Osteo Arthritis KneePhase 4NCT07489521
Arthrosamid vs. Steroid for the Management of Knee Osteoarthritis
A Phase 4 study testing Arthrosamid® 2.5% iPAAG injectable implant and Steroid Drug in people with Osteo Arthritis Knee and Osteoarthritis, run by Cappagh National Orthopaedic Hospital at 1 site in Ireland.
Trial summary
This study will be a randomised control trial of the use of intra-articular Arthrosamid® a novel intraarticular hydrogel vs. standard of care (steroid and local anaesthetic) for the non-operative management of knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee, Osteoarthritis, Intraarticular Injection
- What is being tested?
- Arthrosamid® 2.5% iPAAG injectable implant and Steroid Drug
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIreland
- Study dates
- 29 Jan 2026to Sep 2027
- Phase
- Phase 4
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults
- Symptomatic single side knee pain.
- Patients with diagnosis of knee osteoarthritis radiographic Kellgren and Lawrence system OA grade II-III-IV on x ray or MRI.
Who cannot join
- Inflammatory conditions,
- Cancer,
- acute infection,
- pregnancy and breastfeeding.
- Uncontrolled diabetes mellitus,
- Joint diseases in the knee, such as rheumatoid arthritis or gout, history of knee surgery with metallic implant.
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- If patient has undergone knee arthroscopy in past 6 months.
- Intra-articular injection of corticosteroids during the previous 3 months, intra-articular injection of other drugs, such as hyaluronic acid over the previous 1 year.
- Contraindications for intra-articular injection, such as thrombocytopenia, coagulopathy, articular infection of knee, impairment of immunity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shane Crilly, MD contact
Ireland1 site, 1 recruiting
- Recruiting
Cappagh National Orthopaedic Hospital
Dublin, Dublin, D11 EV29
SEAN TEE LIM, MD, (01) 814 0400, seantee.lim@nohc.ie
Stephen Eustace, MD, (01) 814 0400
About this study
Official title: A Randomised Control Trial of the Use of an Intraarticular Hydrogel Arthrosamid® vs. Steroid for the Non-operative Management of Knee Osteoarthritis
This study will be a randomised control trial of the use of intra-articular Arthrosamid® a novel intraarticular hydrogel vs. standard of care (steroid and local anaesthetic) for the non-operative management of knee osteoarthritis.
Read the detailed description
The authors aim is to study the effect of this intra-articular medication by randomising approximately 100 patients to the treatment arm of the study Arthrosamid, and 100 patients to the control arm (which will be the current standard of care currently provided at CNOH: intra-articular steroid and bupivacaine).
Patients will be referred from Orthopedic clinics and will be eligible if have symptomatic knee pain and arthritis show on prior imaging.
Patients will be given information about the study and given time to choose to be enrolled. They will sign consent forms prior to the study.
They will be randomized into 2 groups. Both will get single knee joint injections into 1 knee. Either Arthrosamid or intra-articular steroid and bupivacaine. They will be blinded to what they have gotten. They will be followed up at 3, 6 , 12 and 18 months with MRI imaging and functional assessment to assess which is better.
- Being tested
- Arthrosamid® 2.5% iPAAG injectable implant, Steroid Drug
- Keywords
- Osteoarthritis, knee, steroid injection
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrosamid® 2.5% iPAAG injectable implantDevice
Arthrosamid is a non-biodegradable, 2.5% polyacrylamide hydrogel (iPAAG) injection designed as a long-lasting, non-surgical treatment for knee osteoarthritis. It acts as a synovial implant that provides cushioning, reduces pain, and improves mobility for up to 3-4 years, often delaying the need for knee replacement surgery.
Steroid DrugDrug
dexamethasone 8mg, methylprednisolone 80mg and bupivacaine 5ml 0.25%, intra articular injection
| Study group | Role | What they receive |
|---|---|---|
| Arthrosamid | Experimental | Patient with knee osteoarthritis
Arthrosamid Injection. This is a non-biodegradable 2.5% iPAAG injectable implant. It is given once. Receives: Device: Arthrosamid® 2.5% iPAAG injectable implant |
| Steroid | Active comparator | Patient with knee osteoarthritis
Steroid arm is as follow with one injection containing:
Dexamethasone 8mg and methylprednisolone 80mg and bupivacaine 0.25% 5 mls. Receives: Drug: Steroid Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Arthritis Index (WOMAC).
Self-administered questionnaire (24 items) assessing pain, stiffness, and physical function in patients with hip or knee osteoarthritis.
Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties
The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
Measured: Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.
Secondary outcomes (3)
MRI knee
MRI of the affected knee with contrast to test for synovitis.
Measured: Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.
EuroQol-5 Dimension-5 Level health questionnaire.
Questionnaire developed by the EuroQol Group to measure health-related quality of life. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
1= no problem, 5 = maximum problems. Example shown below
MOBILITY :
- I have no problems in walking about
- I have slight problems in walking about
- I have moderate problems in walking about
- I have severe problems in walking about
- I am unable to walk about
Measured: Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.
Visual numerical pain rating scale (VNS)
The Visual Numerical Scale (VNS) is a self-reported pain assessment tool that combines a 0-10 numeric scale with visual, pictorial, or graphic aids.
0 = no pain. 10 = worst pain possible
Measured: Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start29 Jan 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Randomised control trial * 2 arms (Control vs. Treatment arm) * Approximately 50-100 patients in each arm * Single injection of standard of care treatment (steroid + local anaesthetic) vs. Arthrosamid. Patients will be randomly assigned to either. Patients identified and referred from orthopedic clinic. Adults with symptomatic knee pain. Patients with diagnosis of knee osteoarthritis radiographic Kellgren and Lawrence system OA grade II-III-IV. Both injections are given once with the patients blinded to which they are getting.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cappagh National Orthopaedic Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Contura
- Responsible party
- Principal investigator, Sean-Tee Lim, Cappagh National Orthopaedic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489521
- Sponsor's protocol ID
- NOHC-2025-ETH-MB-CEO-388
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying published results will be available upon reasonable request following publication, subject to institutional approval and a data sharing agreement.