Evaluation of the Performance and Safety of a Single-dose Hyaluronic Acid (Promovia Hydro Balance) in the Treatment of Non-traumatic Degenerative Meniscus Tears

Обзор

Evaluation of the performance and safety of a single-dose hyaluronic acid (Promovia hydro balance) in the treatment of non-traumatic degenerative meniscus tears

Подробное описание

The aim of this study is to evaluate the performance of a single-dose intra-articular hyaluronic acid treatment (Promovia Hydro Balance 100 mg/4 mL; Innate S.r.l, Novi Ligure (AL), Italy) in restoring joint function and reducing associated pain. The safety of the treatment will also be assessed.

Primary objective: To evaluate, using the Knee Injury and Osteoarthritis Outcome Score (KOOS), the performance of intra-articular treatment with Promovia Hydro Balance at a 6-month follow-up (T6) in restoring joint function and improving associated pain in patients with non-traumatic degenerative meniscal tears.

Secondary objectives: To evaluate the performance of Promovia Hydro Balance in terms of improvement in overall pain, joint stiffness, and patient quality of life at 3 (T3) and 6 months (T6) following the injection. The safety of the treatment and the consumption of analgesics/NSAIDs will also be evaluated in the various phases of the study at the various follow-up times.

Вмешательства

• Устройство Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose
  Promovia Hydro Balance 100 mg

Первичные конечные точки

• Evalution T6 with Koos (Knee injury and Osteoarthritis Outcome Score): efficacy [Срок оценки: Change from Baseline in the evaluation at 6 Months]

Вторичные конечные точки (5)

• Performance evaluation T3 with Koos Questionnaire [Срок оценки: Change from Baseline in the evaluation at 3 Months]
• Evaluation of performance T3 with Womac (Western Ontario and McMaster Universities Arthritis Index) [Срок оценки: Change from Baseline in the evaluation at 3 Months]
• Numerical Rating Scale (NRS) at T3 compared to baseline [Срок оценки: Change from Baseline in NRS at 3 month from T0]
• Numerical Rating Scale (NRS) at 6 months [Срок оценки: Change from Baseline in NRS at 6 months from T0]
• Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 6 months [Срок оценки: Change from Baseline at time of 6 months.]

Критерии участия

Критерии включения

• \- Age between 35 and 75 years at the time of administration.
• Presence of a symptomatic degenerative meniscus tear, not related to acute trauma, documented by MRI.
• Positive meniscal tests.
• Pain intensity NRS ≥ 4.
• Willingness to participate in physical therapy or light exercise.
• Informed consent received, understood, and signed by the patient for active participation in the study and for the processing of personal data.
• Ability of the patient to understand the study conditions and to participate for the entire duration of the study.

Критерии исключения

• \- Patients with traumatic meniscus tears.
• Patients with a meniscal tear requiring surgical treatment (FLAP tear, radial tear, RAMP tear).
• Patients with severe knee osteoarthritis.
• Patients with axial deviation greater than 10°.
• Patients who have undergone meniscal or ligament surgery in the previous 12 months.
• Patients with rheumatic diseases or chondrocalcinosis.
• Patients with signs of possible infection in the affected joint or a skin disease involving the knee (e.g., dermatitis, psoriasis).
• Patients with diabetes.
• Patients with coagulopathies, platelet aggregation disorders, or those receiving oral anticoagulants or antiplatelet drugs.
• Patients receiving intra-articular corticosteroids or hyaluronic acid in the previous 12 months.
• Pregnant or breastfeeding patients.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO — Milan

Идентификаторы

NCT: NCT07539194 · PROHYBA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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