INTRODUCTION: Knee osteoarthritis (OA) is the most common articular disease. Different methods are used to alleviate the symptoms of patients with knee OA, including analgesics, physical therapy, exercise prescription, and intra-articular injections (glucocorticoids, hyaluronic acid [HA], etc). New studies have focused on modern therapeutic methods that stimulate cartilage healing process and improve the damage, including the use of platelet-rich plasma (PRP) as a complex of growth factors. Due to the high incidence of OA and its consequences, we decided to study the long-term effect of intraarticular injection of PRP and HA on clinical outcome and quality of life of patients with knee OA. METHOD: This non-placebo-controlled randomized clinical trial involved 160 patients affected by knee OA, grade 1-4 of Kellgren--Lawrence scale. In the PRP group (n = 87), two intra-articular injections at 4-week interval were applied, and in the HA group (n = 73), three doses of intra-articular injection at 1-week interval were applied. All patients were prospectively evaluated before and at 12 months after the treatment by Western Ontario and McMaster Universities Arthritis Index (WOMAC) and SF-36 questionnaires. The results were analyzed using SPSS 16.1 software (RCT code: IRCT2014012113442N5). RESULTS: At the 12-month follow-up, WOMAC pain score and bodily pain significantly improved in both groups; however, better results were determined in the PRP group compared to the HA group (P < 0.001). Other WOMAC and SF-36 parameters improved only in the PRP group. More improvement (but not statistically significant) was achieved in patients with grade 2 OA in both the groups. CONCLUSION: This study suggests that PRP injection is more efficacious than HA injection in reducing symptoms and improving quality of life and is a therapeutic option in select patients with knee OA who have not responded to conventional treatment.
<b>OBJECTIVES: </b>To compare the effects of an intermediate molecular weight (MW) intra-articular hyaluronic acid (HA) with a low MW product on knee osteoarthritis (OA) symptoms.<b>METHODS: </b>Patients with symptomatic knee OA were enrolled inarandomised, controlled, double-blind, parallel-group, non-inferiority trial with the possibility to shift to superiority. Patients were randomised to GO-ON(MW 800-1500 kD, 25 mg/2.5 ml) or Hyalgan(MW 500-730 kD, 20 mg/2 ml) injected at 3-weekly intervals. The primary outcome was 6-month change in the WOMAC pain subscale (0-100 mm). Sample size was calculated on a non-inferiority margin of 9 mm, lower than the minimum perceptible clinical improvement. Secondary endpoints included OARSI-OMERACT responder rates<b>RESULTS: </b>The intention-to-treat (ITT) and per-protocol (PP) populations consisted of 217 and 209 patients and 171 and 172 patients in the GO-ON and Hyalgan groups, respectively. ITT WOMAC pain of 47.5±1.0(SE) and 48.8±1.0 mm decreased by 22.9±1.4 mm with GO-ON and 18.4±1.5 mm with Hyalgan after 6 months. The primary analysis was conducted in the PP population followed by the ITT population.Mean (95% CI) differences in WOMAC pain change were 5.2 (0.9 to 9.6)mm and 4.5 (0.5 to 8.5)mm, respectively,favouring GO-ON, satisfying the claim for non-inferiority (lower limit>-9 mm) and for statistical superiority (95% CI all>0, p=0.021). Ahigher proportion of OARSI/OMERACT responders was observed with GO-ONthan with Hyalgan (73.3% vs58.4%, p=0.001). Both preparations were well tolerated.<b>CONCLUSIONS: </b>Treatment with 3-weekly injections of intermediate MW HA may be superior to low MW HA on knee OA symptoms over 6 months, with similar safety.
OBJECTIVES: To compare the efficacy and safety of a 'medium' molecular weight (MW) hyaluronan product (F60027, Structovial) with a 'high' MW (Hylan G-F20, Synvisc).
