Osteoarthritis, Knee
Conditions
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.
Interventions
DEVICEPAAG-OA
Intra-articular injection with PAAG-OA (polyacrylamide hydrogel)
Sponsors
Contura
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged ≥ 18 years 4. Clinical diagnosis of knee OA according to American College of Rheumatology criteria 5. Definite radiographic OA in target knee at mild to severe stage (Kellgren-Lawrence 2-4) 6. Stable dose of analgesics for the past four weeks 7. Score of 2 or more (0-4 scale) on WOMAC question A1 (pain while walking on flat surface) 8. Body Mass Index (BMI) \<35 9. For females of reproductive potential: use of adequate contraception must be used throughout the trial
Exclusion criteria
1. Female participants who are pregnant, lactating or planning pregnancy during the course of the clinical investigation 2. Previous intra-articular injection of polyacrylamide gel in the target knee 3. Previous intra-articular injection with hyaluronic acid or derivatives in target knee in the previous 6 months 4. Significant valgus/varus deformity of the knee, ligamentous laxity or meniscal instability 5. Diseases in target knee other than OA 6. Intra-articular injection of any substance other than hyaluronic acid (e.g. corticosteroids) in the target knee within the last 3 months 7. 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 8. Skin disease or infections in the area of the injection site 9. History of sepsis in any joint or any clinical concern for an infectious process in the target knee 10. History of surgery in the target knee within the past 6 months 11. Symptomatic osteoarthritis of the hips, spine or ankle, that interferes with the evaluation of the target knee 12. Planned surgery on any lower extremity 13. Clinically significant venous of lymphatic stasis present in the legs 14. Suffering from any unstable or severe cardio-vascular disease 15. Any other contraindication to intra-articular injection 16. Any foreign material in the target joint 17. 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 18. Treatment with systemic steroids with daily doses equivalent of \>7,5 mg prednisolone 19. Significant change in physiotherapy in lower extremities related to OA within the previous month 20. Fibromyalgia 21. Inflammatory or other disease/condition which may affect the knee joint (e.g. rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among others) 22. Haemophilia 23. Any other condition that in the opinion of the investigator puts a potential participant at risk or otherwise precludes participation in the investigation 24. Known allergic reactions to antibiotics (azithromycin and moxifloxacin) or local anaesthesia 25. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the WOMAC pain subscale | 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 |
| WOMAC | 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 |
| PGA | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in WOMAC | 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 |
| Change in PGA | 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 |
Countries
Denmark
Outcome results
None listed