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
P.J. Emans1, G. Skaliczki2, D. Haverkamp3, J. Bentin4, M. Chausson5, M. Schifflers5, N. Portelange5, *
Article Information
Identifiers and Pagination:
Year: 2023Volume: 17
E-location ID: e187431292302010
Publisher ID: e187431292302010
DOI: 10.2174/18743129-v16-e220206-2022-19
Article History:
Received Date: 25/10/2022Revision Received Date: 18/01/2023
Acceptance Date: 23/01/2023
Electronic publication date: 14/02/2023
Collection year: 2023
open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract
Background:
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.
Objective:
The objective of this study is to describe the efficacy of a single injection of KiOmedine® CM-Chitosan in advanced knee OA.
Methods:
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.
Results:
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%).
Conclusion:
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.
