PAAG-OA Treatment for Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Open-label Clinical Investigation of Intra-articular Polyacrylamide Hydrogel Injection in Subjects With Knee Osteoarthritis

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: PAAG-OA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAAG-OA<br>All subjects receive treatment with PAAG-OA | Device: PAAG-OA<br>* Intra-articular injection with PAAG-OA (polyacrylamide hydrogel)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the WOMAC pain subscale | 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 | 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 | 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 | 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 | 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 |