Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Contura | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arthrosamid | Experimental | Patient with knee osteoarthritis Arthrosamid Injection. This is a non-biodegradable 2.5% iPAAG injectable implant. It is given once. |
|
| Steroid | Active Comparator | Patient with knee osteoarthritis Steroid arm is as follow with one injection containing: Dexamethasone 8mg and methylprednisolone 80mg and bupivacaine 0.25% 5 mls. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities Arthritis Index (WOMAC). | 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). | Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| MRI knee | MRI of the affected knee with contrast to test for synovitis. | Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months. |
| EuroQol-5 Dimension-5 Level health questionnaire. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SEAN TEE LIM, M.D | Contact | (01) 814 0400 | seantee.lim@nohc.ie | |
| Shane Crilly, MD | Contact | (01) 814 0400 |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cappagh National Orthopaedic Hospital | Recruiting | Dublin | Dublin | D11 EV29 | Ireland |
De-identified individual participant data underlying published results will be available upon reasonable request following publication, subject to institutional approval and a data sharing agreement.
Data will be available beginning 6 months following publication of the primary results and will remain available for 5 years.
Access to de-identified individual participant data will be provided to qualified researchers upon reasonable request. Requests should include a methodologically sound research proposal and will be subject to approval by the study investigators and the host institution. Data will be shared following execution of a data sharing agreement and in compliance with applicable data protection regulations.
Not provided
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
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.
Not provided
Not provided
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.
|
| Steroid Drug | Drug | dexamethasone 8mg, methylprednisolone 80mg and bupivacaine 5ml 0.25%, intra articular injection |
|
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 :
| Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months. |
| Visual numerical pain rating scale (VNS) | 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 | Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months. |