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Daily Activity and Clinical Outcome Measurement of Arthrosamid® Administration in Symptomatic Knee Osteoarthritis.
Sponsor: Medisch Centrum Latem
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
29
Start Date
2024-07-25
Completion Date
2027-01-31
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
Arthrosamid
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.
Locations (1)
Medisch Centrum Latem
Sint-Martens-Latem, Oost-Vlaanderen, Belgium