Medisch Centrum Latem
Sint-Martens-Latem, Oost-Vlaanderen, 9830, Belgium
NCT Number: NCT07465601
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Sint-Martens-Latem, Oost-Vlaanderen, 9830, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months follow-up
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: 12 months follow-up
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: 7 to 14 days before injection, Day 0 (baseline), 2 weeks, 6 weeks, 3 months, 6 months, and 12 months follow-up
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: 2 weeks, 6 weeks, 3 months, 6 months, and 12 months follow-up
Consumption of concomitant or rescue medication in patients with symptomatic knee osteoarthritis following a single intra-articular Arthrosamid injection, assessed at multiple follow-up time points.
Medisch Centrum Latem
Other
Evaluation of Daily Activity and Clinical Outcomes After a Single, Intra-articular, Injection of Arthrosamid® in Patients With Symptomatic Knee Osteoarthritis: a Monocentric Trial With a 12-month Follow-up Period
Acronym: ACTA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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