Safety and Efficacy of Viscosupplementation of Hyaluronic Acid With Addition of Liposomes in Patients With Mild or Moderate Osteoarthrosis of the Knee Joint.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The pain score of Visual Analog Scale (VAS) of target knee at 3 months post-treatment.
研究概览
简要总结
The main objective of this prospective, open-label clinical trial is to assess the effectiveness and safety of intra-articular liposomal gel therapy for knee OA symptoms.
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
- 38 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 38 and 70 years,
- •OA diagnosed by the American College of Rheumatology (ACR) criteria,
- •OA diagnosed by radiographic imaging (grade II - III according to the Kellgren-Lawrence scale),
- •Pain in the knee joint for at least 3 months,
- •Screening pain intensity in the target knee measured on VAS scale was required to be 4 for symptomatic knee and 2 for the contralateral knee.
排除标准
- •Previous injections of hyaluronic acid or platelet-rich plasma within 6 months or corticosteroid injections within 3 months before the enrollment,
- •Present joint infection,
- •Previous knee arthroscopy up to 1 year prior to examination,
- •Peripheral inflammatory and autoimmune diseases that progress with joint involvement (rheumatoid arthritis, spondyloarthropathies, systemic lupus erythematosus etc.),
- •Total arthroplasty and osteotomy,
- •Ankylosis of the study joint,
- •Dermatitis or dermatological disease at the intended injection site,
- •Known hypersensitivity to the components of the preparation,
- •Coexistence of the degenerative changes in other limb joints (hip, foot),
- •Oral corticosteroid therapy,
- •Use of medicines that affect blood clotting (heparins, oral anticoagulants, thrombolytic drugs),
- •Pregnancy or breast-feeding.
- •History of injury to the knee, a broken bone or dislocation of a joint, other musculoskeletal diseases that affect the study joint, neoplastic disease.
- •Participation in other clinical trials.
研究组 & 干预措施
Study group
50 patients age 38-70 with OA confirmed by ACR criteria and radiologically verified OA (Kellgren-Lawrence grade 2 or 3) suffering from knee joint pain for at least 3 months and VAS pain score minimum 4 in one knee, and < 2 in the contralateral knee were subjected to the administration of Lipotris™. The product was administered as a course of three injections weekly.
干预措施: Intra-articular injection (Device)
结局指标
主要结局
The pain score of Visual Analog Scale (VAS) of target knee at 3 months post-treatment.
时间窗: 3 months
The visual analog scale (VAS) measures the severity of pain. The patient assesses the level of pain by marking a point on a line 10 cm long, where a value of 0 is assigned the complete absence of pain, and a value of 10 is assigned the most severe pain the patient can imagine.
次要结局
- Functional status of knee joint according to time to perform the Five Time Sit to Stand Test.(baseline, 1 month, 3 months and 6 months post-treatment)
- Maximum isometric force of flexor muscles of knee joint.(baseline, 1 month, 3 months and 6 months post-treatment)
- Maximum isometric force of extensor muscles of the knee joint.(baseline, 1 month, 3 months and 6 months post-treatment)
- The pain score of VAS of target knee at baseline, 1 week, 2 weeks, 1 month, and 6 months post-treatment(baseline, 1 week, 2 weeks, 1 month, and 6 months post-treatment)
- The score of WOMAC at baseline, 1 week, 2 weeks, 1 month, 3 months and 6 months post-treatment(baseline, 1 week, 2 weeks, 1 month, 3 months and 6 months post-treatment)
- Functional status of knee joint according to time to perform the The Timed Up and Go Test.(baseline, 1 month, 3 months and 6 months post-treatment)
- Functional status of knee joint according to time to perform the to 10 Meter Walk Test.(baseline, 1 month, 3 months and 6 months post-treatment)
- Safety assesment(baseline, 1 month, 3 months and 6 months post-treatment)