Effectiveness, safety, and cost-utility of a knee brace in medial knee osteoarthritis: the ERGONOMIE randomized controlled trial.

OBJECTIVE: This pragmatic, multicenter, open-label, randomized controlled trial (RCT) aimed to compare the effectiveness, safety, and cost-utility of a custom-made knee brace versus usual care over 1 year in medial knee osteoarthritis (OA). DESIGN: 120 patients with medial knee OA (VAS pain at rest >40/100), classified as Kellgren-Lawrence grade II-IV, were randomized into two groups: ODRA plus usual care (ODRA group) and usual care alone (UCA group). The primary effectiveness outcome was the change in VAS pain between M0 and M12. Secondary outcomes included changes over 1 year in KOOS (function) and OAKHQOL (quality of life) scores. Drug consumption, compliance, safety of the knee brace, and cost-utility over 1 year were also assessed. RESULTS: The ODRA group was associated with a higher improvement in: VAS pain (adjusted mean difference of -11.8; 95% CI: -21.1 to -2.5); all KOOS subscales (pain: +8.8; 95% CI: 1.4-16.2); other symptoms (+10.4; 95% CI: 2.7-18); function in activities of daily living (+9.2; 95% CI: 1.1-17.2); function in sports and leisure (+12.3; 95% CI: 4.3-20.3); quality of life (+9.9; 95% CI: 0.9-15.9), OAKHQOL subscales (pain: +14.8; 95% CI: 5.0-24.6); and physical activities (+8.2; 95% CI: 0.6-15.8), and with a significant decrease in analgesics consumption at M12 compared with the UCA group. Despite localized side-effects, observance was good at M12 (median: 5.3 h/day). The ODRA group had a more than 85% chance of being cost-effective for a willingness-to-pay threshold of €45 000 per QALY. CONCLUSIONS: The ERGONOMIE RCT demonstrated significant clinical benefits of an unloader custom-made knee brace in terms of improvements in pain, function, and some aspects of quality of life over 1 year in medial knee OA, as well as its potential cost-utility from a societal perspective.

Clinical effectiveness and safety of a distraction-rotation knee brace for medial knee osteoarthritis.

OBJECTIVE: Evaluation of the clinical effectiveness and safety of a new custom-made valgus knee brace (OdrA) in medial knee osteoarthritis (OA) in terms of pain and secondary symptoms. METHODS: Open-label prospective study of patients with symptomatic medial knee OA with clinical evaluation at 6 and 52 weeks (W6, W52). We systematically assessed pain on a visual analog scale (VAS), Knee injury and Osteoarthritis Outcome Score (KOOS), spatio-temporal gait variables, use of nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesic-sparing effects of the brace and tolerance. Mean scores were compared at baseline, W6 and W52 and the effect size (ES) and 95% confidence intervals (95% CIs) were calculated. RESULTS: We included 20 patients with knee OA (mean age 64.2±10.2 years, mean body mass index 27.2±5.4 kg/m2). VAS pain and KOOS were improved at W6 and W52: pain (ES=0.9 at 1 year), amelioration of other symptoms (ES=0.4), and function in activities of daily living (ES=1.1), sports and leisure (ES=1.5), quality of life (ES=0.9) and gait speed (ES=0.41). In total, 76% of patients showed clinical improvement at 1 year. Analgesic and NSAIDs consumption was significantly decreased at W6 and W52. One serious adverse effect noted was lower-limb varices, and observance was deemed satisfactory at 1 year. CONCLUSION: This new unloader brace appeared to have good effect on medial knee OA, with an acceptable safety profile and good patient compliance.

A classification study of kinematic gait trajectories in hip osteoarthritis.

The clinical evaluation of patients in hip osteoarthritis is often done using patient questionnaires. While this provides important information it is also necessary to continue developing objective measures. In this work we further investigate the studies concerning the use of 3D gait analysis to attain this goal. The gait analysis was associated with machine learning methods in order to provide a direct measure of patient control gait discrimination. The applied machine learning method was the support vector machine (SVM). Applying the SVM on all the measured kinematic trajectories, we were able to classify individual patient and control gait cycles with a mean success rate of 88%. With the use of an ROC curve to establish the threshold number of cycles necessary for a subject to be identified as a patient, this allowed for an accuracy of higher than 90% for discriminating patient and control subjects. We then went on to determine the importance of each trajectory. By ranking the capacity of each trajectory for this discrimination, we provided a guide on their order of importance in evaluating patient severity. In order to be clinically relevant, any measure of patient deficit must be compared with clinically validated scores of functional disability. In the case of hip osteoarthritis (OA), the WOMAC scores are currently one of the most widely accepted clinical scores for quantifying OA severity. The kinematic trajectories that provided the best patient-control discrimination with the SVM were found to correlate well but imperfectly with the WOMAC scores, hence indicating the presence of complementary information in the two.

Eccentric training in chronic heart failure: feasibility and functional effects. Results of a comparative study.

OBJECTIVES: To evaluate, in chronic heart failure (CHF) patients, feasibility, safety, compliance and functional improvements of an eccentric (ECC) cycle training protocol personalized by the rate of perceived exertion (RPE; 9-11 Borg Scale), compared to concentric (CON) training at workload corresponding to the first ventilatory threshold. METHODS: Thirty patients were randomly allocated to ECC or CON training (20 sessions). Compliance was evaluated with RPE, visual analog scale for muscle soreness and monitoring of heart rate (HR). Functional parameters were measured by the distance walked and the VO(2) uptake during the 6-minute walk test (6MWT) before and after training. RESULTS: Two patients were excluded due to adverse effects in each group. RPE was 9-11 in ECC training while it reached 12-14 in CON training. HR remained stable in ECC group during exercise whereas it increased during CON exercise. 6MWT distance improved in both group (ECC: +53 m; CON: +33 m). 6MWT VO(2) uptake remained stable in ECC group whereas it increased in CON group. CONCLUSION: ECC training tailored by RPE appears to be an efficient and safe alternative for CHF patients. Indeed, it induces functional improvement similar to conventional CON training with lower demand on the cardiovascular system during exercise.

