Efficacy of Platelet-rich Plasma in the Treatment of Chronic Lateral Ankle Instability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 3-month postoperative ankle function evaluated by AOFAS Ankle-Hindfoot score
研究概览
简要总结
This study aims to evaluate the effect of platelet-rich plasma (PRP) on chronic lateral ankle instability by comparing the imaging and clinical outcomes between patients receiving PRP and those receiving whole blood during the modified Broström-Gould procedure.
详细描述
Chronic lateral ankle instability (CAI) in a common foot and ankle problem. It has been linked to recurrent ankle pain, swelling, and even early degenerative change if not properly treated. Lateral ligament reconstruction using modified Broström-Gould procedure is the mainstream in treatment of CAI. Early mobilization is related to better functional outcome, and rapid healing of the repair is the key point to shorten the immobilization time. Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets and multiple growth factors concentrated at high level. Because activated platelets have the potential to release growth factors, PRP has been clinically used to accelerate wound healing and tissue regeneration. However, there is no conclusion regarding the efficacy of PRP on CAI. This clinical trial will investigate the effect of PRP on CAI. Eligible patients will be randomly assigned to receive PRP or whole blood during the modified Broström-Gould procedure. The postoperative imaging and clinical outcomes will be compared and analyzed.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 60 years
- •With diagnosis of chronic lateral ankle instability
排除标准
- •Poor controlled diabetes
- •Peripheral artery obstructive disease
- •Skin or soft tissue infection at ankle
- •With current or prior history of ankle disease, including degeneration arthritis, fracture, deformity, and cartilage disease.
- •With prior history of ankle surgery
- •With current or prior history of cancer
- •With current or prior history of hematological disease
- •Pregnancy
研究组 & 干预措施
Control group
15 patients will receive whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament.
干预措施: Control (Other)
PRP group
15 patients will receive platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament.
干预措施: Platelet-rich plasma (Other)
结局指标
主要结局
3-month postoperative ankle function evaluated by AOFAS Ankle-Hindfoot score
时间窗: 3-month postoperative
Ankle function is evaluated by AOFAS Ankle-Hindfoot score
次要结局
- 3-month postoperative ankle pain evaluated by visual analogue scale(3-month postoperative)
- 3-month postoperative anterior displacement of ankle evaluated by stress radiographs of anterior drawer test(3-month postoperative)
- 3-month postoperative lateral tilt of ankle evaluated by stress radiographs of talar tilt test(3-month postoperative)
- Percentage of patients with healed ligament evaluated by MRI(3-month postoperative)
- Percentage of patients with healed ligament evaluated by second look arthroscopy(3-month postoperative)
研究者
Pei-Yuan Lee, MD
Superintendent
Show Chwan Memorial Hospital