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

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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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

The Parker Institute

Copenhagen, 2000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aquamid reconstruction

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.

Primary outcomes

Adverse Device Events

Time frame: Day 1 (at the clinical examination)

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

Other outcomes

Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Time frame: Day 1 (at the clinical examination)

The WOMAC is a patient reported questionnaire that is easy to use and evaluates three domains; pain (five questions), stiffness (two questions) and physical function (17 questions), each weighted on a similar computation. The WOMAC Index is sensitive to change and is valid for elderly subjects with knee OA.

To obtain the WOMAC scores, we apply the Knee Injury and Osteoarthritis Outcome Score (KOOS). The KOOS includes WOMAC Osteoarthritis Index LK 3.0 in its complete and original format (with permission), and WOMAC scores can be calculated (how to calculate WOMAC scores is presented in the document "KOOS scoring", available from www.koos.nu).
Knee joint range of motion

Time frame: Day 1 (at the clinical examination)

A clinical evaulation of knee joint range of motion. Will scored as 'normal' or 'reduced'
Global perceived effect of treatment

Time frame: Day 1 (at the clinical examination)

The participants will also answer a transition questionnaire on which the participants initially answers if their current state is "unchanged, worse" or "better" compared to the pre-injection status. An "unchanged" equals a transition score of 0. If the participant answers "worse", he/she is asked to rate the degree of worsening on a 7 point Likert scale, and the corresponding scores range from -1 to -7. Correspondingly, if a participant answers "better", he/she is asked to rate the degree of improvement on a 7 point Likert scale, and the corresponding scores range from 1 to 7. Thus the Transition score range from -7 (worsening) to 7 (improvement), with the mid-point - 0 - representing no change.

Sponsors and collaborators

Lead sponsor

Henning Bliddal

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Feb 23, 2017
Registry last updated: Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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