Test-retest reliability of 3D kinematic gait variables in hip osteoarthritis patients.

OBJECTIVES: (1) to investigate the test-retest reliability of 3D gait analysis (3DGA) in hip Osteoarthritis (OA) patients; (2) to find the minimum number of gait trials needed to overcome intrinsic variability; (3) to check the accuracy of angles measured by the 3D system. DESIGN: 23 Patients suffering from hip OA with no other major disease were recruited. We evaluated the reliability of spatio-temporal variables and body angles (lower-limb joints, trunk and pelvis angles) during two sessions of 3DGA using intra-class correlation coefficients (ICC). The minimum number of trials needed to overcome intrinsic variability was evaluated using an exponential fit model and the Bland and Altman coefficient of repeatability (CoR). The accuracy of measurement was evaluated using a manual goniometer and the recording of 18 different angles. RESULTS: Spatio-temporal variables and most of the kinematic joint and trunk angles calculated demonstrated good to excellent reliability (ICC from 0.77 to 0.97). This was not the case for pelvic angles. The fitting model combined with the CoR showed that 5-10 trials are sufficient to obtain good reliability [ICC>0.7; CoR<2 standard deviation (SD)] for most of the spatio-temporal variables. All body angles showed good reliability (ICC>0.7) and low CoR (<2 SD) after five trials except for the pelvic angles. The reliability of marker positioning was found to be good (ICC>0.7) to excellent (ICC>0.9). Differences between angles measured using 3DGA and angles measured with a manual goniometer were found to be less than one percent. CONCLUSION: The present study shows that most of variables obtained using 3DGA in hip OA patients are reliable. Moreover, for most variables, 5-10 trials are needed to obtain good reliability and to overcome intrinsic variability, rather than 30 or more, thus improving the feasibility of measurement.

[Implementation of quality assurance program ISO 9001 in a department of paediatric oncology]. / Mise en place d'un système d'assurance qualité ISO 9001 en cancérologie pédiatrique.

OBJECTIVE: Our objective was to improve the organization and management of care facilities for children suffering from cancer or leukaemia and to be aligned with the legislation in force in France. METHODS: Our report is on the successive steps for the implementation of a quality assurance system, methods used, motivations, cost, difficulties encountered as well as the advantages obtained. In the Regional Centre for Paediatric Oncology (CRCP) at the CHU in Clermont-Ferrand, we launched a quality programme based on ISO9001/2000 standards. The implementation of the quality assurance system was conducted as a research project and an established medical project with the support of the Management Team. The mission was divided into several "processes", an approach consisting of considering the clinical service in terms of flow and successions of transformations (reception, care, support, accompaniment, etc.) which produce added-value (services and products adapted to the needs of the "customers": children, families, correspondents). RESULTS: We singled out ten physical processes or "job specializations" such as "diagnosis", "care" or "project for the child". The cartography which is the systematic representation of the processes and the interactions between them made it possible to draw up a global vision of the CRCP "care" activity. CONCLUSION: The ISO9001/2000 standard is a tool designed to help organization and management. The benefit obtained in implementing it in a clinic was perceived in organisational terms and lead to a true team spirit, a standardization of the professional practices and the enhancement of the role of each person. The advantages appear at three levels: the child and his/her family, the medical and paramedical teams, and the administrative supervisory bodies.

Routine cryopreservation of kiwifruit (Actinidia spp) germplasm by encapsulation-dehydration: importance of plant growth regulators.

The encapsulation-dehydration protocol was optimized for an in vitro cultured hybrid Actinidia arguta x A. deliciosa. Shoot tips from 14-d reactivated mononodal microcuttings were embedded, transferred to liquid culture medium whose sucrose concentration was daily increased (0.3, 0.5, 0.75 M) and then kept at 0.75 M for 2 or 4 d. Dehydration on silica gel was monitored to 20+/-1.5% residual water content (dry weight basis), allowing direct quenching in liquid nitrogen and rewarming at room temperature. Differential scanning calorimetry analysis underlined the importance of reversible glass transition in shoots for survival. Regrowth ranged from 85% to 95%. Growing shoot tips showed no phenotypic abnormalities. Rooting was also achieved. This method was routinely applied to diploid A. chinensis and A. eriantha, and to several diploid hybrids, yielding over 70% regrowth. A slight decrease in sucrose molarity (0.65 M) allowed tetraploid A. chinensis and A. chrysantha x A. arguta to survive dehydration, but not quenching in LN. For A. deliciosa cv Hayward and cv Tomuri, normal regrowth after cryopreservation was achieved only after modification of the pre- and post-culture media, highlighting the importance of monitoring plant growth regulator balance, principally at the post-thaw recovery step.

The validity of a parent report instrument of child language at twenty months.

When carefully assessed and analysed, parent report can provide a valuable overall evaluation of children's language at 20 months. Norming information and validity coefficients are presented here for a vocabulary checklist assessment included in the Early Language Inventory. Normative data are provided for fullterm, preterm, and precocious samples, including selected vocabulatory subsets that are indicative of early language learning style. The vocabulary checklist has substantial validity as indexed by correlations with the Bayley Scales of Infant Development and particularly with a language subscale derived from that test.