Arthrosamid versus steroid injections for managing knee osteoarthritis.
Official title: A Randomised Control Trial of the Use of an Intraarticular Hydrogel Arthrosamid® vs. Steroid for the Non-operative Management of Knee Osteoarthritis
Run by Cappagh National Orthopaedic Hospital · NCT07489521 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Cappagh National Orthopaedic Hospital Academic / other |
| Locations | 1 site (Dublin, Dublin) |
| Status | Recruiting |
| Started | January 29, 2026 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | April 28, 2026 |
| Trial ID | NCT07489521 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Evaluating OA-SYS for knee osteoarthritis treatment
This study is testing a new treatment called OA-SYS using adult stem cells to see if it can help people with moderate to severe knee osteoarthritis feel better and improve their knee function.
-
Using patients' own cells to treat osteoarthritis
This study is testing whether using patients' own stem cells and platelet-rich plasma can help treat osteoarthritis better than traditional methods.
-
Autologous adipose-derived stem cell injections for knee osteoarthritis
We’re testing whether injecting a patient’s own fat-derived stem cells into the knee can help people with knee OA feel less pain and move better, compared with a standard hyaluronic acid treatment.
-
Early wear of a Vitamin E-infused liner in a dual-mobility hip replacement
This study tests whether a Vitamin E-infused liner in a dual-mobility hip implant wears as little as a conventional liner over two years in adults needing hip replacement.
-
Preoperative Music to Ease Anxiety Before Hip or Knee Replacement
Patients awaiting hip or knee replacement listen to their own music through noise‑canceling headphones to see if it lowers preoperative anxiety.
-
Weight-bearing dangling exercises vs VMOb NMES for knee osteoarthritis
This study tests whether weighted dangling exercises or VMOb muscle NMES help people with knee osteoarthritis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.