Arthrosamid versus steroid injections for managing 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 trial will test whether a single Arthrosamid hydrogel injection works better than a standard steroid plus local anesthetic injection for adults with symptomatic knee osteoarthritis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Cappagh National Orthopaedic Hospital Academic / other |
| Locations | 1 site (Dublin, Dublin) |
| Trial ID | NCT07489521 on ClinicalTrials.gov |
What this trial studies
About 200 adults with symptomatic, radiographically confirmed knee osteoarthritis will be randomized at a single center to receive a single intra-articular injection of either Arthrosamid® hydrogel or the current standard-of-care steroid plus bupivacaine. Participants and outcome assessors will be blinded to treatment allocation, and each participant will receive one injection into the affected knee. Follow-up visits with MRI imaging and functional assessments will occur at 3, 6, 12, and 18 months to compare pain, function, and structural changes. The trial excludes patients with inflammatory arthritis, recent intra-articular treatments, recent knee surgery, contraindications to injection, pregnancy, active infection, or uncontrolled systemic illness.
Who should consider this trial
Good fit: Ideal candidates are adults with symptomatic single-knee osteoarthritis (Kellgren–Lawrence grade II–IV on X-ray or MRI) who have not had recent intra-articular corticosteroids or other injectable therapies and who meet standard safety criteria for joint injection.
Not a fit: Patients with inflammatory joint diseases, active infection, recent knee surgery or injections, pregnancy or breastfeeding, uncontrolled diabetes, or other contraindications to intra-articular injection are unlikely to be eligible or to benefit from this trial.
Why it matters
Potential benefit: If successful, Arthrosamid could provide longer-lasting pain relief and improved knee function compared with steroid injections, potentially delaying the need for surgery.
How similar studies have performed: Hydrogel-based intra-articular implants like Arthrosamid are relatively novel with limited published evidence, while corticosteroid injections are well-established for short-term symptom relief but have variable duration of benefit.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Dublin, Dublin
- Cappagh National Orthopaedic Hospital — Dublin, Dublin, Ireland (Recruiting)
Study contacts
- Study coordinator: Sean Tee Lim, M.d
- Email: seantee.lim@nohc.ie
- Phone: (01) 814 0400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.