OSTEOARTHRITIS
Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: a prospective, multicenter, randomized, double-blind feasibility trial
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2017;5(2):22 BMC Musculoskelet Disord. 2015 Mar 18;16:5798 patients with knee osteoarthritis were randomized to an intra-articular injection of Hydros hyaluronic acid, Hydros plus 10mg triamcinolone acetonide (Hydros-TA), or Synvisc-One hyaluronic acid. The purpose of this study was to compare the effects of Hydros hyaluronic acid, with or without the addition of corticosteroid, to Synvisc-One for patient-reported pain and functional improvement after 2, 6, 13, and 26 weeks using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Results demonstrated no significant differences between the Hydros and Synvisc-One groups, or Hydros-TA and Synvisc-One groups, for the reduction in WOMAC Pain, Stiffness, of Function subscores at any time point.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
4/4
Randomization
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
0/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
Both hyaluronic acid and corticosteroid injections are treatment options for mild to moderate knee osteoarthritis that are commonly used in the management of this condition. While high-quality clinical trials have been conducted to determine if there are benefits of a combining hyaluronic acid and corticosteroid injections a definitive conclusion has not been derived from the literature and the development of novel products that combine these treatments necessitates further research.
主な研究課題は何ですか？
Is there any significant difference between Hydros (hyaluronic acid product), Hydros-TA (hyaluronic acid plus triamcinolone product) and Synvisc-One (hyaluronic acid product) in 26-week efficacy and safety in the treatment of knee osteoarthritis?
重要な知見は？
- The difference in mean reduction in WOMAC Pain subscore was not significant between the Hydros group and the Synvisc-One group at 2 weeks (-23.3+/-5.6 vs. -28.5+/-5.9; p=0.40), 6 weeks (-32.4+/-5.6 vs. -25.6+/-5.9; p=0.28), 13 weeks (-33.9+/-5.6 vs. -29.0+/-6.0; p=0.43), and 26 weeks (-32.4+/-5.6 vs. -28.9+/-6.0; p=0.64).
- The difference in mean reduction in WOMAC Pain subscore was not significant between the Hydros-TA group and the Synvisc-One group at 2 weeks (-35.6+/-5.2 vs. -28.5+/-5.9; p=0.25), 6 weeks (-33.4+/-5.2 vs. -25.6+/-5.9; p=0.21), 13 weeks (-33.3+/-5.2 vs. -29.0+/-6.0; p=0.49), and 26 weeks (-35.2+/-5.3 vs. -28.9+/-6.0; p=0.33).
- Mean reduction in WOMAC Pain subscore was significantly greater in the Hydros-TA group compared to the Hydros group at 2 weeks (p=0.04), with no significant difference between groups at subsequent time points (p>0.05).
- There was also no significant difference between either the Hydros group or the Hydros-TA group compared to the Synvisc-One group in mean reduction in WOMAC Stiffness or Function subscore at 2, 6, 13, or 26 weeks (all p>0.05).
- OMERACT responder rate after 13 weeks was 21/32 (66%) in the Hydros group, 24/34 (71%) in the Hydros-TA group, and 17/32 (53%) in the Synvisc-One group. Responder rate after 26 weeks was 22/32 (69%) in the Hydros group, 22/34 (65%) in the Hydros-TA group, and 19/32 (59%) in the Synvisc-One group.
最も覚えておくべきことは？
In knee osteoarthritis treatment, intra-articular injection with Hydros hyaluronic acid and (Hydro-TA) hyaluronic acid plus triamcinolone acetonide offered no significant differences over a 26-week period for improvement in patient-reported pain and function in comparison to Synvisc-One hyaluronic acid.
それが私の患者ケアにどのように影響するか？
The results of this study suggest that intra-articular injection of either Hydros or Hydros-TA offers a similar reduction in symptomatic knee osteoarthritis pain to that achieved by intra-articular injection of Synvisc-One. There was a short-term benefit observed with the addition of triamcinolone acetonide to Hydros, with greater reduction in pain observed at 2 weeks, though by 6 weeks, differences between Hydros and Hydros-TA groups were non-significant. It is uncertain whether the effect of additional corticosteroid is clinically relevant. Given the phase 2 nature of this study, small group sizes, and lack of placebo group, larger phase 3 trials are needed to ultimately determine the efficacy of Hydros, with or without additional triamcinolone acetonide, in the treatment of knee osteoarthritis.
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