Safety and Predictive Factors of Short-Term Efficacy of a Single Injection of Mannitol-Modified Cross-Linked Hyaluronic Acid in Patients with Trapeziometacarpal Osteoarthritis. Results of a Multicentre Prospective Open-Label Pilot Study (INSTINCT Trial).

PURPOSE: To assess safety and search predictive factors of efficacy of a single intra-articular injection of a mannitol-modified hyaluronic acid (HA) viscosupplement, in patients having trapeziometacarpal (TMC) osteoarthritis (OA). METHODS: Patients with symptomatic TMC OA, not adequately relieved by analgesic therapy and/or by the use of a thumb splint, were included in a 3-month prospective multicentre open-label trial. All underwent plain radiographs with the Kapandji incidences allowing the Dell radiological grade assessment (1-4). Primary end point was the variation between injection (D0) and day 90 (D90) of the thumb pain (11-point Likert scale). Treatment consisted in a single injection of 0.6 to 1 mL of a viscosupplement made of a cross-linked HA combined with mannitol. All injections were performed under imaging guidance. Predictive factors of pain decrease were studied in univariate and multivariate analysis. RESULTS: A total of 122 patients (76% women, mean age 60, mean disease duration 36 months) were included and 120 (98%) were assessed at 3 months. The TMC OA was of Dell's grade 1, 2, 3, and 4 in 23%, 36.8%, 36.8%, and 3.5% of cases, respectively. At D0, the average (SD) pain level was 6.5 ± 1.6 without significant difference between Dell groups (P = .21). At day 90, pain decreased from 6.5 ± 1.6 to 3.9 ± 2.5 (difference -2.7 ± 2.5; -42%; P < .0001) without significant difference between Dell grade (P = .055), despite a seemingly smaller number of responders in stage 2 patients. The average analgesic consumption decreased in more than 1 out of 2 patients. In multivariate analysis, no predictor of response was identified. There was no safety issue. All adverse events (11%) were transient increase in pain during or following HA administration and resolved without sequel within 1 to 7 days. CONCLUSIONS: This study suggests that a single course of HANOX-M-XL injection is effective in relieving pain in patients with TMC OA, without safety concern. Patients with advanced stage of OA benefit the treatment as much as those with mild or moderate OA.

Hip Inflammation MRI Scoring System (HIMRISS) to predict response to hyaluronic acid injection in hip osteoarthritis.

OBJECTIVE: To assess predictors of response, according to hip MRI inflammatory scoring system (HIMRISS), in a sample of patients with hip osteoarthritis (OA) treated by hyaluronic acid (HA) injection. METHOD: Sixty patients with hip OA were included. Clinical outcomes were assessed at baseline and three months after HA injection by WOMAC. On hip MRI performed before HA injection, bone marrow lesion (BML) and synovitis were assessed by HIMRISS by four readers. The inter-reader reliability of HIMRISS was for HIMRISS total, acetabular BML, femoral BML and synovitis-effusion respectively 0.86, 0.64, 0.83 and 0.78. Associations between MRI features and clinical data were assessed. Logistic regression (univariate and multivariate) was used to explore associations between MRI features and response to HA injection, according to WOMAC50 response at three months. RESULTS: In total, 45.5% of patients met WOMAC50 response. Five adverse events were reported. At baseline, WOMAC function correlated significantly to HIMRISS synovitis-effusion (r=0.27, P=0.03). In univariate analysis, BML femoral according to binary assessment (P=0.025), HIMRISS BML femoral (P=0.0038), HIMRISS BML acetabular (P=0.042), HIMRISS total (P=0.0092) were associated negatively with WOMAC50 response. In multivariate analysis, adjusted for age and BMI, HIMRISS femoral BML (P=0.02) and HIMRISS total (P=0.016) were negatively associated with response. At a HIMRISS threshold of<15, 82% of patients were responders, with specificity SP=0.97, sensitivity SN=0.39, and positive and negative predictive values of 0.91 and 0.64, respectively. CONCLUSION: HIMRISS is reliable for total scores and sub-domains. It permits identification of responders to HA injection in hip OA patients.

Predictors of response to viscosupplementation in patients with hip osteoarthritis: results of a prospective, observational, multicentre, open-label, pilot study.

