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Cesáreo Ángel Trueba Davalillo,1,2 Cesáreo Trueba Vasavilbaso,2 José Mario Navarrete Álvarez,2 Pilar Coronel Granado,3 Ozcar Alejandro García Jiménez,2 Mercedes Gimeno del Sol,3 Félix Gil Orbezo2 1School of Medicine (UNAM), México DF, Mexico; 2Orthopedic Service, Hospital Español de México, México DF, Mexico; 3Scientific Department, TEDEC-MEIJI FARMA,SA, Alcalá de Henares, Spain Background: Osteoarthritis (OA) is the most common joint disease and leading cause of disability. Intra-articular (IA) administration of hyaluronic acid (HA) or corticosteroids (CS) have been previously studied, though using insufficient number of patients or short follow-up periods.Objective: We evaluate HA and CS in patients with knee OA in terms of clinical efficacy over 12 months.Methods: We used a prospective, randomized study with parallel groups. Randomized patients received IA injections of HA or betamethasone (BM). The primary outcomes were improvement in pain using Visual Analog Scale and function in the Western Ontario and McMaster University Osteoarthritis Index (Likert scale). Follow-up visits were scheduled at 3 months, 6 months, 9 months, and 12 months.Results: A total of 200 patients were included. Pain was significantly reduced in both groups at the first follow-ups. At 12 months, the mean pain reduction in the HA group was 33.6% (95% CI: 31.1–36.1) compared to 8.2% (95% CI: 5.2–11.1) in BM (P

Alejandro Alcina Navarro,1 Sara Gómez Valero,1 Mercedes Gimeno del Sol,2 María Pilar Coronel Granado2 1Rehabilitation Department, Hospital Universitario del Henares, Coslada, Madrid, Spain; 2Scientific Department, Meiji Pharma Spain, Alcalá de Henares, Madrid, SpainCorrespondence: María Pilar Coronel Granado, Scientific Department, Meiji Pharma Spain, Avda de Madrid, 94, Alcalá de Henares, Madrid, 28802, Spain, Tel +34 91 8870980, Email p.coronel@meiji.esPurpose: The entry into force of the new Medical Device Regulation (EU) 2017/745 highlights the need for post-market clinical follow-up to ensure the safety and efficacy throughout the life cycle of medical devices. This study evaluates the efficacy and safety of a single intra-articular hyaluronic acid injection in knee osteoarthritis in real-world conditions, over a six-month period, aligning with the summary of safety and clinical performance (SSCP) required by the new regulation.Patients and Methods: Patients over 18 years of age with knee osteoarthritis, treated with a single injection of HA (Adant® One, Meiji Pharma Spain, Spain) at a 3rd level hospital. Patients were treated and followed between January 1, 2020 and June 30, 2022. Demographic, clinical, and treatment-related data were collected, and efficacy regarding pain relief and/or function improvement was assessed using a Likert-type scale. Data were pseudo-anonymized and the comparison was performed using Fisher’ or Mann Whitney’ test. The study was approved by the Ethics Review Board of the Hospital Puerta de Hierro (Madrid, Spain).Results: We followed 20 patients with knee osteoarthritis, with a mean age of 61 years, 80% women, and with a high burden of comorbidities (90%). A total of 60% of patients presented Kellgren-Lawrence grade III–IV. Four patients (20%) returned before 6 months due to lack of efficacy. Of the other patients, 65% showed a clinical response that lasted more than 12 months in 38.5% of cases. Time until medical appointment and taking concomitant medication for knee osteoarthritis were associated with better clinical response (p < 0.05).Conclusion: The administration of a Adant® One single intra-articular hyaluronic acid injection in knee osteoarthritis is effective, safe, and maintains the improvement over a six-month period. Our findings also emphasize the need of using standardized tools for accurate efficacy assessment and optimal patient care.Keywords: rehabilitation, real clinical practice, rheumatology, traumatology

Cesáreo Trueba Vasavilbaso,1 Carlos David Rosas Bello,1 Erla Medina López,2 Maria Pilar Coronel Granado,3 José Mario Navarrete Álvarez,1 Cesáreo Angel Trueba Davalillo,4 Félix Isaac Gil Orbezo5 1Orthopedics Department, Hospital Español de México, Mexico DF, 2Orthopedics Department, Hospital Médica Sur, Mexico City, Mexico; 3International Development, Tedec Meiji Farma SA, Madrid, Spain; 4Orthopedics University Master (National University of Mexico, UNAM), 5Orthopedics Department, Hospital Español de México, Mexico City, Mexico Purpose: To assess the effectiveness of viscosupplementation or platelet-rich plasma (PRP), compared to standard care, for pain relief after knee arthroscopic debridement in patients with meniscal pathology and osteoarthritis (OA), under normal clinical practice conditions.Patients and methods: We conducted a prospective, randomized, evaluator-blind, pilot study. After arthroscopy, patients were randomized to receive 1) five injections of HA1 (Suprahyal®/Adant®); 2) four injections of HA2 (Orthovisc®); 3) three injections of HA3 (Synvisc®); 4) a single injection of PRP (GPS™ II); or 5) standard care (control). Patients were followed up for 18 months. Clinical outcomes were evaluated using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 3, 6, 12, and 18 months. Minimally Clinical Important Improvement (MCII), as relative improvement ≥20 for pain and function, was also calculated.Results: Fifty patients were included. At early follow-up (3 months), total WOMAC scores improved in all groups compared to baseline with reductions of 44.79% (HA1), 24.02% (HA2), 40.38% (HA3), 39.77% (PRP), and 27.64% (control) (p=0.002 HA1 compared to HA2). At 18 months, the higher improvement in total WOMAC was in HA1 with a 65.20% reduction, followed by PRP (55.01%), HA3 (49.57%), and HA2 (29.82%), whereas the control group had a 14.55% increase over baseline (p=0.001 control compared to HA1 and HA3). The percentage of patients achieving the MCII for both pain and function at 18 months was 100% (HA1), 80% (HA3), 60% (HA2), and 60% (PRP), whereas, in the control group, all patients returned to pre-arthroscopy levels. There were no adverse events attributable to surgery or to intraarticular administration.Conclusion: Viscosupplementation following arthroscopy is more effective than PRP in adequately selected patients with meniscal lesions occurring concomitantly with OA. Further controlled studies with a larger sample size and/or alternative regimens would be of interest for the scientific community. Keywords: arthroscopy, osteoarthritis, viscosupplementation, PRP

Purpose: This study aims to evaluate the real-world efficacy and safety of intra-articular (IA) hyaluronic acid (HA) injections in patients with hip osteoarthritis (OA). Given the increasing burden of hip osteoarthritis and limited evidence supporting viscosupplementation in this context, this research aims to provide valuable insights under real clinical practice conditions., Patients and Methods: An observational, cross-sectional and retrospective study was conducted in a cohort of patients with hip OA treated with a single injection of HA (Adant One, Meiji Pharma Spain, Spain) from January 2021 to December 2022. Data on patient demographics, clinical characteristics, and treatment outcomes were collected. Efficacy regarding pain relief and/or function improvement was assessed at 6 months using the Visual Analogue Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Data were pseudonymized. The study was approved by the Research Ethics Committee of the Autonomous Community of Aragon (CEICA)., Results: The study included 40 patients with a mean age of 62.8 years, with 72.5% being female. Significant improvement was observed six-months post-treatment: 25% and 18.5% reduction in pain (VAS and WOMAC, respectively), 11.6% improvement in function (WOMAC), 7.4% improvement in stiffness (WOMAC), and 13.6% improvement in total WOMAC. No adverse events were reported., Conclusion: A single injection of IA HA significantly improved pain and function in patients with hip OA. These findings support the use of viscosupplementation for hip OA management and underscore the need for further studies to confirm these results and assess the long-term benefits of IA HA in hip OA., Competing Interests: P. Coronel and E. Gómez-Rubio are employees of Meiji Pharma Spain. The other authors declare no conflicts of interest., (© 2024 Santamaría Torroba et al.)

A comparative study of Cefminox, a new cefamicin, and Cefotaxime was conducted to evaluate the efficacy and safety of the former in the treatment of complicated urinary infection, and to correlate in both cases the bacteriological response with isolates MICs. To this end a phase III, randomized, blind and controlled clinical trial was conducted in 22 patients who met the study's preestablished criteria, 19 of which were evaluable. Both treatments achieved 100% clinical efficacy, while microbiological eradication was accomplished in 90.9% patients treated with Cefminox and 75% patients who received the comparator. Cefminox shows greater in vivo activity than that expected for the MICs, excellent efficacy and safety.