A Randomized Clinical Trial Comparing Hyaluronic Acid (Hylan G-F 20) and Corticosteroid (Methylprednisolone Acetate) for Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- The primary outcome will be "pain while walking for approximately 30 minutes on a flat surface today" as reported by the patient on a 100mm unmarked VAS (0 = no pain; 100 = worst pain possible).
研究概览
简要总结
Do differences exist between patients who receive a single intra-articular injection of corticosteroid versus patients who receive a single intra-articular injection of hyaluronic acid for the treatment of knee osteoarthritis at 1, 3 and 6 weeks, and 3 and 6 months post injection?
详细描述
OBJECTIVES
Primary i. To determine if patients' VAS "pain while walking" is different at 6 weeks post-injection in patients who receive a single injection of methylprednisolone acetate (MPA) versus patients who receive a single injection of Hylan G-F 20 (Synvisc One™) for treatment of knee OA.
Secondary i. To determine if differences in VAS "pain while walking" scores exist at 1 and 3 weeks, and 3 and 6 months post injection between MPA and HA patients.
ii. To determine if differences in VAS "pain at rest" scores exist at 1, 3 and 6 weeks and 3 and 6 months post injection between MPA and HA patients.
iii. To determine if differences in VAS "pain with stairs" scores exist at 1, 3 and 6 weeks and 3 and 6 months post injection between MPA and HA patients.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19-75 years of age (inclusive)
- •Symptomatic OA (1 of the following: pain, stiffness, or swelling)
- •Evidence of grade I, II or III OA on radiographic images according to Kellgren-Lawrence grading scale.
排除标准
- •Previous surgery on either knee (not including a diagnostic arthroscopy arthroscopy or simple partial meniscectomy)
- •Intra-articular treatment within the last 3 months
- •Ipsilateral cruciate or collateral ligament injury within past 3 months, or evidence of ligament laxity
- •Inflamed knee or pronounced effusion
- •Allergy to birds, eggs, avian proteins or known HA or corticosteroid
- •Venous or lymphatic stasis
- •Skin condition in the injection area
- •Evidence of infection in the affected joint
- •History of crystalline arthropathy or inflammatory arthritis
- •Pregnant or nursing
- •Third Party, Medical Legal or Workers' Compensation Board
- •Patient unable to understand English or unable to providing informed consent
研究组 & 干预措施
Hyaluronic Acid (HA) Injection
Patients allocated to the HA group will receive a single IA injection Hylan G-F 20 Synvisc One™ (1 injection of 6cc's). All injections will be administered as outlined on the company label. Aspiration of the knee will not be performed.
干预措施: Hylan G-F 20 (Synvisc One) (Device)
Corticosteroid Injection
Patients allocated to the corticosteroid injection will receive a single IA injection of 80mg of methylprednisolone acetate (1cc of solution) mixed with 5cc's of 1% lidocaine without epinephrine for a total of 6cc's. The injection will be administered as outlined on the company label. Aspiration of the knee will not be performed.
干预措施: Methylprednisolone (Corticosteroid) (Drug)
结局指标
主要结局
The primary outcome will be "pain while walking for approximately 30 minutes on a flat surface today" as reported by the patient on a 100mm unmarked VAS (0 = no pain; 100 = worst pain possible).
时间窗: VAS Form will be given at baseline (prior to injection) and then at 1, 3 and 6 weeks, and 3 and 6 months post injection.
As described in title
次要结局
- Pain at rest or with stairs as reported byu the patient on a VAS(Baseline (pre-injection), 1, 3 and 6 weeks, and 3 and 6 months post injection)