BACKGROUND: Intra-articular hyaluronic acid (IAHA) products are often used in the treatment of adults with mild-to-moderate knee osteoarthritis (KOA). The International Symposium on Intra-Articular Treatment (ISIAT) convened a multidisciplinary technical expert panel to define characteristics for an innovative IAHA product that should answer unmet needs in the clinical management of adults with mild-to-moderate KOA. METHODS: An initial set of evidence-based statements was developed based on data extracted from articles identified through a comprehensive literature search. A Delphi panel comprising 19 experts in KOA voted in 3 rounds to rate their degree of agreement with accepted statements. RESULTS: The final set of 13 accepted statements focus on the effect of an innovative IAHA across 5 key domains of nociceptive pain, joint function, quality of life, joint structure and integrity, and adverse effects. The statements set thresholds for clinically meaningful improvements that exceed those generally achievable by currently available IAHA products. CONCLUSION: The characteristics described by these statements from the ISIAT set new standards for what should be expected from an innovative IAHA. These statements should serve as a framework for driving the development of innovative IAHA products that will surpass the actual outcomes achieved by current viscosupplements in patients with mild-to-moderate KOA.
- Klíčová slova
- consensus, innovative, intra-articular hyaluronic acid, knee osteoarthritis,
- Publikační typ
- časopisecké články MeSH
Osteoarthritis (OA) is a significant cause of disability. Considering the increasing diffusion of the viscosupplementation (VS) with hyaluronic acid (HA), the International Symposium Intra Articular Treatment (ISIAT) appointed a Technical Expert Panel (TEP) to identify the criteria for successful VS with a specific HA in OA; this through a systematic literature review (SLR), performed following the PRISMA guidelines interrogating Medline, Embase, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Grey Matters and American College of Rheumatology (ACR/EULAR) databases and the opinion of international experts. The research included only studies on adults and humans without limitations of language or time of publication. Researchers extracted both quantitative and qualitative data from each study. Mixed Methods Appraisal Tool (MMAT) was used to perform quality analysis for the level of evidence. The SLR retrieved 385 papers, 25 of which were suitable for the analysis. The TEP focused on the different formulations of the product Sinovial® [HA 0.8%, HA 1.6%, HA 2%, 800-1200 kDa, HA 3.2% (1400-2100 kDa/65-110 kDa)]. The choice was due to the vast amount of evidence available. The TEP weighed the evidence in two rounds of a Delphi survey; the results, and any disagreement, were discussed in a final session. Three domains were considered: 1) the patients' characteristics associated with the best results; 2) the contraindications and the conditions linked to increased risk of failure; 3) the clinical conditions in which VS is considered appropriate. The TEP concluded that VS with HA is safe and effective in the treatment of knee and hip OA of grades I to III and that it is possible to undertake VS in other situations (eg grade IV Kellgren-Lawrence - KL); a comprehensive examination of the patient should be performed before the procedure.
- Klíčová slova
- appropriateness, osteoarthritis, personalized medicine, viscosupplementation,
- Publikační typ
- časopisecké články MeSH
