Arthrosamid vs. Steroid for the Management of Knee Osteoarthritis

Официальное название

A Randomised Control Trial of the Use of an Intraarticular Hydrogel Arthrosamid® vs. Steroid for the Non-operative Management of Knee Osteoarthritis

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Arthrosamid® 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.
• Препарат Steroid Drug
  dexamethasone 8mg, methylprednisolone 80mg and bupivacaine 5ml 0.25%, intra articular injection

Первичные конечные точки

• Western Ontario and McMaster Universities Arthritis Index (WOMAC). [Срок оценки: Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.]

Вторичные конечные точки (3)

• MRI knee [Срок оценки: 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. [Срок оценки: Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.]
• Visual numerical pain rating scale (VNS) [Срок оценки: Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Ирландия · 1 центр

• Cappagh National Orthopaedic Hospital — Dublin

Идентификаторы

NCT: NCT07489521 · NOHC-2025-ETH-MB-CEO-388

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