PAAG-OA Treatment for Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Device: PAAG-OA

• Registration Number: NCT04179552
• Lead Sponsor: Contura

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.

Study Timeline

• Study Start: 2019-08-21
• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-27
• Primary Completion: 2020-02-07
• Study Completion: 2024-09-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PAAG-OA	PAAG-OA	All subjects receive treatment with PAAG-OA

Primary Outcome Measures

Name	Time	Method
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
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

A2 Reumatologi og Idrætsmedicin; 🇩🇰 Hillerød, Denmark

Reumatolog i Odense; 🇩🇰 Odense, Denmark

The Parker Institute; 🇩🇰 Frederiksberg, Denmark