Osteo Arthritis Knee, Osteoarthritis, Intraarticular Injection
Conditions
Keywords
Osteoarthritis, knee, steroid injection
Brief 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.
Detailed description
The authors aim is to study the effect of this intra-articular medication by randomising approximately 100 patients to the treatment arm of the study Arthrosamid, and 100 patients to the control arm (which will be the current standard of care currently provided at CNOH: intra-articular steroid and bupivacaine). Patients will be referred from Orthopedic clinics and will be eligible if have symptomatic knee pain and arthritis show on prior imaging. Patients will be given information about the study and given time to choose to be enrolled. They will sign consent forms prior to the study. They will be randomized into 2 groups. Both will get single knee joint injections into 1 knee. Either Arthrosamid or intra-articular steroid and bupivacaine. They will be blinded to what they have gotten. They will be followed up at 3, 6 , 12 and 18 months with MRI imaging and functional assessment to assess which is better.
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
Sponsors
Cappagh National Orthopaedic Hospital
Contura
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients blinded to treatment, Radiologists not blinded to which drug they are giving as they are prepared in distinct different ways. Radiologists reporting the MRI of the knee is blinded and will not to know which patient got what injection. Investigator using the data will be blinded with each patient given a unique identifier number.
Intervention model description
* Randomised control trial * 2 arms (Control vs. Treatment arm) * Approximately 50-100 patients in each arm * Single injection of standard of care treatment (steroid + local anaesthetic) vs. Arthrosamid. Patients will be randomly assigned to either. Patients identified and referred from orthopedic clinic. Adults with symptomatic knee pain. Patients with diagnosis of knee osteoarthritis radiographic Kellgren and Lawrence system OA grade II-III-IV. Both injections are given once with the patients blinded to which they are getting. The arthrosamid group requires pre procedure oral antibiotics 1-2 hours prior to injection. The steroid group will not get any antibiotics and will get separate information leaflet.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Arthritis Index (WOMAC). | Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months. | Self-administered questionnaire (24 items) assessing pain, stiffness, and physical function in patients with hip or knee osteoarthritis. Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MRI knee | Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months. | MRI of the affected knee with contrast to test for synovitis. |
| EuroQol-5 Dimension-5 Level health questionnaire. | Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months. | Questionnaire developed by the EuroQol Group to measure health-related quality of life. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. 1= no problem, 5 = maximum problems. Example shown below MOBILITY : 1. I have no problems in walking about 2. I have slight problems in walking about 3. I have moderate problems in walking about 4. I have severe problems in walking about 5. I am unable to walk about |
| Visual numerical pain rating scale (VNS) | Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months. | The Visual Numerical Scale (VNS) is a self-reported pain assessment tool that combines a 0-10 numeric scale with visual, pictorial, or graphic aids. 0 = no pain. 10 = worst pain possible |
Countries
Ireland
Contacts
CONTACTSEAN TEE LIM, M.D
CONTACTShane Crilly, MD
Outcome results
None listed