Aquamid Reconstruction for Osteoarthritis of the Knee

NCT03067090 | Unknown DMC

• 1 other identifier: A2-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the pain subscore of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  The WOMAC is a patient reported questionnaire that is easy to use and evaluates three domains; pain (five questions), stiffness (two questions) and physical function (17 questions), each weighted on a similar computation. The WOMAC Index is sensitive to change and is valid for elderly subjects with knee OA.

  6 months

Secondary Outcomes (2)

• Change from baseline in all subscores of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  3, 6 and 12 months

• Participants' percieved effect

  1, 3, 6, and 12 months

Study Arms (1)

Intra-articular Aquamid Reconstruction

EXPERIMENTAL

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).

Device: Aquamid Reconstruction

Interventions

Aquamid Reconstruction DEVICE

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.

Intra-articular Aquamid Reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Other diseases affecting the joints such as rheumatoid arthritis
• 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

Sponsors & Collaborators

• A2 Reumatologi Og Idrætsmedicin: lead

Study Sites (1)

A2 reumatologi og idrætsmedicin

Hillerød, 3400, Denmark

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Andreas Hartkopp

  A2 Reumatologi of idrætsmedicin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Hartkopp, MD, PhD

CONTACT

+45 48200530; ah@a2privathospital.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 1, 2017
• Study Start: April 21, 2017
• Primary Completion: September 15, 2018
• Study Completion: March 15, 2019
• Last Updated: June 20, 2018

Record last verified: 2018-06

Locations

DK (1)