As the use of Aquamid Reconstruction as an intraarticular device on humans is a relatively novel treatment, it is relevant to assess the safety profile of the device in a safety study to evaluate the safety of the device. This is a retrospective single center cohort study of patients with osteoarthritis of the knee(s) that have been treated for knee OA referred to a clinical evaluation at our department. The study consists of one clinical visit, at which the patients medical history will be taken and upon informed consent adverse events data is collected from medical records. The study is retrospective.
Study Type
OBSERVATIONAL
Enrollment
91
Aquamid Reconstruction is a Polyacrylamide hydrogel that contains 2.5% polyacrylamide and 97.5% non-pyrogenic water, with a unique molecular structure that allows the normal water exchange with the surrounding tissue without losing shape. Aquamid Reconstruction is biocompatible, non-absorbable non-biodegradable, stable, and sterile. T Aquamid Reconstruction is injected into the knee joint cavity.
The Parker Institute
Copenhagen, Denmark
Adverse Device Events
The investigator will examine each participant for evidence of adverse device events (ADEs) retrospectively by review of medical records and participant interview, and currently by a clinical examination
Time frame: Day 1 (at the clinical examination)
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