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PAAG-OA Treatment for Knee Osteoarthritis (IDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04179552
Recruitment Status : Active, not recruiting
First Posted : November 27, 2019
Last Update Posted : April 21, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: PAAG-OA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Open-label Clinical Investigation of Intra-articular Polyacrylamide Hydrogel Injection in Subjects With Knee Osteoarthritis
Actual Study Start Date : August 21, 2019
Actual Primary Completion Date : February 7, 2020
Estimated Study Completion Date : November 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: PAAG-OA
All subjects receive treatment with PAAG-OA
Device: PAAG-OA
Intra-articular injection with PAAG-OA (polyacrylamide hydrogel)




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04179552


Locations
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Denmark
The Parker Institute
Frederiksberg, Denmark, 2000
A2 Reumatologi og Idrætsmedicin
Hillerød, Denmark
Reumatolog i Odense
Odense, Denmark
Sponsors and Collaborators
Contura
Investigators
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Principal Investigator: Henning Bliddal, MD The Parker Institute
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Responsible Party: Contura
ClinicalTrials.gov Identifier: NCT04179552    
Other Study ID Numbers: CON-OA
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases