Arthrosamid vs. Steroid for the Management of Knee Osteoarthritis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-100
SponsorCappagh National Orthopaedic Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Inflammatory conditions,
Cancer,
acute infection,
pregnancy and breastfeeding.
Trial design
Design model
Parallel
Treatments tested in this trial
Arthrosamid® 2.5% iPAAG injectable implant
DeviceArthrosamid 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.
Steroid Drug
Drugdexamethasone 8mg, methylprednisolone 80mg and bupivacaine 5ml 0.25%, intra articular injection
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: ArthrosamidExperimental treatment 1 intervention
Group B: SteroidActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.Secondary outcomes
1
MRI knee
MRI of the affected knee with contrast to test for synovitis.
Time frame
Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.2
EuroQol-5 Dimension-5 Level health questionnaire.
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
Time frame
Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.3
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
Time frame
Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cappagh National Orthopaedic Hospital
Lead sponsor
Contura
Collaborator
Source ClinicalTrials.gov