METHODS: Prospective, randomised, multicentre, double-blind, active controlled, parallel-group study with a non-inferiority design. Patients with symptomatic KOA, global pain ≥ 40 mm (VAS, 0-100), Lequesne index (LFI, 0-24) score >7 and radiological Kellgren-Lawrence grade 2/3 were centrally randomised to receive F60027 or Hylan G-F20, administered via three weekly injections, with regular follow-up evaluations up to week 24 (W24). The primary outcome was LFI score change over 24 weeks. Secondary outcomes comprised pain VAS, quality of life, patient's and physician's global assessments, rescue medication consumption and OMERACT-OARSI responders rate.
RESULTS: 276 patients were analysed in the full analysis dataset (FAS), 236 in the Per Protocol dataset (PP). In the main efficacy analysis (PP), the difference of the LFI score change over 24 weeks between F60027 (-4.67 (0.27)) and Hylan G-F20 (-4.54 (0.28)) was 0.132 [95%CI: -0.598, 0.861] which met the predefined non-inferiority margin. Analyses of secondary efficacy criteria showed clinically relevant improvements of all outcomes at W24 for each treatment on both PP/FAS populations. Changes of LFI score between baseline and W24 were -5.73 in the F60027 and -5.57 in the Hylan G-F20 group (PP dataset). Few local reactions were reported: 3.6% of patients in each group.
CONCLUSIONS: F60027 and Hylan G-F20 were equally effective in reducing functional impairment and relieving pain in KOA patients, and well-tolerated.
OBJETIVO: Evaluar la eficacia a largo plazo y la seguridad de cinco inyecciones intraarticulares con ácido hialurónico en la artrosis de rodilla.
MÉTODOS: Un ensayo multicéntrico, aleatorizado, controlado con placebo, doble ciego de 337 pacientes que cumplieron con el American College of Rheumatology (ACR) para la osteoartritis de rodilla (clínicos y de laboratorio) y con una puntuación del índice de Lequesne algofunctional (LFI) de 10 o mayor. Los pacientes recibieron un producto de ácido hialurónico (hialuronato de sodio; Hyalgan) (n = 167) o solución salina (n = 170) de forma intraarticular semanal durante 5 semanas y se realizó un seguimiento de 1 año. El tiempo de recurrencia fue el parámetro principal de eficacia. LFI, dolor al caminar 50 m según la escala visual analógica (EVA dolor 50 m), el consumo de paracetamol, la evaluación global de los pacientes, el perfil de salud de Nottingham, derrame articular y el número de pacientes que respondieron fueron parámetros de eficacia secundarios. Los parámetros de eficacia fueron analizados por intención de tratar (ITT) y por protocolo (PP). Todos los eventos adversos (AE) se registraron como parámetros de seguridad.
RESULTADOS: El tiempo hasta la recurrencia no mostró ningún efecto significativo del tratamiento (análisis ITT, p = 0,26). Cambio desde el inicio en LFI y el dolor VAS 50 m para la población ITT no mostró ningún efecto del tratamiento. El consumo de paracetamol, la evaluación global de los pacientes, las tasas de respuesta y AE no mostró diferencias significativas entre los grupos de tratamiento, analizados tanto por ITT y PP. El cumplimiento del tratamiento fue del 95% en el grupo de ácido hialurónico y 99% en el grupo placebo. No hay problemas de seguridad fueron registrados.
CONCLUSIÓN: En los pacientes que cumplen los criterios de la ACR para la osteoartritis de la rodilla con actividad moderada a severa enfermedad (LFI> o = 10), cinco inyecciones intraarticulares de ácido hialurónico no mejoró el dolor, la función, el consumo de paracetamol u otros parámetros de eficacia 3, 6 , 9 y 12 meses después del tratamiento.
OBJETIVOS: El tratamiento conservador debe ser juzgado antes del tratamiento quirúrgico de la artrosis de rodilla. Este estudio fue diseñado para evaluar los efectos a corto plazo de la terapia de barro-pack en el alivio del dolor y la mejoría funcional en la osteoartritis de rodilla en comparación con las inyecciones de ácido hialurónico intraarticular.
