This study is a prospective, monocentric, interventional post-market study evaluating the effects of a single intra-articular injection of Arthrosamid in patients with symptomatic knee osteoarthritis. Arthrosamid is a polyacrylamide hydrogel consisting of 97.5% sterile water and 2.5% cross-linked polyacrylamide that integrates into the synovial tissue and is used for the symptomatic treatment of knee osteoarthritis. The study will include 30 eligible patients receiving a single Arthrosamid injection and will be followed for up to 12 months. The primary objective is to evaluate the performance of Arthrosamid in terms of daily activities and clinical outcomes in patients with symptomatic knee osteoarthritis. The primary endpoint assesses the percentage change from baseline in daily activity levels at 6 months after injection, measured using an activity tracker combined with a digital rehabilitation tool. Additional assessments include patient-reported outcome measures and clinical follow-up visits conducted as part of standard care.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Single intra-articular injection of Arthrosamid, a polyacrylamide hydrogel consisting of 97.5% sterile water and 2.5% cross-linked polyacrylamide, administered for the symptomatic treatment of knee osteoarthritis.
Medisch Centrum Latem
Sint-Martens-Latem, Oost-Vlaanderen, Belgium
Percentage Change From Baseline in Daily Activity Levels
Percentage change from baseline in daily activity levels at 6 months after a single intra-articular Arthrosamid injection, measured using an activity tracker coupled with a digital rehabilitation tool.
Time frame: 6 months follow-up
Percentage Change From Baseline in Daily Activity Levels
Percentage change from baseline in daily activity levels at 12 months after a single intra-articular Arthrosamid injection, measured using an activity tracker coupled with a digital rehabilitation tool.
Time frame: 12 months follow-up
Change From Baseline in Patient-Reported Outcome Measures
Absolute and percentage change from baseline in patient-reported outcome measures (PROMs), including KOOS (total and subscales), Oxford Knee Score, Forgotten Joint Score (FJS), EQ-5D, UCLA Activity Score, and the moveUP index score, in patients with symptomatic knee osteoarthritis treated with Arthrosamid.
Time frame: 7 to 14 days before injection, Day 0 (baseline), 2 weeks, 6 weeks, 3 months, 6 months, and 12 months follow-up
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