Efficacy and Safety of a Single Intraarticular Injection of Platelet-Rich Plasma on Pain and Physical Function in Patients With Ankle Osteoarthritis-a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- visual analog scale (VAS) of ankle pain
研究概览
简要总结
Platelet-rich plasma (PRP) has been reported to be an effective treatment for knee osteoarthritis (OA). The application in ankle OA has rarely been investigated. The aim was to evaluate the efficacy and safety of a single intraarticular injection of PRP for the treatment of patients with ankle OA.
详细描述
Methods: In a prospective study, patients with symptomatic ankle OA for at least 6 months were recruited. Patients received a single injection of 3-ml of PRP into symptomatic ankles. The primary outcome was the change from baseline in the visual analog scale (VAS) pain score (0-10cm) at 6 months. Secondary outcomes included the Ankle Osteoarthritis Scale (AOS) score, American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score, single leg stance test (SLS), use of rescue analgesics and patient satisfaction. Adverse events were recorded during the study.
Patients were followed at 1, 3 and 6 months postinjection .
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of at least twenty years
- •Ankle pain lasted for at least 6 months, despite conservative treatment or inability to tolerate the side effects of medications
- •Ankle radiographs taken within 6 months (reviewed by the senior author) were equivalent to grade 1-4 osteoarthritis by the Kellgren Lawrence grading system
- •Average ankle pain of > 3cm on a 10-cm visual analog scale (VAS)
- •Radiological evidence of bilateral ankle osteoarthritis was accepted if VAS pain in the contralateral ankle was < 3 cm
- •Normal activity level, not bedridden or confined to a wheelchair, able to walk 30 meters without the aid of a walker, crutches or cane
- •No use of physical therapy or changes in shoes or orthotic devices during the study
排除标准
- •Pregnancy or lactation in women
- •Lower leg trauma in a location other than within the ankle
- •Previous surgery involving the spine, hip or knee
- •The presence of an active infection of the ankle
- •Surgery involving the affected ankle within the previous 12 months
- •Intraarticular steroid or hyaluronate injection in the ankle within the previous 6 months
- •Treatment with anticoagulants or immunosuppressives
- •History of rheumatoid arthritis, gout, or other inflammatory arthropathy
- •The presence of visual or vestibular impairments
- •Poor health status (such as a neoplasm, diabetes mellitus, or paresis) that would interfere with the assessments
研究组 & 干预措施
PRP injection
Patients with symptomatic ankle OA for at least 6 months were recruited. Patients received a single injection of 3-ml of PRP into symptomatic ankles.
干预措施: PRP (Other)
结局指标
主要结局
visual analog scale (VAS) of ankle pain
时间窗: 6 months
The patient rated the average severity of ankle pain on ankle movement over the previous week on a 10-cm VAS (0=no pain to 10=worst possible pain)
次要结局
- The single-leg stance (SLS) test(6 months)
- global satisfaction(6 months)
- The Ankle Osteoarthritis Scale (AOS) score(6 months)
- The American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score(6 months)
- use of analgesic medication(through study completion, an average of 6 months)
- safety of PRP for ankle(through study completion, an average of 6 months)
研究者
Shu-Fen Sun
Director of Neutorehabilitation, MD,Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital
Kaohsiung Veterans General Hospital.