Métodos: El estudio incluyó a 23 pacientes que fueron diagnosticados con artrosis de rodilla según los criterios del ACR (American College of Rheumatology), y tenía quejas que duran más de tres meses. Todos los pacientes tenían etapa 2 o 3 osteoartritis radiográficamente de acuerdo con los criterios de Kellgren-Lawrence. Doce pacientes (3 varones, 9 mujeres, edad media 54 +/- 6 años, rango 46 a 67 años) recibieron terapia de barro de forma bilateral. paquetes de barro se calentaron a 45 grados C y se aplican en ambas rodillas durante 30 minutos al día durante un total de 12 días de la semana. Once pacientes (2 varones, 9 mujeres, edad media 53 +/- 9 años, rango 40 a 66 años) recibieron un total de tres inyecciones de ácido hialurónico intraarticulares bilaterales, cada intercalados con intervalos de una semana. Los pacientes fueron evaluados antes y después del tratamiento en términos de dolor y funcionalidad utilizando la subescala de dolor del WOMAC (Western Ontario y McMaster Universidades) índice de osteoartritis, el Hospital for Special Surgery (HSS) Resultado, y el sistema de clasificación clínica de la Sociedad de la rodilla (rodilla y la función puntuaciones). Los pacientes fueron seguidos durante una media de 5,9 +/- 6,3 meses (rango de 4 a 8 meses) después de la terapia de barro-pack, y 5,8 +/- 0,8 meses (rango de 5 a 7 meses) después de las inyecciones de ácido hialurónico intraarticular .
Resultados: No se encontraron diferencias significativas entre los dos grupos con respecto a la pre-y post-tratamiento de WOMAC, HSS, y las puntuaciones de rodilla y de función (p> 0,05). Las puntuaciones de todos los instrumentos mostraron mejoras significativas después del tratamiento en ambos grupos (p <0,001). cambios después del tratamiento en relación con las puntuaciones iniciales no difirieron significativamente entre los dos grupos (p> 0,05).
CONCLUSIÓN: El tratamiento de la artrosis de rodilla con inyecciones de ácido hialurónico intraarticular o fangoterapia-pack arrojó resultados similares en el corto plazo en cuanto a la mejoría funcional y el alivio del dolor. fangoterapia-pack es una modalidad alternativa no invasiva, sin complicaciones, y rentable para el tratamiento conservador de la osteoartritis de rodilla.
BACKGROUND/PURPOSE: Intra-articular injection of hyaluronan (hyaluronic acid; HA) products is available to treat early osteoarthritis (OA) of the knee in Taiwan. We tested whether HA products with different molecular weights have significantly different effects on clinical efficacy and cost-effectiveness.
METHODS: Thirty-seven patients with mild to moderate OA of both knees underwent five weekly intra-articular injections of sodium hyaluronate (Artz) in one knee and three weekly intra-articular injections of chemically cross-linked Hylan G-F 20 (Synvisc) in the other. Visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne's index, and Hospital for Special Surgery (HSS) knee scores were compared initially and at the last injection, and at 8, 12, 16, 20, and 26 weeks after the first injection.
RESULTS: VAS, WOMAC, WOMAC-A1 (pain when walking on a flat surface) scores before week 16, HSS scores before week 12, and Lequesne's index scores except at week 26 all showed that HA significantly improved the scores time-dependently. In VAS scores, Synvisc showed better improvement before week 20, while this effect appeared at week 12 for the WOMAC-A1 scores. The incremental cost-effectiveness ratio of the Taiwan National Health Insurance Program, of the patient, and both of these was lower for Synvisc, which also reduced the number of additional hospital visits for injections by two.
CONCLUSION: Synvisc possesses better symptom-modifying ability and cost-utility in treating early OA of the knee in Taiwan.
OBJETIVO: Describir el juicio FLEXX, el primer estudio bien controlado para evaluar la seguridad y eficacia de Euflexxa (1% de hialuronato de sodio; IA-BioHA) terapia para la osteoartritis de rodilla (OA) a las 26 semanas.