BACKGROUND: To identify predictive factors of response to viscosupplementation (VS) in patients with hip osteoarthritis (HOA). METHODS: Prospective, multicentre, open-label trial, achieved in daily practice conditions. Patients with HOA were treated with a single intra-articular injection of a cross-linked hyaluronic acid combined with mannitol (HAnox-M-XL), using imaging guidance. WOMAC pain and function scores and patient global assessment (PGA) were assessed at baseline and day 90. Improvement, satisfaction and efficacy were self-assessed at day 90. Hip radiographs at baseline were scored using Kellgren-Lawrence grade and Osteoarthritis Research Society International (OARSI) score. Associations between clinical and radiological features and response to VS (pain improvement > 50% at day 90) were assessed in univariate analysis, and then using logistic regression, adjusted for confounding factors. RESULTS: The intent-to-treat (ITT) population included 97 patients (57 females, mean age 63). Ninety completed the follow-up and 80 had full clinical and radiological data. Response to VS was achieved in 47.8% of patients. In univariate analysis, the only clinical outcome statistically and negatively related to response was PGA at baseline (p = 0.047). Radiologically, response to VS was negatively correlated with joint space narrowing (JSN) score (JSN < 2 vs. JSN ≥ 2, p = 0.01) and was related to the patterns of femoral head migration (p = 0.008). In multivariate analysis, only JSN grade (p = 0.03) remained significantly related to a poor response. CONCLUSION: This pilot study, which needs further confirmation by larger scale trials, suggests that radiological features might be of importance for the decision of VS in patients with HOA. TRIAL REGISTRATION NUMBER: ID RCB N°2013-A00165-40. Registered 31 January 2013.

Early effect of hyaluronic acid intra-articular injections on serum and urine biomarkers in patients with knee osteoarthritis: An open-label observational prospective study.

The aim of the study was to investigate the effect of hyaluronic acid (HA) intra articular injections (IA) on osteoarthritis (OA) biomarkers in patients with knee OA. Prospective open label study. Fifty-one patients with unilateral symptomatic K-OA received IA injections of 2mL of HA on days (D) 1, 7, 14 and were followed 3 months. At D-15 patients were examined and X-rays performed, to exclude patients with bilateral K-OA, or those with more than three symptomatic OA joints. From 15 days (D-15) before the first injection to D90 concomitant therapies were unchanged. Walking pain (WP) on VAS was obtained at each visit. Urine (U) and serum (S) samples were obtained at D-15, D1, D30, and D90. S-C2C, S-Cartilage oligomeric matrix protein, S-HA, S-CS 846 epitope, S-type II collagen propeptide, and U-type II collagen C telopeptide (U-CTX II/creatinin) were assayed. Predictive factors of response were analyzed using logistic regression. Correlations between variables were obtained using Spearman test. Forty-five patients were analyzed. Between D-15 and D1 there was no difference for any biomarkers At D1, WP (SD) was correlated with U-CTX II/creat (p = 0.006). Between D1 and D90: U-CTX II/creat decreased significantly. After adjustment for confounding variables there was a significant correlation between clinical response and U-CTX II/creat variation. U-CTX II and S-HA at baseline were independently predictive of clinical response. This study showed that 90 days after HA IA injections, U-CTX II levels significantly decrease compared to baseline, suggesting a slowdown of type II collagen degradation.

[Long-life learning for medical specialists doctors in Europe: CME, DPC and qualification]. / Apprentissage tout au long de la vie pour les médecins spécialistes en Europe : formation médicale continue, développement professionnel continu et qualifications.

The Union européenne des médecins spécialistes (UEMS) has a mandate to lead the quality of care in Europe and harmonise the qualifications of specialists doctors. In 2000, UEMS has set the European Accreditation Council for Continuing Medical Education (EACCME), with the objective to accredit educational events and facilitate the reciprocity of CME credits obtained by attending international medical conferences. In 2010, UEMS has set the European Accreditation Council for Medical Specialist Qualification (EACMSQ). This 2-year pilot project concerns three specialties with the goal to harmonise the competencies' assessment. In 2010, 35 countries are UEMS members, corresponding to 1,5 millions specialists doctors. Each of the 38 medical specialties has a 'section' and a four-members' board. Since 2000, the Europe developed the CPD concepts, and definitions were customised per country and health systems. The Rome group defined the CPD: "Continuing professional development is the educative means of updating, developing and enhancing how doctors apply the knowledge, skills and attitudes required in their working lives. This includes CME, professional and managerial (non-clinical) competencies, and all elements of Good Medical Practice". The learning concepts must be better developed in the health care systems as it has been done in other sectors of activity. Learning is the concept considering that it's no more possible to characterise the learner as a sponge absorbing information. The virtuous cycle of CME is well-known: assess his professional needs; set the needs and objectives; implement an educational plan with the right methods; conduct the actions and get the data; assess the events according to levels (participation, satisfaction, learning, performance, patient's health, population's health). Financing of events usually is shared between payers: state, insurers, industries, doctors but in fine, the public is the major payer. Education must be independent from all influences and recommendations should be set. Countries have mandatory or voluntary CME/CPD systems but it's not a criterium of a better performance. National authorities accredit organisms or events, and that does not make any difference.

Retos de la formación médica continuada / Challenges in the CPD and the regulation of the profession

No disponible