Twelve-month efficacy of carboxymethyl-chitosan in refractory knee osteoarthritis: A randomized controlled trial (PIONEER)
Objectives: The 12-month efficacy and safety of a novel bioresorbable fluid implant based on CM-chitosan for intra-articular injection was evaluated in knee osteoarthritis (OA) patients with predictive factors of failure to viscosupplementation. Design: This pilot single-blind randomized controlled...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-06-01
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| Series: | Osteoarthritis and Cartilage Open |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S266591312500041X |
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| author | Philippe Van Overschelde Pieter Vansintjan Nicolas Portelange Mickaël Chausson Wim Weyenberg |
| author_facet | Philippe Van Overschelde Pieter Vansintjan Nicolas Portelange Mickaël Chausson Wim Weyenberg |
| author_sort | Philippe Van Overschelde |
| collection | DOAJ |
| description | Objectives: The 12-month efficacy and safety of a novel bioresorbable fluid implant based on CM-chitosan for intra-articular injection was evaluated in knee osteoarthritis (OA) patients with predictive factors of failure to viscosupplementation. Design: This pilot single-blind randomized controlled study was conducted in 104 patients with at least one of the following OA phenotypes: tricompartmental OA, patellofemoral involvement, K&L grade III or IV and/or body mass index >30 kg/m2. Non-inferiority and superiority of CM-chitosan (KioMedineVSone) in reducing pain were evaluated compared Hylan G-F 20 (Synvisc-One). Efficacy was evaluated using the WOMAC scores, OMERACT-OARSI responder rates, TKA eligibility and events, patient and physician satisfaction. Results: At 6 months post-injection, mean WOMAC pain reduction vs. baseline was 69.4 ± 25.5 % for the CM-chitosan group and 66.3 ± 26.15 % for the Hylan G-F 20 group (non-inferiority p = 0.096; 95 % CI -16.94 %, 7.02 %). At 12 months, significant symptomatic improvement in both groups, with clinically important differences in WOMAC pain reduction in favor of CM-chitosan, were observed, including in the subgroups of patients with patellofemoral OA (Δ 11.5 %), obese patients (Δ 21.7 %) and patients eligible for TKA at baseline (Δ 13.5 %). CM-chitosan showed a high response rate (93.8 %), as well as high patient (93.8 %) and investigator (90.6 %) satisfaction. No new safety signals were identified. Conclusions: In this difficult-to-treat population, CM-chitosan was non-inferior to Hylan G-F 20, but did show clinically important, though not statistically significant, differences in pain reduction at 12 months. CM-chitosan was effective in improving OA symptoms and physical function for 12 months. |
| format | Article |
| id | doaj-art-e37f399138f84e59a563383a38b6abe9 |
| institution | OA Journals |
| issn | 2665-9131 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Osteoarthritis and Cartilage Open |
| spelling | doaj-art-e37f399138f84e59a563383a38b6abe92025-08-20T02:32:54ZengElsevierOsteoarthritis and Cartilage Open2665-91312025-06-017210060510.1016/j.ocarto.2025.100605Twelve-month efficacy of carboxymethyl-chitosan in refractory knee osteoarthritis: A randomized controlled trial (PIONEER)Philippe Van Overschelde0Pieter Vansintjan1Nicolas Portelange2Mickaël Chausson3Wim Weyenberg4Hip & Knee Unit, AZ Maria-Middelares, Gent, BelgiumHip & Knee Unit, AZ Maria-Middelares, Gent, BelgiumKiOmed Pharma, Herstal, BelgiumKiOmed Pharma, Herstal, Belgium; Corresponding author. KiOmed Pharma, 4 rue Haute Claire, 4040, Herstal, Belgium.KiOmed Pharma, Herstal, BelgiumObjectives: The 12-month efficacy and safety of a novel bioresorbable fluid implant based on CM-chitosan for intra-articular injection was evaluated in knee osteoarthritis (OA) patients with predictive factors of failure to viscosupplementation. Design: This pilot single-blind randomized controlled study was conducted in 104 patients with at least one of the following OA phenotypes: tricompartmental OA, patellofemoral involvement, K&L grade III or IV and/or body mass index >30 kg/m2. Non-inferiority and superiority of CM-chitosan (KioMedineVSone) in reducing pain were evaluated compared Hylan G-F 20 (Synvisc-One). Efficacy was evaluated using the WOMAC scores, OMERACT-OARSI responder rates, TKA eligibility and events, patient and physician satisfaction. Results: At 6 months post-injection, mean WOMAC pain reduction vs. baseline was 69.4 ± 25.5 % for the CM-chitosan group and 66.3 ± 26.15 % for the Hylan G-F 20 group (non-inferiority p = 0.096; 95 % CI -16.94 %, 7.02 %). At 12 months, significant symptomatic improvement in both groups, with clinically important differences in WOMAC pain reduction in favor of CM-chitosan, were observed, including in the subgroups of patients with patellofemoral OA (Δ 11.5 %), obese patients (Δ 21.7 %) and patients eligible for TKA at baseline (Δ 13.5 %). CM-chitosan showed a high response rate (93.8 %), as well as high patient (93.8 %) and investigator (90.6 %) satisfaction. No new safety signals were identified. Conclusions: In this difficult-to-treat population, CM-chitosan was non-inferior to Hylan G-F 20, but did show clinically important, though not statistically significant, differences in pain reduction at 12 months. CM-chitosan was effective in improving OA symptoms and physical function for 12 months.http://www.sciencedirect.com/science/article/pii/S266591312500041XKnee osteoarthritisCM-ChitosanIntra-articular injectionRefractory |
| spellingShingle | Philippe Van Overschelde Pieter Vansintjan Nicolas Portelange Mickaël Chausson Wim Weyenberg Twelve-month efficacy of carboxymethyl-chitosan in refractory knee osteoarthritis: A randomized controlled trial (PIONEER) Osteoarthritis and Cartilage Open Knee osteoarthritis CM-Chitosan Intra-articular injection Refractory |
| title | Twelve-month efficacy of carboxymethyl-chitosan in refractory knee osteoarthritis: A randomized controlled trial (PIONEER) |
| title_full | Twelve-month efficacy of carboxymethyl-chitosan in refractory knee osteoarthritis: A randomized controlled trial (PIONEER) |
| title_fullStr | Twelve-month efficacy of carboxymethyl-chitosan in refractory knee osteoarthritis: A randomized controlled trial (PIONEER) |
| title_full_unstemmed | Twelve-month efficacy of carboxymethyl-chitosan in refractory knee osteoarthritis: A randomized controlled trial (PIONEER) |
| title_short | Twelve-month efficacy of carboxymethyl-chitosan in refractory knee osteoarthritis: A randomized controlled trial (PIONEER) |
| title_sort | twelve month efficacy of carboxymethyl chitosan in refractory knee osteoarthritis a randomized controlled trial pioneer |
| topic | Knee osteoarthritis CM-Chitosan Intra-articular injection Refractory |
| url | http://www.sciencedirect.com/science/article/pii/S266591312500041X |
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