- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04179552
PAAG-OA Treatment for Knee Osteoarthritis (IDA)
January 4, 2024 updated by: Contura
Prospective, Open-label Clinical Investigation of Intra-articular Polyacrylamide Hydrogel Injection in Subjects With Knee Osteoarthritis
This is a multi-centre, prospective, open-label, uncontrolled, clinical investigation followed by an open-label extension clinical investigation to evaluate PAAG-OA in patients with knee osteoarthritis.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a multi-centre, prospective, open-label clinical trial consisting of a main study followed by an extension study.
The study will evaluate the effectiveness and safety of intra-articular polyacrylamide hydrogel (PAAG-OA) in subjects with knee OA.
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Frederiksberg, Denmark, 2000
- The Parker Institute
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Hillerød, Denmark
- A2 Reumatologi og idrætsmedicin
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Odense, Denmark
- Reumatolog i Odense
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥ 18 years
- Clinical diagnosis of knee OA according to American College of Rheumatology criteria
- Definite radiographic OA in target knee at mild to severe stage (Kellgren-Lawrence 2-4)
- Stable dose of analgesics for the past four weeks
- Score of 2 or more (0-4 scale) on WOMAC question A1 (pain while walking on flat surface)
- Body Mass Index (BMI) <35
- For females of reproductive potential: use of adequate contraception must be used throughout the trial
Exclusion Criteria:
- Female participants who are pregnant, lactating or planning pregnancy during the course of the clinical investigation
- Previous intra-articular injection of polyacrylamide gel in the target knee
- Previous intra-articular injection with hyaluronic acid or derivatives in target knee in the previous 6 months
- Significant valgus/varus deformity of the knee, ligamentous laxity or meniscal instability
- Diseases in target knee other than OA
- Intra-articular injection of any substance other than hyaluronic acid (e.g. corticosteroids) in the target knee within the last 3 months
- Acute serious infection of any region that required hospital care or intravenous antibiotic treatment within the last 30 days, or oral antibiotic treatment within the last 14 days
- Skin disease or infections in the area of the injection site
- History of sepsis in any joint or any clinical concern for an infectious process in the target knee
- History of surgery in the target knee within the past 6 months
- Symptomatic osteoarthritis of the hips, spine or ankle, that interferes with the evaluation of the target knee
- Planned surgery on any lower extremity
- Clinically significant venous of lymphatic stasis present in the legs
- Suffering from any unstable or severe cardio-vascular disease
- Any other contraindication to intra-articular injection
- Any foreign material in the target joint
- Any significant medical condition (e.g. significant psychiatric or neurological disorders or active alcohol/drug abuse) that is unstable/poorly controlled or other factors that may interfere with study participation
- Treatment with systemic steroids with daily doses equivalent of >7,5 mg prednisolone
- Significant change in physiotherapy in lower extremities related to OA within the previous month
- Fibromyalgia
- Inflammatory or other disease/condition which may affect the knee joint (e.g. rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among others)
- Haemophilia
- Any other condition that in the opinion of the investigator puts a potential participant at risk or otherwise precludes participation in the investigation
- Known allergic reactions to antibiotics (azithromycin and moxifloxacin) or local anaesthesia
- Participation in any experimental device study within 6 months prior to enrolment, or participation in an experimental drug study within 1 month prior to enrolment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PAAG-OA
All subjects receive treatment with PAAG-OA
|
Intra-articular injection with PAAG-OA (polyacrylamide hydrogel)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the WOMAC pain subscale
Time Frame: 3 months
|
To evaluate the effectiveness of one injection of PAAG-OA on pain over 3 months in subjects with mild to severe knee OA.
Change in WOMAC (WOMAC Osteoarthritis Index) pain subscale where a score of 0=none, and 4=extreme
|
3 months
|
WOMAC
Time Frame: 1 and 3 months
|
To evaluate the effectiveness of one injection of PAAG-OA on knee OA-related subject reported symptoms, function during activities of daily living.
Change in WOMAC (WOMAC Osteoarthritis Index) pain subscale where a score of 0=none, and 4=extreme
|
1 and 3 months
|
PGA
Time Frame: 1 and 3 months
|
To evaluate the effectiveness of one injection of PAAG-OA on knee OA Patient Global Assessment (PGA).
PGA is reported on a 10 cm Visual Analogue Scale
|
1 and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in WOMAC
Time Frame: 6 and 12 months
|
To evaluate the extended effectiveness of 6 ml PAAG-OA on knee OA-related subject reported symptoms, function during activities of daily living over 6 and 12 months.
Change in WOMAC (WOMAC Osteoarthritis Index) pain subscale where a score of 0=none, and 4=extreme
|
6 and 12 months
|
Change in PGA
Time Frame: 6 and 12 months
|
To evaluate the extended effectiveness of 6 ml PAAG-OA on knee OA-related Patient Global Assessment (PGA) over 6 and 12 months.
PGA is reported on a 10 cm Visual Analogue Scale
|
6 and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Henning Bliddal, MD, The Parker Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 21, 2019
Primary Completion (Actual)
February 7, 2020
Study Completion (Estimated)
November 30, 2026
Study Registration Dates
First Submitted
November 22, 2019
First Submitted That Met QC Criteria
November 25, 2019
First Posted (Actual)
November 27, 2019
Study Record Updates
Last Update Posted (Estimated)
January 8, 2024
Last Update Submitted That Met QC Criteria
January 4, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CON-OA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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