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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-27

Study Completion Date

2017-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Aquamid Reconstruction

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

Aquamid reconstruction

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No