Arthrosamid vs. Steroid for the Management of Knee Osteoarthritis

Sponsor
Cappagh National Orthopaedic Hospital
Study ID
NCT07489521
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Arthrosamid® 2.5% iPAAG injectable implant — DEVICE
    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 Drug — DRUG
    dexamethasone 8mg, methylprednisolone 80mg and bupivacaine 5ml 0.25%, intra articular injection

Study Details

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.

Key Dates

First listed
Mar 24, 2026
Start date
Jan 29, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arthrosamid
    Patient with knee osteoarthritis Arthrosamid Injection. This is a non-biodegradable 2.5% iPAAG injectable implant. It is given once.
  • 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.

Primary Outcome Measure

Western Ontario and McMaster Universities Arthritis Index (WOMAC). [ Time Frame: Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months. ]

Central Contacts

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