PAAG-OA Treatment for Knee Osteoarthritis (IDA)

• ClinicalTrials.gov Identifier: NCT04179552
• Recruitment Status: Active, not recruiting
• First Posted: November 27, 2019
• Last Update Posted: February 8, 2023
• Sponsor: Contura
• Information provided by (Responsible Party): Contura

Tracking Information

• First Submitted Date: November 22, 2019
• First Posted Date: November 27, 2019
• Last Update Posted Date: February 8, 2023
• Actual Study Start Date: August 21, 2019
• Actual Primary Completion Date: February 7, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 25, 2019)

• 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
• 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
• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 25, 2019)

• Change in WOMAC [ Time Frame: 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 [ Time Frame: 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PAAG-OA Treatment for Knee Osteoarthritis
• Official Title: Prospective, Open-label Clinical Investigation of Intra-articular Polyacrylamide Hydrogel Injection in Subjects With Knee Osteoarthritis
• 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: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Osteoarthritis, Knee

Intervention

Device: PAAG-OA

Intra-articular injection with PAAG-OA (polyacrylamide hydrogel)

Study Arms

Experimental: PAAG-OA

All subjects receive treatment with PAAG-OA

Intervention: Device: PAAG-OA

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 25, 2019): 49
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: November 30, 2026
• Actual Primary Completion Date: February 7, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT04179552
• Other Study ID Numbers: CON-OA
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Contura
• Original Responsible Party: Same as current
• Current Study Sponsor: Contura
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Henning Bliddal, MD; The Parker Institute

• PRS Account: Contura
• Verification Date: February 2023