Evaluation of the Performance and Safety of a Single-dose Hyaluronic Acid (Promovia Hydro Balance) in the Treatment of Non-traumatic Degenerative Meniscus Tears
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Evalution T6 with Koos (Knee injury and Osteoarthritis Outcome Score): efficacy
研究概览
简要总结
Evaluation of the performance and safety of a single-dose hyaluronic acid (Promovia hydro balance) in the treatment of non-traumatic degenerative meniscus tears
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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 ≥
- •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.
排除标准
- •- 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.
研究组 & 干预措施
Patients with non-traumatic degenerative meniscus lesions
干预措施: Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose (Device)
结局指标
主要结局
Evalution T6 with Koos (Knee injury and Osteoarthritis Outcome Score): efficacy
时间窗: Change from Baseline in the evaluation at 6 Months
To evaluate, through the Knee injury and Osteoarthritis Outcome Score (KOOS) functional score, the performance of intra-articular treatment with Promovia Hydro Balance at 6 months follow-up (T6) in the recovery of joint function and improvement of associated pain in patients affected by non-traumatic degenerative meniscus lesions
次要结局
- Performance evaluation T3 with Koos Questionnaire(Change from Baseline in the evaluation at 3 Months)
- Evaluation of performance T3 with Womac (Western Ontario and McMaster Universities Arthritis Index)(Change from Baseline in the evaluation at 3 Months)
- Numerical Rating Scale (NRS) at T3 compared to baseline(Change from Baseline in NRS at 3 month from T0)
- Numerical Rating Scale (NRS) at 6 months(Change from Baseline in NRS at 6 months from T0)
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 6 months(Change from Baseline at time of 6 months.)