Evaluation of the Safety of Intraarticular Aquamid Reconstruction Injection for Knee Osteoarthritis in Humans
1 other identifier
observational
91
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedStudy Start
First participant enrolled
February 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedFebruary 27, 2025
July 1, 2017
4 months
February 17, 2017
February 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Other Outcomes (3)
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Day 1 (at the clinical examination)
Knee joint range of motion
Day 1 (at the clinical examination)
Global perceived effect of treatment
Day 1 (at the clinical examination)
Study Arms (1)
Aquamid Reconstruction
Patients that have been treated with at least one intra-articular injection of aquamid as a treatment of osteoarthritis of the knee
Interventions
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.
Eligibility Criteria
161 participants the total number of patients treated for Knee OA with Aquamid Reconstruction.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henning Bliddallead
Study Sites (1)
The Parker Institute
Copenhagen, 2000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 17, 2017
First Posted
February 23, 2017
Study Start
February 27, 2017
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
February 27, 2025
Record last verified: 2017-07