NCT03067090

Aquamid Reconstruction for Osteoarthritis of the Knee

Status unknown NA Last updated 20 June 2018

What this trial tests

NA trial testing Aquamid Reconstruction in Osteoarthritis, Knee in 50 participants. Status unknown.

Timeline

21 April 2017

Primary endpoint
15 September 2018

15 March 2019

Quick facts

Lead sponsor	A2 Reumatologi Og Idrætsmedicin
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	21 April 2017
Primary completion	15 September 2018
Estimated completion	15 March 2019
Sites	1 location across Denmark

Drugs / interventions tested

• Aquamid Reconstruction

Conditions studied

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

Sponsor

A2 Reumatologi Og Idrætsmedicin

Who can join

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

Sponsor's own description

Osteoarthritis (OA) causes degradation and deformities of joints, including knees, hips, hands, and feet. Approximately more than 55% of populations above 45 years and more than 70% of population above 70 years will develop OA in at least one joint. The symptoms are dominated by pain but also stiffness and swelling occur. There is currently no cure for OA, and the ultimate treatment is joint replacement surgery. However, there is an unmet need to identify other treatment options that may delay or avoid surgery.

Aquamid Reconstruction (AR) is a polyacrylamide hydrogel (PAAG) which is a non-degradable, highly visco-elastic synthetic gel, which is atoxic with durable effect and tissue-compatibility and well tolerated by mammal tissue by allowing in vivo vessel and fibrous in-growth. Experimental studies supported by histopathological observations have shown that AR exerts its effect via integration over time within the soft tissues, through a combination of vessel in-growth and molecular water exchange. Intra-articular injection of AR is expected to provide permanent pain relief and improve the functional ability through a cushioning or padding effect on the joint and thereby reduce symptoms and improve patients' quality of life.

The purpose of this study is to obtain information of the safety and effectiveness of AR in patients with OA of the knee.

Publications & conference data

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

1. Translational Applications of Hydrogels.
   Correa S, Grosskopf AK, Lopez Hernandez H, Chan D, et al · · 2021 · cited 575× · PMID 33938724 · DOI 10.1021/acs.chemrev.0c01177
2. Hydrogels in the clinic.
   Mandal A, Clegg JR, Anselmo AC, Mitragotri S. · · 2020 · cited 265× · PMID 32440563 · DOI 10.1002/btm2.10158
3. Current and Future Prospective of Injectable Hydrogels-Design Challenges and Limitations.
   Almawash S, Osman SK, Mustafa G, El Hamd MA. · · 2022 · cited 79× · PMID 35337169 · DOI 10.3390/ph15030371
4. Adhesive hydrogels in osteoarthritis: from design to application.
   Duan WL, Zhang LN, Bohara R, Martin-Saldaña S, et al · · 2023 · cited 46× · PMID 36710340 · DOI 10.1186/s40779-022-00439-3
5. Recent advances in hydrogels applications for tissue engineering and clinical trials.
   Rezakhani L, Gharibshahian M, Salehi M, Zamani S, et al · · 2024 · cited 19× · PMID 39281106 · DOI 10.1016/j.reth.2024.08.015
6. Innovative hydrogel solutions for articular cartilage regeneration: a comprehensive review.
   Kang Y, Guan Y, Li S. · · 2024 · cited 11× · PMID 39236090 · DOI 10.1097/js9.0000000000002076