NCT07489521

Arthrosemid vs. Steroid for the Management Knee Osteoarthritis

A Randomised Control Trial of the Use of an Intraarticular Hydrogel Arthrosemid® vs. Steroid for the Non-operative Management of Moderate to Severe Osteoarthritis

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Cappagh National Orthopaedic Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Osteo Arthritis Knee
• Osteoarthritis
• Intraarticular Injection

Interventions

Type	Name	Description
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.
DRUG	Steroid Drug	dexamethasone 8mg, methylprednisolone 80mg and bupivacaine 5ml 0.25%, intra articular injection

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2026-03-24
• Last updated: 2026-03-27

Locations

1 site across 1 country: Ireland