PAAG-OA Treatment for Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

— IDA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04179552
• Other study ID #: CON-OA
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 21, 2019
• Est. completion date: November 30, 2026

Study information

• Verified date: January 2024
• Source: Contura
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: November 30, 2026
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• PAAG-OA
Intra-articular injection with PAAG-OA (polyacrylamide hydrogel)

Locations

Country	Name	City	State
Denmark	The Parker Institute	Frederiksberg
Denmark	A2 Reumatologi og Idrætsmedicin	Hillerød
Denmark	Reumatolog i Odense	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Contura

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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