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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aquamid Reconstruction | Patients that have been treated with at least one intra-articular injection of aquamid as a treatment of osteoarthritis of the knee |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Device Events | 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 | Day 1 (at the clinical examination) |
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| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 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). |
Inclusion Criteria:
Exclusion Criteria:
- There are no exclusion criteria
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161 participants the total number of patients treated for Knee OA with Aquamid Reconstruction.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Parker Institute | Copenhagen | 2000 | Denmark |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Day 1 (at the clinical examination) |
| Knee joint range of motion | A clinical evaulation of knee joint range of motion. Will scored as 'normal' or 'reduced' | Day 1 (at the clinical examination) |
| Global perceived effect of treatment | 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. | Day 1 (at the clinical examination) |
| D012216 |
| Rheumatic Diseases |