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

Henning Bliddal

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Device: Aquamid reconstruction

Study type: Observational

Funder types: Other

Identifiers

NCT03060421

P142.0

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously treated with intra-articular Aquamid Reconstruction in the knee for knee osteoarthritis and referred to our clinic for evaluatino of possible adverse device events.

Exclusion criteria

• There are no exclusion criteria

Trial design

91 participants in 1 patient group

Aquamid Reconstruction

Description:

Patients that have been treated with at least one intra-articular injection of aquamid as a treatment of osteoarthritis of the knee

Treatment:

Device: Aquamid reconstruction