Clinical trial NCT03067090: Aquamid Reconstruction for Osteoarthritis of the Knee
Official title: Prospective Study of Aquamid Reconstruction in Patients With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: A2 Reumatologi Og Idrætsmedicin
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* WOMAC pain score \>/= 5
* Kellgren and Lawrence radiographic scoring \>/= 1
* Signed informed consent form

Exclusion Criteria:

* Other diseases affecting the joints such as rheumatoid arthritis
* 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

Primary outcomes:
measure: Change from baseline in the pain subscore of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in all subscores of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 3, 6 and 12 months
measure: Participants' percieved effect
timeFrame: 1, 3, 6, and 12 months
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: A2 reumatologi og idrætsmedicin
Study officials:
affiliation: A2 Reumatologi of idrætsmedicin
name: Andreas Hartkopp
role: PRINCIPAL_INVESTIGATOR
References: