Osteoarthritis, Knee
Conditions
Brief 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.
Interventions
DEVICEAquamid 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.
Sponsors
Henning Bliddal
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Device Events | 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
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 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 | 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 | 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. |
Countries
Denmark
Outcome results
None listed