KiOmedine^® CM-Chitosan is Effective for Treating Advanced Symptomatic Knee Osteoarthritis up to Six Months Following a Single Intra-Articular Injection: A Post Hoc Analysis of Aproove Clinical Study

Symptomatic knee osteoarthritis (OA) is typically treated with hyaluronan-based intra-articular injections. Advanced knee OA patients are often unresponsive to hyaluronan. KiOmedine^® Carboxymethyl-Chitosan (CM-Chitosan), a novel fluid implant, was safe and effective for treating symptomatic knee OA.

The objective of this study is to describe the efficacy of a single injection of KiOmedine^® CM-Chitosan in advanced knee OA.

Patients with advanced knee OA enrolled in the APROOVE trial and treated with KiOmedine^® CM-Chitosan were identified: subgroup-1, BMI >30 kg/m² and/or Kellgren Lawrence (KL) grade III (n=39), and subgroup-2, BMI >30 kg/m² and KL-grade III (n=8). Within-group analyses were performed using the WOMAC scores and OMERACT-OARSI responder criteria at 3 and 6 months.

In both subgroups, significant improvements in all WOMAC scores were observed at 3 and 6 months (p<0.001 for all comparisons). A high responder rate was observed at 3 and 6 months in subgroup-1 (63.2% and 65.8%) and in subgroup-2 (57.1% and 62.5%).

This post hoc analysis of the APROOVE trial showed that a single intra-articular injection with KiOmedine^® CM-Chitosan could be an effective therapeutic option for patients with advanced knee OA.

Clinical trial registration number: Clinicaltrial.gov

identifier: Net30679208.