We retrospectively examined prospective data on the incidence and time to total knee replacement (TKR) in (1) patients with grade IV osteoarthritis (OA) treated with hylan G-F 20 from 1997 to 2010 (full cohort; 1,863 knees) and (2) a patient subset treated from 1997 to 2003 (original cohort; 1,187 knees) to determine any continued hylan G-F 20 influence on TKR delay. In both the cohorts, 25 to 28% knees underwent a TKR, with an average of 2.8 to 3.1 years occurring between hylan G-F 20 and surgery. Age was a significant predictor of time to TKR. Knee synovitis increased slightly with repeat courses; most cases considered mild or moderate. Survival analysis showed that TKR was delayed for > 7 years in 75% of 1,863 grade IV OA knees (1,342 patients) treated with hylan G-F 20 in an orthopedic practice. Consistent with our previous report (Waddell and Bricker, 2007), we show hylan G-F 20 continues to delay the need for TKR.
OBJECTIVE: In the year 2006 the Hospital Complex of Jaén began a new model of attention for consultation of knee osteoarthritis (CMAR), to offer quality treatment to the patient based on clinical practice guidelines. The objective of this study was to analyse the efficiency of the unit, in terms of delaying the time until a knee prostheses is needed.
PATIENTS AND METHODS: An analysis of a retrospective cohort of patients seen at the CMAR was made, with a minimum available data set, and a Kaplan Meier analysis carried out in order to evaluate the time until the referral of the patient to surgery, as well as a Cox regression analysis in order to study the factors related with the time until the referral.
RESULTS: 224 patients were included, with mean age of 65.7 years (95% CI 64 to 67), 67.9% women. 48.2% had a stage III affection (Kellgren-Lawrence), 27.5% stage 2, 15.3% stage 4, and 9% stage 1. 90.2% (202) received treatment with viscosupplementation (Hialuronic acid NASHA). Single joint affection (P<.0001; OR 0,267, 95% CI 0.130 to 0,549), a higher degree of osteoarthritis (P=.048; OR 0,410, 95% CI 0.169 to 0,992), and lower intensity of pain (P<.0001; OR 1,091, 95% CI 1.044 to 1,141), were the factors related with shorter time until surgery. Treatment with viscosupplementation increased the time until surgery in all patients.
CONCLUSIONS: Factors like a lower age of the patient and the involvement of a single joint influenced the referral of the patient to surgery. The administration of viscosupplementation, delayed the time until the patient was finally referred to surgery.
Objetivo: Determinar el efecto del ácido hialurónico intraarticular (HA) de velocidad de la marcha, el dolor y la función, en la artrosis de rodilla mayores (OA) de los pacientes. Materiales y métodos: Treinta pacientes con artrosis de rodilla (Kellgren-Lawrence II-III) [72,44 (± 6,11) años de edad] se asignaron al azar, usando la función 'RANDBETWEEN' en Microsoft Excel, para recibir tres inyecciones semanales de HA (2 ml de 20 mg / ml HA), o placebo (P) (1,2 ml de 0,001 mg / ml HA), con quince participantes por grupo. Los pacientes y los evaluadores fueron cegados al tratamiento. Velocidades de auto-seleccionados y la marcha rápida se midieron con el sistema GAITRite. El dolor de rodilla, la rigidez y la función física se midió con el índice de Western Ontario McMaster Artrosis OA (índice WOMAC OA). Los datos de 1 semana, se analizaron los 3 y 6 meses después del tratamiento usando ANOVA de medidas repetidas. Resultados: El grupo HA mejoraron significativamente auto seleccionado y la velocidad de la marcha rápida, mientras que el grupo P sólo mejoró significativamente la velocidad de la marcha auto-seleccionados. Mejoras en la velocidad de la marcha autoseleccionado media [Media (SD); IC del 95%] [1,25 (52,4) cm / s; -18,38; 20,88] y la velocidad de la marcha rápida [7,16 (71,75) cm / s; -19,72; 34.04] no fueron significativamente diferentes entre los grupos. Las mejoras en las puntuaciones de dolor WOMAC fueron significativamente mayores en el grupo HA que en el grupo P [-2,47 (6,39); -4.86; -0,08], Mientras que las mejoras en la rigidez [-0,87 (2,42); -1.77; 0,04] y la función física [-7,23 (19,77); -14,63; 0.16] Las puntuaciones no lo eran. Conclusiones: El efecto global de HA en velocidad de la marcha en pacientes con artrosis de rodilla de más edad no fue significativa en comparación con el placebo. Los resultados preliminares de la mejora de velocidad de la marcha rápida después del tratamiento HA debe investigarse más, junto con la incidencia de caídas, en una muestra más amplia de pacientes con artrosis de rodilla mayores.ClinicalTrials.gov ID: NCT00778076.
OBJECTIVE: To compare the efficacy of single 6-ml intraarticular injection between hylan G-F 20 and hyaluronic acid (HA) for knee osteoarthritis.
MATERIAL AND METHOD: Thirty-two patients with primary knee arthritis, who were randomly received single intraarticular injection of 6-ml hylan G-F 20 (Synvisc) or HA (Hyalgan), were prospectively evaluated for clinical outcomes at a minimum 26-week follow-up. The parameters, including visual analog scale (VAS) during walking, the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index and Short-Form 36 (SF-36) questionnaires, were evaluated at pre-injection, then at 1 week, 4 weeks, 8 weeks, 12 weeks and 26 weeks, post-injection.
