PAAG-OA Treatment for Knee Osteoarthritis (IDA)

November 22, 2024 updated by: Contura

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 2000
        • The Parker Institute
      • Hillerød, Denmark
        • A2 Reumatologi og idrætsmedicin
      • Odense, Denmark
        • Reumatolog i Odense

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PAAG-OA
All subjects receive treatment with PAAG-OA
Device: PAAG-OA
Intra-articular injection with PAAG-OA (polyacrylamide hydrogel)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 months
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
1 and 3 months
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
1 and 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
6 and 12 months
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
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Contura

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Henning Bliddal, MD, The Parker Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 7, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CON-OA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings