Arthrosamid vs. Steroid for the Management of Knee Osteoarthritis

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis; Osteo Arthritis Knee; Intraarticular Injection
• Intervention / Treatment: Device: Arthrosamid® 2.5% iPAAG injectable implant; Drug: Steroid Drug

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: SEAN TEE LIM, M.D; Phone Number: (01) 814 0400; Email: seantee.lim@nohc.ie
• Study Contact Backup: Name: Shane Crilly, MD; Phone Number: (01) 814 0400

Study Locations

• Ireland
  • Dublin
    • Dublin, Dublin, Ireland, D11 EV29
      • Recruiting
      • Cappagh National Orthopaedic Hospital
      • Principal Investigator: Stephen Eustace, M.D
      • Sub-Investigator: Shane Crilly, M.D
      • Sub-Investigator: Ciara Doran, MSc
      • Contact: SEAN TEE LIM, MD; Phone Number: (01) 814 0400; Email: seantee.lim@nohc.ie
      • Contact: Stephen Eustace, MD; Phone Number: (01) 814 0400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Steroid; Patient with knee osteoarthritis Steroid arm is as follow with one injection containing: Dexamethasone 8mg and methylprednisolone 80mg and bupivacaine 0.25% 5 mls.	Drug: Steroid Drug; dexamethasone 8mg, methylprednisolone 80mg and bupivacaine 5ml 0.25%, intra articular injection
Experimental: Arthrosamid; Patient with knee osteoarthritis Arthrosamid Injection. This is a non-biodegradable 2.5% iPAAG injectable implant. It is given once.	Device: Arthrosamid® 2.5% iPAAG injectable implant; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI knee	MRI of the affected knee with contrast to test for synovitis.	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	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	Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.

Collaborators and Investigators

• Sponsor: Cappagh National Orthopaedic Hospital
• Collaborators: Contura

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Osteoarthritis; knee; steroid injection
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: NOHC-2025-ETH-MB-CEO-388

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available beginning 6 months following publication of the primary results and will remain available for 5 years.
• IPD Sharing Access Criteria: Access to de-identified individual participant data will be provided to qualified researchers upon reasonable request. Requests should include a methodologically sound research proposal and will be subject to approval by the study investigators and the host institution. Data will be shared following execution of a data sharing agreement and in compliance with applicable data protection regulations.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No