Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT04693104
Brief Summary:
This multicentre, prospective, randomized, double-blind, active-controlled, parallel group clinical investigation is aimed to assess the safety and the clinical performance over 6 months of a single intra-articular injection of PVA Hydrogel, novel polyvinyl alcohol preparation, as compared to hyalan G-F20, (Synvisc-One®) one of the most commonly used and best performing hyaluronic acid based products, in patients with symptomatic knee osteoarthitis (OA).
Detailed Description:
To compare the effects of a single intra-articular injection of a novel polyvinyl alcohol preparation (PVA Hydrogel) and hylan G-F20 (Synvisc-One®) in patients with symptomatic knee OA.
Patients with knee OA (ACR clinical and radiological criteria) symptoms for ≥6 months, insufficient/failed response to analgesics, K\&L stage II-III (x-Rays within past 12 months), a knee pain score of 4-9 (0-10 NRS) in the target knee and \<3 in the contralateral knee, will be enrolled in a randomised, controlled, double-blind, parallel group 26-week clinical investigation to receive a single intra-articular injection of PVA Hydrogel or Synvisc-One®. Safety (both at the injection site (primary end-point) and overall) and efficacy (change in pain in the target knee (0-10 NRS), WOMAC Osteoarthritis Index (total and subscales) and Patient's Global Assessment of knee OA (0-10 NRS)) will be evaluated.
After signing an informed consent, patients will be screened at least 7 days before randomisation, when they will received a single intra-articular injection of either PVA Hydrogel or Synvisc-One® (1:1 allocation ratio) and will be then seen for follow-up 1, 2 and 4 days (this latter just in case of AE occurrence at the target knee) and 2, 4, 8, 12, 18 and 26 weeks after IA injection.
Study:
NCT04693104
Study Brief:
Protocol Section:
NCT04693104