NCT Number: NCT07489521
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Phase 4
Dublin, D11 EV29, Ireland
Location status: Recruiting
Ciara Doran, MSc
SUB_INVESTIGATOR
SEAN TEE LIM, MD
CONTACT
Shane Crilly, M.D
SUB_INVESTIGATOR
Stephen Eustace, M.D
PRINCIPAL_INVESTIGATOR
Stephen Eustace, MD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
dexamethasone 8mg, methylprednisolone 80mg and bupivacaine 5ml 0.25%, intra articular injection
Time frame: 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).
Time frame: 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.
Time frame: 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 :
Time frame: 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
Contact information is provided by the study sponsor or research team.
Cappagh National Orthopaedic Hospital
Other
A Randomised Control Trial of the Use of an Intraarticular Hydrogel Arthrosamid® vs. Steroid for the Non-operative Management of Knee Osteoarthritis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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