MÉTODOS: Este fue un estudio doble ciego, multicéntrico, aleatorizado, controlado con solución salina. Los sujetos con OA de rodilla crónica fueron asignados al azar a 3 intraarticular (IA) inyecciones semanales de solución salina tamponada (IA-SA) o IA-BioHA (20 mg / 2 ml). La variable principal de eficacia fue objeto de la diferencia registrada en mínimos cuadrados medios entre IA-BioHA e IA-SA en el cambio de los sujetos desde el inicio hasta la semana 26 después de una prueba de caminata de 50 pies, medida a través de 100 mm escala analógica visual (VAS). Las medidas de resultado secundarias incluyeron osteoartritis Sociedad Internacional de Investigación de respuesta índice, la Universidad de Western Ontario McMaster Artrosis Índice VA 3.1 subescalas, la evaluación global del paciente, la medicación de rescate, y la calidad relacionada con la salud de la vida (CVRS) por el SF-36. La seguridad se evaluó mediante la supervisión y presentación de informes signos vitales, examen físico de la rodilla de destino después de la inyección, los eventos adversos, y los medicamentos concomitantes.
RESULTADOS: Quinientos ochenta y ocho sujetos fueron asignados al azar a cualquiera de IA-BioHA (n = 293) o IA-SA (n = 295), con una tasa de finalización de 26 semanas 88%. No se observaron diferencias estadísticas entre los grupos de tratamiento al inicio del estudio. En el grupo IA-BioHA, medias de EVA disminuyeron en 25,7 mm, en comparación con 18,5 mm en el grupo IA-SA. Esto corresponde a una reducción media del 53% del valor inicial para IA-BioHA y una reducción del 38% para IA-SA. La diferencia de mínimos cuadrados medios fue -6.6 mm (P = 0,002). Medidas de resultado secundarias fueron consistentes con una mejora significativa en la osteoartritis de Investigación de la Sociedad Internacional de respuesta índice, la CVRS y función. Tanto IA-SA y IA-BioHA inyecciones fueron bien tolerados, con una baja incidencia de eventos adversos que se distribuyeron por igual entre los grupos. Reacciones sitio de la inyección fueron reportados por 1 (<1%) sujetos en el grupo IA-SA y 2 (1%) en el grupo IA-BioHA.
CONCLUSIONES: La terapia IA-BioHA resultaron en un alivio significativo del dolor de rodilla OA a las 26 semanas en comparación con IA-SA. Los sujetos tratados con IA-BioHA también experimentaron mejoras significativas en la función de las articulaciones, satisfacción con el tratamiento, y la CVRS.
BACKGROUND: Intra-articular injection of hyaluronic acid has become an intervention step between conservative and operative treatment of knee osteoarthritis. This is recommended by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR). However, the expected outcomes and the selection criteria are undetermined and controversial. A few articles have mentioned the long-term result of Sodium Hyaluronate in failed conservative treatment.
OBJECTIVE: Determine the clinical outcomes of treatment with three intra-articular Sodium Hyaluronate injections (500-730 kilodalton (KDA), Hyalgan) in knee-osteoarthritis patients who failed conservative treat-ment.
MATERIAL AND METHOD: This was an uncontrolled, retrospective-cohort study with at least a 24-month followup period. The outcomes of the treatment were evaluated by questionnaires and telephone calls. The primary efficacy parameter was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score and the secondary efficacy parameter was delay or cancellation of any surgical treatments during the followup period. Patients who had undergone surgical treatments were placed in the non-response group. The response group has repeated treatment every year.
RESULTS: One hundred and eighty-three patients (208 knees) treated with intra-articular Sodium Hyaluronate were classified into three groups according to radiographic assessment. In group 1, narrowing joint space (Ahlback grade 1-2), WOMAC score improved from 70.46 to 26.55 (p < 0.0001), 41 in 46 patients (44/49 knees) did not require any surgical treatments. In group 2, bony attrition (Ahlback grade 3-4), WOMAC score improved from 70.19 to 40.38 (p < 0.0001), 47 in 70 patients (51/78 knees) did not require surgical treatment. In group 3, lateral subluxation (Ahlback grade 5) WOMAC score improved from 64.71 to 32.67 (p < 0.0001), 58 in 67 patients (69/81knees) did not require surgical treatment. The result from WOMAC subscale analysis revealed an improvement in pain, stiffness, and function in all groups (p < 0.0001), but did not improve in ambulatory status.
