Safety and clinical performance of intra-articular high-purity sodium hyaluronate injection in patients with knee osteoarthritis: a 28-week post-market clinical follow-up study.

ABSTRACT:

Objectives

Intra-articular hyaluronic acid (HA) is a widely used treatment for knee osteoarthritis (OA), offering localized symptomatic relief with minimal systemic exposure. This post-market clinical follow-up (PMCF) study aimed to evaluate the safety and clinical performance of a high-purity sodium hyaluronate formulation in a real-world population with symptomatic knee OA.

Methods

In this prospective, single-arm, open-label post-market follow-up study, 65 patients with radiographically confirmed knee OA received three weekly intra-articular injections of a high-purity sodium hyaluronate formulation (1.5%, 15 mg/mL). Patients were followed through Week 28. The primary outcome was safety, assessed by adverse event (AE) monitoring and vital signs. Secondary assessments inclu

SUBMITTER: Chen CF 

PROVIDER: S-EPMC12923421 | biostudies-literature | 2026 Mar

REPOSITORIES: biostudies-literature