Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2017-04-21
2019-03-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intra-articular Aquamid Reconstruction
Intra-articular injection of 3 ml aquamid reconstruction (AR) to the knee. A second injection of 3 ml will take place after 1 month (+/- 2 weeks).
Aquamid Reconstruction
AR 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 or effect. AR is biocompatible, non-biodegradable, stable and sterile.
The gel is provided in a sterile, pre-filled 1 ml sealed syringe. The gel is intended to be injected intra-articularly with a sterile 21G x 2 inch (0.8 x 50 mm) needle.
Interventions
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Aquamid Reconstruction
AR 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 or effect. AR is biocompatible, non-biodegradable, stable and sterile.
The gel is provided in a sterile, pre-filled 1 ml sealed syringe. The gel is intended to be injected intra-articularly with a sterile 21G x 2 inch (0.8 x 50 mm) needle.
Eligibility Criteria
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Inclusion Criteria
* WOMAC pain score \>/= 5
* Kellgren and Lawrence radiographic scoring \>/= 1
* Signed informed consent form
Exclusion Criteria
* Actual or recurrent infections requiring intravenous antibiotic treatment within the last 30 days or oral antibiotic treatment within the last 14 days before inclusion
* Less than 12 weeks since injection of HA or corticosteroids in study-knee joint before treatment
* Pregnancy or lactation
* Not able to comply with the requirements of the study
* Previous alloplasty
18 Years
ALL
No
Sponsors
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A2 Reumatologi Og Idrætsmedicin
OTHER
Responsible Party
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Principal Investigators
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Andreas Hartkopp
Role: PRINCIPAL_INVESTIGATOR
A2 Reumatologi of idrætsmedicin
Locations
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A2 reumatologi og idrætsmedicin
Hillerød, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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A2-001
Identifier Type: -
Identifier Source: org_study_id
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