CONCLUSION: Intra-articular Sodium Hyaluronate injection, used in knee-osteoarthritis patients who failed conservative treatment, was effective in visible cartilage patients (Ahlback grade 1, 2) without mechanical problems involved. In severe osteoarthritis patients (Ahlback grade 3, 4, 5), this treatment was of less benefit if those patients were young, active, and expected independent ambulation. Surgical treatment may be a procedure of choice to meet patient expectation in improving function and ambulatory status. On the other hand, if patients were old and inactive with household ambulation, using intra-articular Sodium Hyaluronate was beneficial in improving pain, stiffness, and function but not ambulation level with 86.56% of excellent or good in overall satisfaction level. Thus, the radiographic evaluation, age, ambulatory status, and patient expectation may be the key factors to determine successful outcomes.
OBJECTIVE: To assess the efficacy and safety of intra-articular injections of sodium hyaluronate combined with a home exercise program (HEP) in the management of pain associated with osteoarthritis (OA) of the knee.
DESIGN: Single-blinded, parallel-design, 1-year clinical study with sequential enrollment.
SETTING: University-based outpatient physiatric practice.
PARTICIPANTS: Sixty patients (18 men, 42 women; age, > or =50 y) with moderate-to-severe pain associated with OA of the knee.
INTERVENTIONS: (1) Five weekly intra-articular hyaluronate injections (5-HYL); (2) 3 weekly intra-articular hyaluronate injections (3-HYL); or (3) a combination of an HEP with 3 weekly intra-articular hyaluronate injections (3-HYL+HEP).
MAIN OUTCOME MEASURES: The primary outcome measure was a 100-mm visual analog scale for pain after a 50-foot walk (15.24 m). Secondary measures included the Western Ontario and McMaster Universities Osteoarthritis Index subscales.
RESULTS: The 3-HYL+HEP group had significantly faster onset of pain relief compared with the 3-HYL (P<.01) and 5-HYL groups (P=.01). All groups showed a mean symptomatic improvement from baseline (reduction in baseline pain at 3 mo was 59%, 49%, and 48% for the 3-HYL+HEP, 3-HYL, and 5-HYL groups, respectively) that was clinically and statistically significant. There were no between-group differences in the incidence or nature of adverse events.
CONCLUSIONS: The combined use of hyaluronate injections with HEP should be considered for management of moderate-to-severe pain in patients with knee OA.
Knee osteoarthritis (OA) is the most common articular disease. Different methods are used to alleviate the symptoms of patients with knee OA, including analgesics, physical therapy, exercise prescription, and intra-articular injections (glucocorticoids, hyaluronic acid [HA], etc). New studies have focused on modern therapeutic methods that stimulate cartilage healing process and improve the damage, including the use of platelet-rich plasma (PRP) as a complex of growth factors. Due to the high incidence of OA and its consequences, we decided to study the long-term effect of intraarticular injection of PRP and HA on clinical outcome and quality of life of patients with knee OA.
METHOD:
This non-placebo-controlled randomized clinical trial involved 160 patients affected by knee OA, grade 1-4 of Kellgren--Lawrence scale. In the PRP group (n = 87), two intra-articular injections at 4-week interval were applied, and in the HA group (n = 73), three doses of intra-articular injection at 1-week interval were applied. All patients were prospectively evaluated before and at 12 months after the treatment by Western Ontario and McMaster Universities Arthritis Index (WOMAC) and SF-36 questionnaires. The results were analyzed using SPSS 16.1 software (RCT code: IRCT2014012113442N5).
RESULTS:
At the 12-month follow-up, WOMAC pain score and bodily pain significantly improved in both groups; however, better results were determined in the PRP group compared to the HA group (P < 0.001). Other WOMAC and SF-36 parameters improved only in the PRP group. More improvement (but not statistically significant) was achieved in patients with grade 2 OA in both the groups.
CONCLUSION:
This study suggests that PRP injection is more efficacious than HA injection in reducing symptoms and improving quality of life and is a therapeutic option in select patients with knee OA who have not responded to conventional treatment.
Diseño del estudio»Ensayo controlado aleatorizado (ECA)
