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RCT
ACE Report #9368

Efficacy of Hydros HA, with and without corticosteroid, vs. Synvisc for knee OA


Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A

Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: a prospective, multicenter, randomized, double-blind feasibility trial

BMC Musculoskelet Disord. 2015 Mar 18;16:57

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Synopsis

98 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.

Additional Content

This ACE report is part of a significant literature review on corticosteroids.

OrthoEvidence undertook a search to identify clinical practice guidelines, meta-analyses and randomized controlled trials assessing the use of corticosteroids in the treatment of knee osteoarthritis through electronic databases, reviewing the reference list of included publications, and suggestions from experts in the field.

Publication Funding Details +
Funding:
Industry funded
Sponsor:
Carbylan Therapeutics
Conflicts:
Company Employee

Risk of Bias

6.5/10

Reporting Criteria

15/20

Fragility Index

N/A

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)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

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

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

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.

What was the principal research question?

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?

Study Characteristics -
Population:
98 patients, 40-80 years of age, with symptomatic mild to moderate knee osteoarthritis (Kellgren-Lawrence grade II-III). Patients who had received corticosteroid injection within the previous 3 months, or hyaluronic acid injection within the previous 6 months, were excluded.
Intervention:
Hydros group: Patients were treated with a single intraarticular injection of 6mL of Hydros hyaluronic acid product (Carbylan Therapeutics). (n=32; Mean age: 59+/-12) Hydros-TA group: Patients were treated with a single intraarticular injection of 6mL of Hydros (Carbylan Therapeutics) plus 10mg triamcinolone acetonide. (n=34; Mean age: 61+/-11)
Comparison:
Synvisc-One group: Patients were treated with a single intraarticular injection of 6mL Synvisc-One (Genzyme, Sanofi). (n=32; Mean age: 59+/-12)
Outcomes:
The primary efficacy outcome was change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale. Secondary efficacy outcomes included the WOMAC Stiffness and Function subscales, Patient and Physical Global Assessments, and the responder rate using the OMERACT-OARSI criteria (>50% relative or >20pt absolute reduction in WOMAC Pain or Function subscales). Adverse events and treatment-emergent adverse events were recorded and catergorized based on their relation to the study treatment received.
Methods:
RCT; Multicenter, Patient- and Assessor-blind; Phase 2
Time:
Follow-up scheduled for 2, 6, 13, and 26 weeks.

What were the important findings?

  • 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.

What should I remember most?

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.

How will this affect the care of my patients?

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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