Prospective, Open-label Clinical Investigation of Intra-articular Polyacrylamide Hydrogel Injection in Subjects With Knee Osteoarthritis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Contura
- Enrollment
- 49
- Locations
- 3
- Primary Endpoint
- PGA
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
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
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
Secondary Outcomes
- Change in WOMAC(6 and 12 months)
- Change in PGA(6 and 12 months)