tumor of bone: A retrospective study

Giant cell tumor of bone (GCTb) represents 5% of bone tumors, and although considered benign, 5% metastasize to the lung. The expression of proteins directly or indirectly associated with osteolysis and tumor growth was studied on 163 samples of GCTb. Of these, 33 patients developed lung metastasis during follow‐up. The impact of tumor–host interaction on clinical aspects was evaluated with the aim of finding specific markers for new biological therapies, thus improving clinical management of GCTb. Protein expression was evaluated by immunohistochemical analysis on Tissue Microarray. The majority of GCTb samples from patients with metastatic disease were strongly positive to RANKL and its receptor RANK as well as to CAII and MMP‐2 and to pro‐survival proteins NFIB and c‐Fos. Kaplan–Meier analysis indicated a significant difference in metastasis free survival curves based on protein staining. Interestingly, the statistical correlation established a strong association between all variables studied with a higher τ coefficient for RANK/RANKL, RANK/NFIB, and RANKL/NFIB pairs. At multivariate analysis co‐overexpression of NFIB, RANK and RANKL significantly increased the risk of metastasis with an odds ratio of 13.59 (95%CI 4.12–44.82; p < 0.0005). In conclusion, the interconnection between matrix remodeling and tumor cell activity may identify tumor–host endpoints for new biological treatments.

Effect of ascorbic acid-rich diet on in vivo-induced oxidative stress.

Using hyperbaric oxygen (HBO) therapy as an in vivo oxidation model, we investigated the effect of a diet enriched in ascorbic acid (AA) on HBO-induced oxidative stress. Volunteers (n 46) were allocated to the AA-rich diet group or the control group. Blood samples were collected at the basal time, after the 1-week diet before and immediately after the HBO treatment, and 1 week after the HBO treatment. AA level, total antioxidant status (TAS), hydroperoxides (HP), lymphocyte DNA oxidation and DNA repair capacity were assessed. The expression of genes involved in oxidative stress was evaluated in lymphocytes and the protein activity of the modulated genes was determined in the plasma. The AA level and the antioxidant status of plasma were increased by AA-rich food consumption. HBO exposure did not affect the AA levels or TAS, but induced HP formation in the control group. The lymphocytes isolated from dietary-supplemented subjects were resistant to ex vivo DNA oxidation, showing an increased DNA repair capacity compared with controls. A difference in gene expression pattern was observed between the groups. AA-rich foods provide dual protection against oxidative stress, enhancing plasma antioxidant levels and stimulating genes involved in cell detoxification.

Use of polyurethane foam inside plaster casts to prevent the onset of heel sores in the population at risk. A controlled clinical study

AIM The aim of this study was to test the effectiveness of polyurethane foam in contact with the heel inside a plaster cast to decrease the rate of pressure sores in the population at most risk. BACKGROUND The rate of pressure sores caused by the plaster cast is reported to be 14-15% in the paediatric population, 33.3% in patients having undergone chemotherapy for bone tumours and 43% in orthopaedic patients who already have sore skin when the cast is applied (grade 1 lesion) to the heel. DESIGN Controlled clinical trial. METHODS From November 2007-January 2009, all consecutive subjects requiring lower limb casts having undergone chemotherapy and/or presenting heel soreness received polyurethane foam in contact with the skin of the heel before applying the cast. The results were compared with those of patients with the same risk factors but were not administered the foam and were enrolled from May 2005-August 2006. RESULTS In total, 156 patients were enrolled, 85 in the control group and 71 in the experimental group. In the experimental group, 2 of the 56 patients (3.6%) with sore skin developed a pressure sore compared with 21 of 49 (42.9%) in the control group without polyurethane foam (p < 0.0005). In the experimental group, one of the 24 patients (4.2%) patients undergoing chemotherapy developed a pressure sore compared with 18 of 54 (33.3%) in the control group (p = 0.005). CONCLUSIONS Placing polyurethane foam in contact with the skin of the heel inside a plaster cast prevents the formation of pressure sores. RELEVANCE TO CLINICAL PRACTICE This study provides evidence that using polyurethane foam to prevent sores even inside plaster casts in populations at most risk is a simple and cost-effective strategy and decreases the discomfort, pain and risks in these patients.

Efficacia della medicazione sterile trasparente rispetto a quella standard per il fissaggio del catetere venoso periferico (CVP) sull'incidenza delle flebiti. Trial randomizzato e controllato

UNLABELLED: Effectiveness of the transparent sterile dressing vs standard to fix the peripheral venous catheter (PVC), on the incidence of phlebitis. A randomized controlled trial. INTRODUCTION: The type of dressing could contribute to the incidence of phlebitis, infiltration and accidental removals but the results of the studies are contrasting and samples are limited. AIM: To compare the effectiveness of a transparent polyurethane sterile dressing on the rate of phlebitis associated to peripheral venous catheter (PVC) vs a non sterile sticking plaster in use in current practice (standard dressing). DESIGN: Randomized controlled trial. Participants. 1061 PVCs (703 patients, adults and children) at a research orthopedic hospital in the north of Italy; 540 PVCs allocated to receive the sterile and 521 the standard dressing. RESULTS: 96 PVCs were excluded for phlebitis, 48 (9.6%) in the sterile and 48 (10.1%) in the standard dressing group, RR 0.96 (95%CI 0.697 - 1.335). Accidental removal of the PVCs was more frequent with the sterile dressing (9.6% vs 6.3%) but the number of catheters removed without complications was larger in the standard dressing group (48.9% vs 54.9% P=0.0503). Eighty-five PVCs were replaced for detachment of the dressing (50, 9.2% sterile and 35, 6.7% standard dressing). The cheapest transparent sterile dressing costs 32 cents while the standard 9 cents. CONCLUSIONS: A sticking non sterile plasters is not influential on the rate of phlebitis and ensures an good fix of the PVC compared the transparent sterile dressing to of polyurethane film.

Rehabilitation Complexity Scale: Italian translation and transcultural validation

Abstract Purpose: The aim of the present study was translation, cultural adaption and validation of the extended version 12 of the Rehabilitation Complexity Scale (RCS-E) in a sample of patients with stroke and total hip replacement. Method: The cross-cultural validation required RCS-E forward–backward translation, revision by an expert committee and its application in an Intensive Rehabilitation setting through a retrospective collection of data from clinical records. The evaluation of the psychometric properties was carried out by analyzing the correlations between RCS-E score and other measures (Functional Independence Measure, Braden, Morse, Cumulative Illness Rating Scale) and the assessment of reliability in terms of reproducibility (inter-observer agreement) and repeatability (intra-observer agreement). Results: The backward and forward processes of translation of the scale did not create problems of interpretation of terms. Some adaptation was required for the items nursing (N), medical care (M) and therapeutic intensity (TI) due to differences on the national health system structure. The Italian version of the scale proved to be valid, reliable with high reproducibility and repeatability. Conclusions: The Italian version RCS-E has been successfully validated, showing good psychometric properties, which partly reproduce the results obtained for the original version. However, some assumption was made for some items thus preventing possible comparison with other countries. Implications for Rehabilitation Admittance at an Intensive Rehabilitation care setting in Italy requires to evaluate the complexity of rehabilitation needs. The Rehabilitation Complexity Scale (RCS-E) has proved to be reliable for assessing clinical complexity and consequently for planning rehabilitation needs. The Italian version of RCS-E has been successfully validated, showing good psychometric properties, which reproduce the results obtained for the original version. The items included in the therapy intensity subscale do not fit the Italian health system rules for intensity of rehabilitation care and needs adaptation.