NCT03060421

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

Completed Last updated 27 February 2025

What this trial tests

trial testing Aquamid reconstruction in Osteoarthritis, Knee in 91 participants. Completed in 1 July 2017.

Timeline

27 February 2017

Primary endpoint
1 July 2017

1 July 2017

Quick facts

Lead sponsor	Henning Bliddal
Status	Completed
Study type	OBSERVATIONAL
Enrollment	91
Start date	27 February 2017
Primary completion	1 July 2017
Estimated completion	1 July 2017
Sites	1 location across Denmark

Drugs / interventions tested

• Aquamid reconstruction

Conditions studied

• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

Henning Bliddal

Who can join

Eligibility, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hydrogels in the clinic.
   Mandal A, Clegg JR, Anselmo AC, Mitragotri S. · · 2020 · cited 265× · PMID 32440563 · DOI 10.1002/btm2.10158
2. Current and Future Prospective of Injectable Hydrogels-Design Challenges and Limitations.
   Almawash S, Osman SK, Mustafa G, El Hamd MA. · · 2022 · cited 96× · PMID 35337169 · DOI 10.3390/ph15030371
3. Biomedical Application, Patent Repository, Clinical Trial and Regulatory Updates on Hydrogel: An Extensive Review.
   Mohapatra S, Mirza MA, Hilles AR, Zakir F, et al · · 2021 · cited 50× · PMID 34842705 · DOI 10.3390/gels7040207
4. Recent Advances in Clinical Translation of Intra-Articular Osteoarthritis Drug Delivery Systems.
   DeJulius CR, Gulati S, Hasty KA, Crofford LJ, et al · · 2021 · cited 30× · PMID 33709019 · DOI 10.1002/adtp.202000088
5. Polymeric Hydrogels for Controlled Drug Delivery to Treat Arthritis.
   Gupta A, Lee J, Ghosh T, Nguyen VQ, et al · · 2022 · cited 27× · PMID 35335915 · DOI 10.3390/pharmaceutics14030540
6. Hydrogel Films in Biomedical Applications: Fabrication, Properties and Therapeutic Potential.
   Sutradhar SC, Shin H, Kim W, Jang H. · · 2025 · PMID 41294603 · DOI 10.3390/gels11110918