RecruitingPhase 4NCT07489521

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


Sponsor

Cappagh National Orthopaedic Hospital

Enrollment

200 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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.

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Interventions

DEVICEArthrosamid® 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.

DRUGSteroid Drug

dexamethasone 8mg, methylprednisolone 80mg and bupivacaine 5ml 0.25%, intra articular injection


Locations(1)

Cappagh National Orthopaedic Hospital

Dublin, Dublin, Ireland

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NCT07489521


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