ArticleClinical pharmacology : advances and applications2021
An Investigator-Initiated, Prospective, Single-Center, Open-Label Clinical Study to Evaluate Safety and Performance of Intra-Articular Hyaluronic Acid (IA-HA) (Biovisc Ortho) in Patients with Osteoarthritis (OA) of the Knee.
Article in Clinical pharmacology : advances and applications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed.
- Safety of intra-articular corticosteroid and hyaluronic acid injections: a 14-year population-based cohort study of 404,797 patients.BMC musculoskeletal disorders · 2026Article
- Long-term functional and clinical outcomes of intraarticular double-cross-linked high molecular weight hyaluronic acid (Crespine Gel Plus) injection in knee osteoarthritis: a one year prospective study.BMC musculoskeletal disorders · 2026Article
- Clinical and radiological efficacy of single-dose intra-articular high-molecular-weight hyaluronic acid in knee osteoarthritis.Journal of family medicine and primary care · 2023Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveIA-HA is injected into the osteoarthritis knee as a viscosupplementation for therapeutic purposes. This clinical trial was carried out for evaluating the efficacy and safety of Biovisc Ortho IA-HA (20 mg/2 mL) in a 2 mL prefilled syringe.
designThe study was conducted as an open-label, single-center, single-arm clinical trial in India. Patients of knee OA with moderate to severe symptoms for a minimum duration of 3 months were included in the study. Five visits were conducted at weekly intervals and the investigational product was administered at each visit. Two follow-up visits were conducted at 3 and 6 months after the completion of the last injection cycle. The primary outcome variable was change in KOOS pain score from baseline. The secondary outcome variables were analyzed for other KOOS scales and safety of the device.
resultsChange in KOOS pain score at 6 months from baseline was 29.71±15.74 and the change in mean KOOS score for pain was statistically significant (
conclusionDespite being an open, noncomparative study, the safety and efficacy results of IA-HA establish the therapeutic effect of the treatment throughout the study period of 6 months and are safe.
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