This is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee osteoarthritis who is eligible for treatment with Arthrosamid® according to the Instruction for Use.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged ≥ 18 years
* Clinical diagnosis of knee OA
Exclusion Criteria:
* If an active skin disease or infection is present at or near the injection site
* If the joint is infected or severely inflamed
* If a degradable intra-articular injectable such as hyaluronic acid is present, it must be expected to be absorbed according to manufacturer's information for the specific product, before injection with Arthrosamid®
* If the patient has previously received treatment with a different non-absorbable injectable/implant
* If the patient has received a knee alloplasty or has any foreign material in the knee
* If the patient has undergone knee arthroscopy within the last 6 months
* If the patient has haemophilia or is in uncontrolled anticoagulant treatment
Primary outcome measure(s)
Number of adverse events — 5 years The total number of treatment emergent adverse events
Trial sites (9)
Facility
City
Region
Status
The Parker Institute
Copenhagen
Denmark
Reumatolog i Odense
Odense
Denmark
AP-HM hopitaux
Marseille
France
Clinique Saint Louis
Poissy
France
AmBeNet Hausarztpraxis
Leipzig
Germany
University Medical Center of Johannes Gutenberg-University Mainz (UMC-Mainz)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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