RESULTS: There were 15 patients in both groups who were available for final follow-up with no statistical differences in demographic data, VAS during walking, WOMAC score and SF-36 score at pre-injection. There was no adverse event related to viscosupplementation using in is better than of both agents. At 26-week follow-up, patients in both groups had significantly improved VAS during walking (p < 0.01), WOMAC score (p < 0.01) and SF-36 (p < 0.05) with no statistical differences between groups. However the cost of hylan G-F 20 was much more expensive than that of HA (534 USD vs. 252 USD).
CONCLUSION: A single intraarticular injection of both hylan G-F 20 and HA for primary knee arthritis had no adverse event related to 6-ml volume. At 26-week follow-up of the present preliminary study, both groups had similarly improved clinical outcomes post-injection. Further study in larger population is required. As the cost of hylan G-F 20 was 2 times higher than HA, a single 6-ml intraarticular injection of HA (Hyalgan) provided better cost-effectiveness than hylan G-F 20 (Synvisc).
OBJECTIVE: To estimate the minimum clinically important improvement (MCII) and patient acceptable symptom state (PASS) values for 4 generic outcomes in 5 rheumatic diseases and 7 countries.
METHODS: We conducted a multinational (Australia, France, Italy, Lebanon, Morocco, Spain, and The Netherlands) 4-week cohort study involving 1,532 patients who were prescribed nonsteroidal antiinflammatory drugs for ankylosing spondylitis, chronic back pain, hand osteoarthritis, hip and/or knee osteoarthritis, or rheumatoid arthritis. The MCII and PASS values were estimated with the 75th percentile approach for 4 generic outcomes: pain, patient global assessment, functional disability, and physician global assessment, all normalized to a 0-100 score.
RESULTS: For the whole sample, the estimated MCII values for absolute change at 4 weeks were -17 (95% confidence interval [95% CI] -18, -15) for pain; -15 (95% CI -16, -14) for patient global assessment; -12 (95% CI -13, -11) for functional disability assessment; and -14 (95% CI -15, -14) for physician global assessment. For the whole sample, the estimated PASS values were 42 (95% CI 40, 44) for pain; 43 (95% CI 41, 45) for patient global assessment; 43 (95% CI 41, 44) for functional disability assessment; and 39 (95% CI 37, 40) for physician global assessment. Estimates were consistent across diseases and countries (for subgroups ≥20 patients).
CONCLUSION: This work allows for promoting the use of values of MCII (15 of 100 for absolute improvement, 20% for relative improvement) and PASS (40 of 100) in reporting the results of trials of any of the 5 involved rheumatic diseases with pain, patient global assessment, physical function, or physician global assessment used as outcome criteria.
<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.
ANTECEDENTES: La eficacia y la tolerabilidad de hialuronato de sodio 500-730 kDa (Hyalgan ®) para el tratamiento de la osteoartritis (OA) el dolor se ha establecido en ensayos clínicos, pero hay pocos datos disponibles en la población asiática. Se realizó un estudio aleatorizado, doble ciego, multicéntrico, controlado con placebo para evaluar la eficacia y la tolerabilidad de esta preparación en una población de Taiwán.
MÉTODOS: Doscientos pacientes con insuficiencia renal leve a moderada OA de la rodilla fueron asignados al azar para recibir cinco semanales inyecciones intraarticulares de hialuronato de sodio o placebo. La variable principal de eficacia fue el cambio desde el inicio hasta la semana 25 en la evaluación de los pacientes del dolor con un 100-mm escala analógica visual (VAS) durante la prueba de marcha de 50-pies. Los resultados adicionales incluyen Western Ontario y McMaster Universities (WOMAC) resultados, el tiempo en la prueba de marcha de 50 pies, es paciente y la evaluación subjetiva del investigador de la eficacia, el consumo de paracetamol, y la cantidad de líquido sinovial.
RESULTADOS: La Hyalgan ® grupo de tratamiento mostraron una mejoría significativamente mayor desde el inicio hasta la semana 25 en el dolor VAS en la prueba de marcha de 50 pies que en el grupo placebo (p = 0,0020). El grupo Hyalgan ® reveló mejoras significativas desde el inicio hasta la semana 25 en el dolor WOMAC y puntuación de la función que los del grupo placebo (p = 0,005 y 0,0038, respectivamente) Otras medidas de resultado, como el tiempo en la prueba de marcha de 50 pies y la evaluación subjetiva de la eficacia, no mostró ninguna diferencia significativa entre los grupos. Ambos grupos fueron seguras y bien toleradas.
Conclusiones: El presente estudio sugiere que cinco semanales inyecciones intraarticulares de hialuronato sódico son bien tolerados, pueden proporcionar un alivio sostenido del dolor, y puede mejorar la función en pacientes asiáticos con osteoartritis de la rodilla.
Registro de ensayos: Estudio Terapéutico, Nivel I-1a (ensayo controlado aleatorio con una diferencia significativa).
We retrospectively examined prospective data on the incidence and time to total knee replacement (TKR) in (1) patients with grade IV osteoarthritis (OA) treated with hylan G-F 20 from 1997 to 2010 (full cohort; 1,863 knees) and (2) a patient subset treated from 1997 to 2003 (original cohort; 1,187 knees) to determine any continued hylan G-F 20 influence on TKR delay. In both the cohorts, 25 to 28% knees underwent a TKR, with an average of 2.8 to 3.1 years occurring between hylan G-F 20 and surgery. Age was a significant predictor of time to TKR. Knee synovitis increased slightly with repeat courses; most cases considered mild or moderate. Survival analysis showed that TKR was delayed for > 7 years in 75% of 1,863 grade IV OA knees (1,342 patients) treated with hylan G-F 20 in an orthopedic practice. Consistent with our previous report (Waddell and Bricker, 2007), we show hylan G-F 20 continues to delay the need for TKR.
