The Efficacy and Safety of Intraarticular Sodium Hyaluronate (Hyalgan) After Proximal Tibial Osteotomy in Treatment of Knee Osteoarthritis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Joint Space Width
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of Hyalgan after proximal tibial osteotomy in treatment of knee osteoarthritis patients. Normally, OA patients who were treated with osteotomy will not be treated with any SYSADOA after operation, even though their cartilage's not completely loss, so osteotomy plus HA injection should provide more benefit to patients than osteotomy alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 35 and 65 years with primary knee OA with malalignment
- •Mild to moderate OA of grade II or III severity on the Kellgren-Lawrence scale with require treatment by osteotomy
- •Malalignment is not exceed 15 degree (+,-)
- •Pain on walking (15 m) ≥ 40 mm.
- •Range of motion > 90 degree
- •Evidence of adequate contraceptive methods in women of childbearing age
排除标准
- •Previous surgery on affected knee
- •Previous intraarticular intervention within the last 3 months (eg. Steroid, anaesthetic, Sodium hyaluronate)
- •Oral SYSADOA treatment (chondroitin, glucosamine, diacerein) within 2 months prior to study start
- •Known or suspected infection of the affected joint
- •Painful knee condition due to another cause than chondral lesions, such as Sudeck's atrophy, intraarticular neoplasm, pigmented villonodular synovitis, chondromatosis
- •Poor general health or other conditions which would make regular hospital attendance difficult
- •Ascertained hypersensitivity to any component used in the study (eg. Hyaluronic acid, diclofenac, morphine, omeprazole and paracetamol)
- •Hypersensitivity to avian protein
- •Ongoing or previous participation in a clinical study within the last 3 months
研究组 & 干预措施
Osteotomy alone
干预措施: Osteotomy alone (Procedure)
Osteotomy plus Hyalgan
Osteotomy at Week 0 Hyalgan injection at Week 2, 3, 4, 5, 6, 24, 25, 26, 27, 28
干预措施: Sodium Hyaluronate (Hyalgan) (Drug)
结局指标
主要结局
Joint Space Width
时间窗: 12 months
WOMAC section A, B, C
时间窗: 12 months
Pain score
Global assessment
时间窗: 12 months
assess by Patient and investigator
Rescue medicine consumption
时间窗: 12 months
Diclofenac consumption
次要结局
未报告次要终点