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

NCT03060421 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 91

Last updated 2025-02-27

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee

Interventions

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.

Sponsors & Collaborators

  • Henning Bliddal

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-27
Primary Completion
2017-07-01
Completion
2017-07-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03060421 on ClinicalTrials.gov