Arthrosamid vs. Steroid for the Management of Knee Osteoarthritis
Recruiting · NCT07489521 · Interventional (participants receive a specific treatment) · Lead sponsor: Cappagh National Orthopaedic Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Arthrosamid® 2.5% iPAAG injectable implantSteroid Drug
What this trial is about
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.
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Cappagh National Orthopaedic Hospital - Dublin, Dublin, Ireland