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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060421
• Other study ID #: P142.0
• Status: Completed
• Phase: N/A
• First received: February 17, 2017
• Last updated: July 31, 2017
• Start date: February 27, 2017
• Est. completion date: July 1, 2017

Study information

• Verified date: July 2017
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Denmark	The Parker Institute	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Henning Bliddal

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	Day 1 (at the clinical examination)
Other	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)
Other	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)
Primary	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)