A single-blind randomized controlled design intended for the assessment of safety and performance of a single intra-articular injection of the IMD. In the study, 92 patients meeting eligibility criteria will be randomly assigned to two groups respectively of 46 subjects receiving a single injection of the IMD and 46 subjects receiving a single injection of Synvisc-One® (Hylan G-F 20) which is selected as comparator. Each patient will be blinded for the treatment he/she receives at the injection visit (single blinding). The patients will be followed for 12 months post-injection to understand long-term safety and performance effects. The study aims to evaluate the safety and performance of a single injection of KiOmedine® CM-Chitosan compared to the comparator device (Synvisc-One®) in patients with advanced symptomatic knee osteoarthritis. The non-inferiority hypothesis for the primary performance objective is that the percentage mean reduction in pain from baseline at 6 months in the KiOmedine® CM-Chitosan group is non-inferior to that of the comparator group considering a non-inferiority margin. If the hypothesis of non-inferiority is met, then superiority testing will be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
104
KiOmedine® CM-Chitosan is a fluid implant intended for synovial fluid supplementation for the symptomatic treatment of osteoarthritis (OA). This Investigational Medical Device (IMD) is administered via intra-articular injection and is classified as a Class III Device under Council Directive 93/42/EEC (Annex IX, rule 8). A key component of the IMD is a soluble derivative of highly purified chitosan of non-animal origin, an exclusive natural linear glucosamine polysaccharide extracted from the edible white mushroom, Agaricus bisporus. KiOmedine® CM-Chitosan is sterile, non-pyrogenic, resorbable and composed of 2% (w:w) carboxymethyl chitosan (CM-chitosan).
Synvisc-One (Hylan G-F 20) is a sterile, nonpyrogenic, elastoviscous fluid containing Hylan A and Hylan B polymers produced from chicken combs. Hylans are derivatives of hyaluronan (sodium salt of hyaluronic acid) and consist of repeating disaccharide units of N-acetylglucosamine and sodium glucuronate. Hylan A has an average molecular weight of approximately 6,000,000 daltons and hylan B is a hydrated gel. Hylan G-F 20 contains Hylan A and Hylan B (8.0 mg ± 2.0 mg per ml) in buffered physiological sodium chloride solution (pH 7.2 ± 0.3) and is unique in that the hyaluronan is chemically crosslinked.
Hip and Knee Unit
Ghent, Belgium
Percentage change from baseline in knee pain at 6 months post-injection measured by the 5-point Likert WOMAC pain scale.
Time frame: 6 months
Percentage change from baseline in knee pain measured by the 5-point Likert WOMAC pain scale.
Time frame: 2 weeks, 3 months, 9 months and 12 months post-injection.
Percentage change from baseline in knee stiffness measured by the 5-point Likert WOMAC stiffness scale.
Time frame: 2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.
Percentage change from baseline in physical functioning measured by the 5-point Likert WOMAC physical functioning scale.
Time frame: 2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.
Percentage change from baseline in the total WOMAC score.
Time frame: 2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.
Percentage change from baseline in patient's pain and global assessment using an 11-point numerical rating scale.
Time frame: 2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.
Response to treatment according to the Osteoarthritis Research Society International (OARSI) Standing Committee for Clinical Trials Response Criteria Initiative and the Outcome Measures in Rheumatology (OMERACT).
Time frame: 2 weeks, 3 months, 6 months, 9 months and 12 months post-injection.
Treatment responders with >40% improvement from baseline in pain measured by the 5-point Likert WOMAC pain scale.
Time frame: 2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.
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