Osteoarthritis, KneeIDANCT04179552
PAAG-OA Treatment for Knee Osteoarthritis
A study testing PAAG-OA in people with Osteoarthritis, Knee, run by Contura at 3 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- PAAG-OA
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 3 sitesDenmark
- Study dates
- 21 Aug 2019to 19 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥ 18 years
- Clinical diagnosis of knee OA according to American College of Rheumatology criteria
- Definite radiographic OA in target knee at mild to severe stage (Kellgren-Lawrence 2-4)
- Stable dose of analgesics for the past four weeks
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- Score of 2 or more (0-4 scale) on WOMAC question A1 (pain while walking on flat surface)
- Body Mass Index (BMI) <35
- For females of reproductive potential: use of adequate contraception must be used throughout the trial
Who cannot join
- Female participants who are pregnant, lactating or planning pregnancy during the course of the clinical investigation
- Previous intra-articular injection of polyacrylamide gel in the target knee
- Previous intra-articular injection with hyaluronic acid or derivatives in target knee in the previous 6 months
- Significant valgus/varus deformity of the knee, ligamentous laxity or meniscal instability
- Diseases in target knee other than OA
- Intra-articular injection of any substance other than hyaluronic acid (e.g. corticosteroids) in the target knee within the last 3 months
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- 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
- Skin disease or infections in the area of the injection site
- History of sepsis in any joint or any clinical concern for an infectious process in the target knee
- History of surgery in the target knee within the past 6 months
- Symptomatic osteoarthritis of the hips, spine or ankle, that interferes with the evaluation of the target knee
- Planned surgery on any lower extremity
- Clinically significant venous of lymphatic stasis present in the legs
- Suffering from any unstable or severe cardio-vascular disease
- Any other contraindication to intra-articular injection
- Any foreign material in the target joint
- 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
- Treatment with systemic steroids with daily doses equivalent of >7,5 mg prednisolone
- Significant change in physiotherapy in lower extremities related to OA within the previous month
- Fibromyalgia
- Inflammatory or other disease/condition which may affect the knee joint (e.g. rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among others)
- Haemophilia
- Any other condition that in the opinion of the investigator puts a potential participant at risk or otherwise precludes participation in the investigation
- Known allergic reactions to antibiotics (azithromycin and moxifloxacin) or local anaesthesia
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
The Parker Institute
Frederiksberg, 2000
A2 Reumatologi og Idrætsmedicin
Hillerød
Reumatolog i Odense
Odense
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- PAAG-OA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAAG-OADevice
Intra-articular injection with PAAG-OA (polyacrylamide hydrogel)
| Study group | Role | What they receive |
|---|---|---|
| PAAG-OA | Experimental | All subjects receive treatment with PAAG-OA Receives: Device: PAAG-OA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
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
Measured: 1 and 3 months
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
Measured: 1 and 3 months
Secondary outcomes (2)
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
Measured: 6 and 12 months
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
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start21 Aug 2019
- Primary completion7 Feb 2020
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contura
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henning Bliddal, MD, Principal investigator, The Parker Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179552
- Sponsor's protocol ID
- CON-OA
- Acronym
- IDA
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2019
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bliddal H, Hartkopp A, Beier J, Conaghan PG, Henriksen M. A prospective, open-label, clinical investigation of a single intra-articular polyacrylamide hydrogel injection in participants with knee osteoarthritis: a 5-year extension study. J Orthop Surg Res. 2025 Dec 12;21(1):43. doi: 10.1186/s13018-025-06526-0.
PubMed 41387884Bliddal H, Beier J, Hartkopp A, Conaghan PG, Henriksen M. Effectiveness and safety of polyacrylamide hydrogel injection for knee osteoarthritis: results from a 12-month follow up of an open-label study. J Orthop Surg Res. 2024 May 2;19(1):274. doi: 10.1186/s13018-024-04756-2.
PubMed 38698396
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-label Clinical Investigation of Intra-articular Polyacrylamide Hydrogel Injection in Subjects With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04179552
- Acronym / sponsor ID
- IDA / CON-OA
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- ConturaIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAAG-OA | Experimental | Device: PAAG-OAAll subjects receive treatment with PAAG-OA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥ 18 years
- Clinical diagnosis of knee OA according to American College of Rheumatology criteria
- Definite radiographic OA in target knee at mild to severe stage (Kellgren-Lawrence 2-4)
Key exclusion criteria (25 listed)
- Female participants who are pregnant, lactating or planning pregnancy during the course of the clinical investigation
- Previous intra-articular injection of polyacrylamide gel in the target knee
- Previous intra-articular injection with hyaluronic acid or derivatives in target knee in the previous 6 months
- Significant valgus/varus deformity of the knee, ligamentous laxity or meniscal instability
- Diseases in target knee other than OA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAAG-OAIntra-articular injection with PAAG-OA (polyacrylamide hydrogel) | Device | PAAG-OA |
Primary outcome
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
2 secondary outcomes
Change in WOMAC
Time frame: 6 and 12 months
Change in PGA
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Derived from this study: PubMed 41387884Bliddal H, Hartkopp A, Beier J, Conaghan PG, Henriksen M. A prospective, open-label, clinical investigation of a single intra-articular polyacrylamide hydrogel injection in participants with knee osteoarthritis: a 5-year extension study. J Orthop Surg Res. 2025 Dec 12;21(1):43. doi: 10.1186/s13018-025-06526-0.
- Derived from this study: PubMed 38698396Bliddal H, Beier J, Hartkopp A, Conaghan PG, Henriksen M. Effectiveness and safety of polyacrylamide hydrogel injection for knee osteoarthritis: results from a 12-month follow up of an open-label study. J Orthop Surg Res. 2024 May 2;19(1):274. doi: 10.1186/s13018-024-04756-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henning Bliddal, MD principal investigator
The Parker Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAAG-OA in people with Osteoarthritis, Knee, run by Contura at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the WOMAC pain subscale (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04179552, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.