BackgroundViscosupplementation of the synovial liquid, by intra-articular injection of hyaluronic acid, is a widely used symptomatic treatment in knee osteoarthritis. Besides products designed for multi-injections (typically 3–5 injections at 1-week intervals), special interest is being given to single-injection products that offer specific advantages such as the reduction of the number of visits to the doctor and the number of invasive interventions with their associated risks. However, a question remains about the efficacy of these monoinjections, compared with the multi-injections regimens.MethodsA postmarket, prospective, multicenter, open study (ART-ONE 75), was performed with the single-injection product Arthrum 2.5% (3 mL, 75 mg hyaluronic acid) (LCA Pharmaceutical, Chartres, France), on 214 patients with knee osteoarthritis. Patients were followed at 30, 60, 120, and 180 days. The average patient profile at inclusion was age 62.9 years, 56% were women, Kellgren-Lawrence (KL) grade I through III (46% Kellgren-Lawrence status III), body mass index 27.2, and 4 years osteoarthritis anteriority. A post hoc comparison was performed using a single intra-articular injection placebo (326 patients, pooled from 3 randomized controlled trials) providing a similar patient profile.ResultsThe main criterion was the variation from baseline of the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, pain subscale (A) score (range 0-100), at 60 days, which was reduced by 28.9 (17.4) for the intent-to-treat population (199 patients), 28.0 (17.8) for the per protocol at inclusion population (175 patients), and by 27.7 (16.8) for the per protocol completed population (143 patients). The secondary and accessory criteria included WOMAC A score at the other times, WOMAC B (stiffness) score, WOMAC C (function) score, quality of life, and handicap at each follow-up time. All indexes were significantly improved and continued to improve at the end of the study. The therapeutic assessment at 180 days showed more than 75% of patients were satisfied with pain reduction, mobility improvement, and reduction in taking analgesics and nonsteroidal anti-inflammatory drugs. The percentage of patients defined as Outcome Measures in Rheumatology Clinical Trials–Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI) responders was >86%, from 60 days onward. The overall tolerance was good, without any serious adverse event. The result of the post hoc comparison for the WOMAC A score showed an effect size from 0.33 (95% CI 0.15–0.51) at 60 days to 0.65 (95% CI 0.45–0.85) at 180 days (P < 0.001), versus injected placebo (saline solution), which is clinically relevant in favor of Arthrum 2.5%.ConclusionsThe present study suggests the clinical efficacy of a single intra-articular injection of 3 mL intra-articular hyaluronic acid solution containing 75 mg high molecular weight (>2 MDa) native hyaluronic acid.
This study compares knee extension and flexion torques and electromyographic (EMG) activity of normal and anterior cruciate ligament (ACL)-reconstructed knees during maximal unilateral isometric and isokinetic tests performed 4-5 months after ACL reconstruction. The subjects consisted of 3 age-and activity-matched groups of 6 subjects: a healthy control group (Ctrl) and 2 groups of patients, with Kenneth-Jones technique using autologous patellar-ligament graft (KJ group) and autologous graft from the semitendinosus tendon (ST group). When compared to the Ctrl group values, each patient group had significant bilateral extension torque deficits in isometric and at slow velocity concentric conditions. In the Op leg, this deficit was associated with lower quadriceps EMG activation. In all tests, bilateral hamstring co-activation level was lower in the patient groups. Flexion torque deficits were observed in the Op leg of both patient groups and in the Nop leg of the KJ group, with minor differences in either hamstring EMG activation or quadriceps co-activation. The inter-leg difference in extension and flexion torques were significant for both patient groups, but only in the isometric strength test, and with no difference in activation. These data demonstrate bilateral knee extension and flexion torque deficits a few months after ACL reconstruction. The observed deficit in quadriceps activation emphasizes the interest to perform combined EMG and strength testings quite early during the rehabilitation period.
Resumen Introducción La viscosuplementación del líquido sinovial mediante la inyección intraarticular (IA) de ácido hialurónico (AH) es un tratamiento sintomático ampliamente utilizado en la artrosis de rodilla (AR). Además de los productos diseñados para realizar inyecciones múltiples (normalmente de 3 a 5 inyecciones, en intervalos de 1 semana), se presta especial atención a los productos de una única inyección, ya que ofrecen ventajas específicas, como son un menor número de visitas al médico y de intervenciones invasivas con sus riesgos asociados. Sin embargo, aún existen dudas sobre la eficacia de estas inyecciones únicas, en comparación con los regímenes de inyecciones múltiples. Métodos Se realizó un estudio multicéntrico, abierto, prospectivo, post-mercado (ART-ONE 75) con el producto de inyección única ARTHRUM 2,5% (3 ml, 75 mg AH), en 214 pacientes que sufrían de AR. Los pacientes fueron seguidos en D30, D60, D120 y D180 (días). El perfil promedio de los pacientes en el momento de la inclusión fue de 62,9 años, 56% mujeres, grados I-III de Kellgren-Lawrence (46% KL III), IMC de 27,2 kg/m 2 y 4 años desde el diagnóstico de AR. Se realizó una comparación post-hoc con una inyección IA única de placebo (326 pacientes, agrupados de 3 estudios ECA), que proporcionaron un perfil de paciente similar. Resultados el criterio principal fue la variación desde el inicio de la puntuación de la escala WOMAC A (dolor, escala 0-100) en D60, que se redujo en 28,9 (17,4) para la población por intención de tratar (ITT, por sus siglas en inglés) (199 pacientes), 28,0 (17,8) para la población por protocolo (PP) en la inclusión (175 pacientes), y en 27,7 (16,8) para la población PP al finalizar (143 pacientes). Los criterios secundarios y accesorios incluyeron WOMAC A en otras ocasiones, WOMAC B (rigidez), WOMAC C (función), calidad de vida y discapacidad en cada momento de seguimiento. Todos los índices mejoraron significativamente y continuaron mejorando al final del estudio. La evaluación terapéutica en D180 mostró que más del 75% de los pacientes se encontraban satisfechos con la reducción del dolor, la mejora de la movilidad, y la reducción de analgésicos y AINE. El porcentaje de pacientes definidos como respondedores de OMERACT-OARSI fue superior al 86%, a partir de D60 y en adelante. La tolerancia general fue buena, sin que ocurriera ningún evento adverso grave. El resultado de la comparación post-hoc para la escala WOMAC A mostró un tamaño del efecto [IC 95%] desde TE = 0,33 [0,15; 0,51] en D60 a TE = 0,65 [0,45; 0,85] en D180 (p <0,001), frente a la inyección de placebo (solución salina), lo cual es un resultado clínicamente relevante a favor de ARTHRUM 2,5%. Conclusión El presente estudio confirma la eficacia clínica de una única inyección IA de 3 ml de solución de AH conteniendo 75 mg de AH nativo de alto PM (> 2 MDa).
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