506 Comparative Efficacy and Safety of Two Different Molecular Weight (Mw) Hyaluronans F60027 and Hylan G-F20 in Knee Osteoarthritis (Koa): A Non-Inferiority Randomised Controlled Trial

Maheu, E.; Zaïm, Mohammed; Appelboom, Thierry; Jeka, Sławomir; Trč, Tomáš; Maasalu, Katre; Hucher, M.; Bérenbaum, Francis

doi:10.1016/s1063-4584(09)60527-6

Cited by 25 publications

(49 citation statements)

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“…In addition, most head‐to‐head RCTs performed to date have found noninferiority with respect to symptomatic efficacy between the various HA preparations evaluated . To our knowledge, only 1 RCT was able to demonstrate a statistically significant difference between 2 IAHA preparations varying in MW regarding symptomatic efficacy.…”

Section: Introductionmentioning

confidence: 79%

Use of Intraarticular Hyaluronic Acid in the Management of Knee Osteoarthritis in Clinical Practice

Cooper

Rannou

Richette

et al. 2017

Arthritis Care & Research

121

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Section: Introductionmentioning

confidence: 79%

Use of Intraarticular Hyaluronic Acid in the Management of Knee Osteoarthritis in Clinical Practice

Cooper

Rannou

Richette

et al. 2017

Arthritis Care & Research

121

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“…Corticosteroids had a superior analgesic effect over the first 2 weeks, as expected, but from 8 weeks onwards and in particular 6 months after treatment HA had better pain control, with an effect size up to 0.39. Another meta-analysis10 found no evidence of a clinically relevant benefit of hylan compared with lower MW HA preparations, and a recent trial concluded to the non-inferiority between another intermediate MW HA and hylan G-F20 28. Actually, a study of single intra-articular hylan injection showed only a modest, albeit significant, benefit versus placebo over 6 months on knee pain, with less OARSI/OMERACT responders than with GO-ON in the present trial and a non-significant difference with placebo 29…”

Section: Discussionmentioning

confidence: 99%

A randomised, double-blind, controlled trial comparing two intra-articular hyaluronic acid preparations differing by their molecular weight in symptomatic knee osteoarthritis

Bérenbaum

Grifka

Cazzaniga³

et al. 2012

Annals of the Rheumatic Diseases

122

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ObjectivesTo compare the effects of an intermediate molecular weight (MW) intra-articular hyaluronic acid (HA) with a low MW product on knee osteoarthritis (OA) symptoms.MethodsPatients 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 ratesResultsThe 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.ConclusionsTreatment 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.

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“…1 A metaanalysis of randomized controlled trials comparing hylan to "standard" HA found that patients treated with hylan were approximately twice as likely as patients treated with "standard" HA to experience flares (relative risk of 2.04) and joint effusions (relative risk of 2.40). 23 On the other hand, Maheu et al 11 compared the safety and efficacy of high molecular weight hylan GF-20 to medium molecular weight Structovial and found no difference in local reactions, with no reports of pseudoseptic arthritis in their study. Allergic reaction to avian proteins has been identified as a possible source of the reactions, 5,14 but this may be refuted by similar reactions following the use of non-animal derived HA.…”

Section: Discussionmentioning

confidence: 94%

“…The safety profile of HA is well established, 1 but some concerns have been raised regarding reactions that follow in a limited number of HA patients. [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] These symptoms are generally manifested within several hours to 72 hours after the HA injection, with some occurring 5 to 6 days later. [2][3][4]6,8,9,[12][13][14][17][18][19] Patients may present with severe pain, hot and/or swollen joint, effusion, and loss of function.…”

Section: Introductionmentioning

confidence: 99%

Severe Acute Localized Reactions Following Intra-Articular Hyaluronic Acid Injections in Knee Osteoarthritis

et al. 2020

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Objective Concerns have been raised about severe acute localized reactions (SALR) following intra-articular (IA) hyaluronic acid (HA) injections for knee osteoarthritis (OA). We compared surrogate SALR measures between hylan G-F 20 and non-hylan G-F 20 HA patients and evaluated corresponding SALR risk factors for hylan G-F 20 patients. Design Knee OA patients were identified from the Optum Clinformatics dataset (January 2006 to June 2016), stratified into hylan G-F 20 and non-hylan G-F 20 HA users. Occurrences of surrogate SALR measures including inflammation/infection, intra-articular corticosteroid (CS) injections, arthrocentesis/aspiration, and office visits were evaluated within 3 days of HA use. Risk factors were evaluated using logistic regression. Results The cohort involved 748,428 HA patients (23.2% in the hylan G-F 20 group). Inflammation/infection rate was 0.001% for hylan G-F 20 and 0.002% for non-hylan G-F 20 HA groups. Risk of CS injection (any diagnosis) was greater for hylan G-F 20 patients by 28% ( P < 0.001). Combined rates of CS injection and arthrocentesis/aspiration (any diagnosis) were comparable for both groups (hylan G-F 20, 2.2%; non-hylan G-F 20 HA, 2.6%). The risk of any visit or studied responses was lower for the hylan G-F 20 cohort by 12% ( P < 0.001). Clinical characteristics, such as CS injections within 1 week before HA and fluoroscopic imaging, were associated with the outcomes. Conclusions The diagnosis of inflammations or infections within 3 days of the HA injection was extremely rare. The overall risk of surrogate SALR measures was similar for hylan G-F 20 and non-hylan G-F 20 HA patients.

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506 Comparative Efficacy and Safety of Two Different Molecular Weight (Mw) Hyaluronans F60027 and Hylan G-F20 in Knee Osteoarthritis (Koa): A Non-Inferiority Randomised Controlled Trial

Cited by 25 publications

References 0 publications

Use of Intraarticular Hyaluronic Acid in the Management of Knee Osteoarthritis in Clinical Practice

Use of Intraarticular Hyaluronic Acid in the Management of Knee Osteoarthritis in Clinical Practice

A randomised, double-blind, controlled trial comparing two intra-articular hyaluronic acid preparations differing by their molecular weight in symptomatic knee osteoarthritis

Severe Acute Localized Reactions Following Intra-Articular Hyaluronic Acid Injections in Knee Osteoarthritis

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