Hyaluronans in the Treatment of Ankle Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 6 Months
研究概览
简要总结
The aim of this study was to investigate the efficacy and safety of three weekly intraarticular injections of Hyaluronate (HA) in patients with unilateral ankle Osteoarthritis (OA).
详细描述
Viscosupplementation with 3 to 5 weekly hyaluronate injections is a well-established treatment option in knee osteoarthritis. Previous studies reported that five weekly hyaluronate injections were safe and effective for the treatment of ankle osteoarthritis. However, the effect of three weekly injections has rarely been investigated. Besides, no study to date has assessed whether balance function would change after HA injections in patients with ankle OA. The purpose of this study was to evaluate the efficacy and safety of three weekly injections of sodium hyaluronate (Hyalgan) in patients with unilateral ankle osteoarthritis. Pain, physical function and balance will be assessed as parameters for the effectiveness.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •were 18 years of age or older, reported unilateral ankle pain for at least 6 months and had either reported no significant benefit from conservative treatment (rest, physical therapy, orthoses or pain medications etc.) or were unable to tolerate side effects of medications
- •ankle radiographs taken within 6 months were equivalent to grade 2 or 3 according to the Kellgren-Lawrence grading system (grade 2, definite osteophytes and possible narrowing of joint space; grade 3, moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and possible deformity of bone contour)22
- •had a current total AOS score (described below) of > 3 and < 9 (possible range, 0-10)
- •were normally active, not bedridden or confined to a wheelchair, and were able to walk 30 meters without the aid of a walker, crutches or cane
- •were willing to discontinue all nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesic medication (except for rescue medication) for the duration of the study
- •did not receive physical therapy or trial of shoe modifications or orthotics during the study period
排除标准
- •pregnant and lactating women
- •bilateral ankle OA requiring treatment of both ankles
- •chronic ankle instability
- •lower leg trauma other than within the ankle
- •previous orthopedic surgery on the spine, hip or knee
- •presence of active joint infections of foot or ankle
- •previous surgery or arthroscopy on the ankle within 12 months
- •intraarticular steroid or HA injection in the treated ankle within the past 6 months
- •treatment with anticoagulants or immunosuppressives
- •history of rheumatoid arthritis, gout, or any other inflammatory arthropathy
- •history of avian protein allergy
- •presence of other comorbidity (neoplasm, diabetes mellitus, paresis, recent trauma, etc) or poor health status that would interfere with the clinical assessments during the study
研究组 & 干预措施
hyaluronate injection
All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
干预措施: sodium hyaluronate (Drug)
结局指标
主要结局
Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 6 Months
时间窗: baseline and 6 months
The AOS is a patient-rated, validated outcome measure that includes nine items on a pain subscale and nine items on a disability subscale. Using the AOS, a score of 0 represent no pain or disability and 10 represent worst pain or disability imaginable
次要结局
- The American Orthopedic Foot and Ankle Society (AOFAS) Ankle/Hindfoot Score(6 months)
- Ankle Sagittal Range of Motion(6 months)
- Four Clinical Balance Tests(6 months)
- the Level of Global Satisfaction Based on a 7-point Categorical Scale(6 months)
- Systemic and Local Adverse Events Recording(6 months)
- Rescue Acetaminophen Consumption(6 months)