NCT03060421

Evaluation of the Safety of Intraarticular Aquamid Reconstruction Injection for Knee Osteoarthritis in Humans

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 91 (actual)
• Sponsor: Henning Bliddal · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	Aquamid reconstruction	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.

Timeline

• Start date: 2017-02-27
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2017-02-23
• Last updated: 2025-02-27

Locations

1 site across 1 country: Denmark